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What changed in OCULAR THERAPEUTIX, INC's 10-K — 2024 vs 2025

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Paragraph-level year-over-year comparison of OCULAR THERAPEUTIX, INC's 2024 and 2025 10-K annual filings, covering the Business, Risk Factors, Legal Proceedings, Cybersecurity, MD&A and Market Risk sections. Every new, removed and edited paragraph is highlighted side-by-side so you can see exactly what management changed in the 2025 report.

+529 added−1122 removedSource: 10-K (2026-02-05) vs 10-K (2025-03-03)

Top changes in OCULAR THERAPEUTIX, INC's 2025 10-K

529 paragraphs added · 1122 removed · 379 edited across 7 sections

Item 1. Business

Business — how the company describes what it does

287 edited+104 added−715 removed482 unchanged
Biggest changeThe anti-VEGF market for the treatment of wet AMD consists predominantly of four drugs that are approved for marketing and primarily prescribed for the treatment of wet AMD: Eylea and Eylea HD, marketed in the United States by Regeneron; Lucentis, marketed in the United States by Genentech; and Vabysmo, marketed in the United States by Genentech.
Biggest changeThe market for the treatment of wet AMD consists predominantly of five anti- VEGF, drugs, including four drugs that are approved for marketing and primarily prescribed for the treatment of wet AMD: Eylea and Eylea HD, marketed in the United States by Regeneron; Lucentis, marketed in the United States by Genentech; Vabysmo, marketed in the United States by Genentech, and one drug, bevacizumab, also known as Avastin, an anti-VEGF therapy approved for the treatment of certain cancers, which is used off-label for the treatment of wet AMD. ​ Diabetic Retinal Disease Diabetic retinal diseases are an increasingly prevalent global health concern, driven by the rapidly rising number of individuals diagnosed with diabetes each year. 7 Table of Contents Diabetic retinopathy, or DR, is the most common category of retinal diseases, affecting over an estimated 103 million people worldwide.
The FDA may meet with sponsors, provided certain conditions are met, for the purpose of reaching an SPA agreement on the design and size of clinical trials intended to form the primary basis of an efficacy claim in a marketing application.
The FDA may meet with sponsors, provided certain conditions are met, for the purpose of reaching a SPA agreement on the design and size of clinical trials intended to form the primary basis of an efficacy claim in a marketing application.
As originally enacted by the Balanced Budget Refinement Act of 1999, this provision required Centers for Medicare and Medicaid Services, or CMS, to make additional payments to hospitals for current orphan drugs, as designated under section 526 of the FDCA; current drugs and biological agents and brachytherapy sources used for the treatment of cancer; and current radiopharmaceutical drugs and biological products.
As originally enacted by the Balanced Budget Refinement Act of 1999, this provision required the Centers for Medicare and Medicaid Services, or CMS, to make additional payments to hospitals for current orphan drugs, as designated under section 526 of the FDCA; current drugs and biological agents and brachytherapy sources used for the treatment of cancer; and current radiopharmaceutical drugs and biological products.
In November 2024, the CY 2025 MPFS rule was finalized resulting in a marginal decrease in physician payments compared to 2024 to $31.38 in the ASCs and HOPDs and $36.88 in the physician’s office for unilateral insertion, due to a decrease in the conversion factor which CMS uses to translate the relative value units, or RVUs, of medical services into fee schedule payment amounts.
In November 2024, the CY 2025 MPFS rule was finalized resulting in a marginal decrease in physician payments compared to 2024 to $31.38 in the ASCs and HOPDs and $36.88 in the physician’s office for unilateral insertion, due to a decrease in the conversion factor, or the Conversion Factor, which CMS uses to translate the relative value units, or RVUs, of medical services into fee schedule payment amounts.
A sponsor seeking approval to market and distribute a new drug or biological product in the United States must typically undertake the following: ● completion of preclinical laboratory tests, animal studies and formulation studies in compliance with the FDA’s good laboratory practice, or GLP, regulations; ● design of a clinical protocol and submission to the FDA of an IND, which must take effect before human clinical trials may begin; ● approval by an independent institutional review board, or IRB, representing each clinical site before each clinical trial may be initiated; ● performance of adequate and well-controlled human clinical trials in accordance with GCPs, to establish the safety and efficacy of the proposed drug product or the safety, potency and purity for the proposed biological product for each indication; ● preparation and submission to the FDA of a new drug application, or NDA, demonstrating the safety and efficacy for the drug candidate product or, with respect to biologics, a biological licensing application, or BLA, demonstrating the safety, purity and potency of the proposed biological product for one or more proposed indications; ● review by an FDA advisory committee, where appropriate or if applicable; ● satisfactory completion of one or more FDA inspections of the manufacturing facility or facilities at which the product, or components thereof, are produced to assess compliance with current Good Manufacturing Practices, or cGMP, requirements and to assure that the facilities, methods and controls are adequate to preserve the product’s identity, strength, quality and purity; ● satisfactory completion of FDA audits of clinical trial sites to assure compliance with GCPs and the integrity of clinical data; ● payment of user fees pursuant to the Prescription Drug User Fee Act; 26 Table of Contents ● securing FDA approval of the NDA or BLA authorizing marketing of the new drug product or biological product in the United States; and ● compliance with any post-approval requirements, including the potential requirement to implement a Risk Evaluation and Mitigation Strategy, or REMS, and the potential requirement to conduct post-approval studies.
A sponsor seeking approval to market and distribute a new drug or biological product in the United States must typically undertake the following: ● completion of preclinical laboratory tests, animal studies and formulation studies in compliance with the FDA’s good laboratory practice, or GLP, regulations; ● design of a clinical protocol and submission to the FDA of an IND, which must take effect before human clinical trials may begin; ● approval by an independent institutional review board, or IRB, representing each clinical site before each clinical trial may be initiated; ● performance of adequate and well-controlled human clinical trials in accordance with GCPs, to establish the safety and efficacy of the proposed drug product or the safety, potency and purity for the proposed biological product for each indication; ● preparation and submission to the FDA of a new drug application, or NDA, demonstrating the safety and efficacy for the drug candidate product or, with respect to biologics, a biological licensing application, or BLA, demonstrating the safety, purity and potency of the proposed biological product for one or more proposed indications; ● review by an FDA advisory committee, where appropriate or if applicable; ● satisfactory completion of one or more FDA inspections of the manufacturing facility or facilities at which the product, or components thereof, are produced to assess compliance with current Good Manufacturing Practices, or cGMP, requirements and to assure that the facilities, methods and controls are adequate to preserve the product’s identity, strength, quality and purity; 29 Table of Contents ● satisfactory completion of FDA audits of clinical trial sites to assure compliance with GCPs and the integrity of clinical data; ● payment of user fees pursuant to the Prescription Drug User Fee Act; ● securing FDA approval of the NDA or BLA authorizing marketing of the new drug product or biological product in the United States; and ● compliance with any post-approval requirements, including the potential requirement to implement a Risk Evaluation and Mitigation Strategy, or REMS, and the potential requirement to conduct post-approval studies.
These requirements include compliance with European Union cGMP standards when manufacturing medicinal products and active pharmaceutical ingredients, including the manufacture of active pharmaceutical ingredients outside of the European Union with the intention to import the active pharmaceutical ingredients into the European Union. ● The marketing and promotion of authorized drugs, including industry-sponsored continuing medical education and advertising directed toward the prescribers of drugs and/or the general public, are strictly regulated in the European Union notably under Directive 2001/83EC, as amended, and European Union Member State laws.
These requirements include compliance with EU cGMP standards when manufacturing medicinal products and active pharmaceutical ingredients, including the manufacture of active pharmaceutical ingredients outside of the European Union with the intention to import the active pharmaceutical ingredients into the European Union. ● The marketing and promotion of authorized drugs, including industry-sponsored continuing medical education and advertising directed toward the prescribers of drugs and/or the general public, are strictly regulated in the European Union notably under Directive 2001/83EC, as amended, and EU Member State laws.
One subject died during the HELIOS trial due to reasons unrelated to the trial and study treatment. In June 2024, we announced topline data from the HELIOS trial at 48 weeks. AXPAXLI was generally well-tolerated and did not result in any reported incidence of intraocular inflammation, iritis, vitritis, or vasculitis. No subjects in either arm received rescue medication.
One subject died during the HELIOS-1 trial due to reasons unrelated to the trial and study treatment. In June 2024, we announced topline data from the HELIOS-1 trial at 48 weeks. AXPAXLI was generally well-tolerated and did not result in any reported incidence of intraocular inflammation, iritis, vitritis, or vasculitis. No subjects in either arm received rescue medication.
As of May 2024, five states (Colorado, Florida, Maine, New Hampshire and New Mexico) had submitted Section 804 Importation Program proposals to the FDA. On January 5, 2023, the FDA approved Florida’s plan for Canadian product importation. That state now has authority to import certain products from Canada for a period of two years once certain conditions are met.
As of May 2024, five states (Colorado, Florida, Maine, New Hampshire and New Mexico) had submitted Section 804 Importation Program proposals to the FDA. On January 5, 2024, the FDA approved Florida’s plan for Canadian product importation. That state now has authority to import certain products from Canada for a period of two years once certain conditions are met.
An SPC may extend the term of a patent for up to five years after its originally scheduled expiration date and can provide up to a maximum of fifteen years of marketing exclusivity for a drug. In certain circumstances, these periods may be extended for six additional months if pediatric exclusivity is obtained.
An SPC may extend the term of a patent right for up to five years after its originally scheduled expiration date and can provide up to a maximum of fifteen years of marketing exclusivity for a drug. In certain circumstances, these periods may be extended for six additional months if pediatric exclusivity is obtained.
Compliance with the GDPR is a rigorous and time-intensive process that may increase the cost of doing business or require companies to change their business practices to ensure full compliance. In July 2020, the Court of Justice of the European Union, or the CJEU, invalidated the European Union-U.S.
Compliance with the GDPR is a rigorous and time-intensive process that may increase the cost of doing business or require companies to change their business practices to ensure full compliance. In July 2020, the Court of Justice of the European Union, or the CJEU, invalidated the EU-U.S.
AffaMed License Agreement Under the terms of the AffaMed License Agreement, we received an upfront payment of $12 million and became eligible to receive development, regulatory and commercial milestone payments and clinical development support payments of up to $91 million in the aggregate, as well as royalties from future product sales.
AffaMed License Agreement Under the terms of the AffaMed License Agreement, we received an upfront payment of $12.0 million and became eligible to receive development, regulatory and commercial milestone payments and clinical development support payments of up to $91.0 million in the aggregate, as well as royalties from future product sales.
Sales of products will depend, in part, on the extent to which the costs of the products will be covered by third-party payors, including government health programs in the United States such as Medicare and Medicaid, commercial health insurers and managed care organizations.
Sales of products will depend, in part, on the extent to which the costs of the products will be covered by third-party payors, including government healthcare programs in the United States such as Medicare and Medicaid, commercial health insurers and managed care organizations.
No subjects in the AXPAXLI group experienced any worsening in DRSS. Two of eight (25.0%) subjects in the control group experienced worsening in the DRSS at 48 weeks. No subjects in the AXPAXLI group developed PDR or CI-DME at week 48. Three of eight (37.5%) subjects in the control group developed PDR or CI-DME at the same timepoint.
Two of eight (25.0%) subjects in the control group experienced worsening in the DRSS at 48 weeks. No subjects in the AXPAXLI group developed PDR or CI-DME at week 48. Three of eight (37.5%) subjects in the control group developed PDR or CI-DME at the same timepoint.
These include but are not limited to: ● submitting and updating establishment registration and device listings with the FDA; ● compliance with the QSR, which require manufacturers to follow stringent design, testing, control, documentation, record maintenance, including maintenance of complaint and related investigation files, and other quality assurance controls during the manufacturing process; ● unannounced routine or for-cause device inspections by the FDA, which may include our suppliers’ facilities labeling regulations, which prohibit the promotion of products for uncleared or unapproved or “off-label” uses and impose other restrictions on labeling; and 43 Table of Contents ● post-approval restrictions or conditions, including requirements to conduct post-market surveillance studies to establish continued safety data or tracking products through the chain of distribution to the patient level.
These include but are not limited to: ● submitting and updating establishment registration and device listings with the FDA; ● compliance with the QSR, which require manufacturers to follow stringent design, testing, control, documentation, record maintenance, including maintenance of complaint and related investigation files, and other quality assurance controls during the manufacturing process; ● unannounced routine or for-cause device inspections by the FDA, which may include our suppliers’ facilities labeling regulations, which prohibit the promotion of products for uncleared or unapproved or “off-label” uses and impose other restrictions on labeling; and ● post-approval restrictions or conditions, including requirements to conduct post-market surveillance studies to establish continued safety data or tracking products through the chain of distribution to the patient level.
AffaMed License Agreement On October 29, 2020, we entered into the AffaMed License Agreement with AffaMed for the development and commercialization of DEXTENZA regarding ocular inflammation and pain following cataract surgery and allergic conjunctivitis, or collectively, the DEXTENZA Field, and for PAXTRAVA, or collectively with DEXTENZA, the AffaMed Licensed Products, regarding OAG and OHT, or collectively, the TIC Field and, with the DEXTENZA Field, each a Field, in each case in mainland China, Taiwan, Hong Kong, Macau, South Korea, and the countries of the Association of Southeast Asian Nations, or collectively, the Territories.
AffaMed License Agreement On October 29, 2020, we entered into the AffaMed License Agreement with AffaMed for the development and commercialization of DEXTENZA regarding ocular inflammation and pain following cataract surgery and allergic conjunctivitis, or collectively, the DEXTENZA Field, and for OTX-TIC, or collectively with DEXTENZA, the AffaMed Licensed Products, regarding OAG and OHT, or collectively, the TIC Field and, with the DEXTENZA Field, each a Field, in each case in mainland China, Taiwan, Hong Kong, Macau, South Korea, and the countries of the Association of Southeast Asian Nations, or collectively, the Territories.
These rules can impose post-authorization studies and additional monitoring obligations. ● The manufacturing of authorized medicinal products, for which a separate manufacturer’s license is mandatory, must also be conducted in strict compliance with the applicable European Union laws, regulations and guidance, including Directive 2001/83/EC, Directive 2003/94/EC, Regulation (EC) No 726/2004 and the European Commission Guidelines for Good Manufacturing Practice.
These rules can impose post-authorization studies and additional monitoring obligations. ● The manufacturing of authorized medicinal products, for which a separate manufacturer’s license is mandatory, must also be conducted in strict compliance with the applicable EU laws, regulations and guidance, including Directive 2001/83/EC, Directive 2003/94/EC, Regulation (EC) No 726/2004 and the European Commission Guidelines for Good Manufacturing Practice.
When considering an IND application for expanded access to an investigational product with the purpose of treating a patient or a group of patients, the sponsor and treating physicians or investigators will determine suitability when all of the following criteria apply: patient(s) have a serious or immediately life-threatening disease or condition, and there is no comparable or satisfactory alternative therapy to diagnose, monitor, or treat the disease or condition; the potential patient benefit justifies the potential risks of the treatment and the potential risks are not unreasonable in the context or condition to be treated; and the expanded use of the investigational drug for the requested treatment will not interfere initiation, conduct, or completion of clinical investigations that could support marketing approval of the product or otherwise compromise the potential development of the product.
When considering an IND application for expanded access to an investigational product with the purpose of treating a patient or a group of patients, the sponsor and treating physicians or investigators will determine suitability when all of the following criteria apply: patient(s) have a serious or immediately life-threatening disease or condition, and there is no comparable or satisfactory alternative therapy to diagnose, monitor, or treat the disease or condition; the 31 Table of Contents potential patient benefit justifies the potential risks of the treatment and the potential risks are not unreasonable in the context or condition to be treated; and the expanded use of the investigational drug for the requested treatment will not interfere initiation, conduct, or completion of clinical investigations that could support marketing approval of the product or otherwise compromise the potential development of the product.
Exceptional Circumstances A MA may also be granted “under exceptional circumstances” under Article 14(8) of Regulation (EC) No 726/2004 when the applicant can show that it is unable to provide comprehensive data on the efficacy and safety under normal conditions of use even after the product has been authorized and subject to specific procedures being introduced.
Exceptional Circumstances An MA may also be granted “under exceptional circumstances” under Article 14(8) of Regulation (EC) No 726/2004 when the applicant can show that it is unable to provide comprehensive data on the efficacy and safety under normal conditions of use even after the product has been authorized and subject to specific procedures being introduced.
In January 2025, we submitted a second SPA agreement modification to the FDA to add a repeat dose of AXPAXLI 450 µg at Week 52 and at Week 76, in each case, after all pre-defined efficacy endpoint assessments, to generate the required safety data for subjects re-dosed with AXPAXLI through Week 104, to support long-term dosing.
In January 2025, we submitted a subsequent SPA agreement modification to the FDA to add a repeat dose of AXPAXLI 450 µg at Week 52 and at Week 76, in each case, after all pre-defined efficacy endpoint assessments, to generate the required safety data for subjects re-dosed with AXPAXLI 450 μg through Week 104, to support long-term dosing.
The term “substantial evidence” is defined under the FDCA as “evidence consisting of adequate and well-controlled investigations, including clinical investigations, by experts qualified by scientific training and experience to evaluate the 34 Table of Contents effectiveness of the product involved, on the basis of which it could fairly and responsibly be concluded by such experts that the product will have the effect it purports or is represented to have under the conditions of use prescribed, recommended, or suggested in the labeling or proposed labeling thereof.” The FDA has interpreted this evidentiary standard to require at least two adequate and well-controlled clinical investigations to establish effectiveness of a new product.
The term “substantial evidence” is defined under the FDCA as “evidence consisting of adequate and well-controlled investigations, including clinical investigations, by experts qualified by scientific training and experience to evaluate the effectiveness of the product involved, on the basis of which it could fairly and responsibly be concluded by such experts that the product will have the effect it purports or is represented to have under the conditions of use prescribed, recommended, or suggested in the labeling or proposed labeling thereof.” The FDA has interpreted this evidentiary standard to require at least two adequate and well-controlled clinical investigations to establish effectiveness of a new product.
Under FDA’s regulations, a combination product is defined to include: a product comprised of two or more regulated components that are physically, chemically, or otherwise combined or mixed and produced as a single entity (a “single-entity” combination product); ● two or more separate products packaged together in a single package or as a unit and comprised of drug and device products, device and biological products, or biological and drug products (“co-packaged” combination product); ● a drug, device, or biological product packaged separately that according to its investigational plan or proposed labeling is intended for use only with an approved individually specified drug, device, or biological product (a “cross-labeled” combination product); or 44 Table of Contents ● any investigational drug, device, or biological product packaged separately that according to its proposed labeling is for use only with another individually specified investigational drug, device, or biological product where both are required to achieve the intended use, indication, or effect (a “cross-labeled” investigational combination product).
Under FDA’s regulations, a combination product is defined to include: a product comprised of two or more regulated components that are physically, chemically, or otherwise combined or mixed and produced as a single entity (a “single-entity” combination product); ● two or more separate products packaged together in a single package or as a unit and comprised of drug and device products, device and biological products, or biological and drug products (“co-packaged” combination product); ● a drug, device, or biological product packaged separately that according to its investigational plan or proposed labeling is intended for use only with an approved individually specified drug, device, or biological product (a “cross-labeled” combination product); or ● any investigational drug, device, or biological product packaged separately that according to its proposed labeling is for use only with another individually specified investigational drug, device, or biological product where both are required to achieve the intended use, indication, or effect (a “cross-labeled” investigational combination product).
Our own approved product DEXTENZA, the first and only drug-eluting intracanalicular insert approved by the FDA, has been used in nearly 550,000 eyes since launch with reported adverse events in approximately 2 of every 10,000 patients. As a result, we believe that the ELUTYX technology is well tolerated.
Our own approved product DEXTENZA, the first and only drug-eluting intracanalicular insert approved by the FDA, has been used in nearly 750,000 eyes since launch with reported adverse events in approximately 2 of every 10,000 patients. As a result, we believe that the ELUTYX technology is well tolerated.
We consider the following selection criteria: ● prior approval by the FDA for the targeted ophthalmic indication, ● scientific rationale, either clinical or pre-clinical, for active pharmaceutical ingredients such as axitinib, which are not currently approved for an ophthalmic indication; ● expiration of relevant patent protection prior to or within our anticipated development timeline; ● high potency to minimize required drug load in the intravitreal hydrogel, intracameral hydrogel or intracanalicular insert; 15 Table of Contents ● availability from a qualified supplier; and ● compatibility with our drug delivery system.
We consider the following selection criteria: ● prior approval by the FDA for the targeted ophthalmic indication, ● scientific rationale, either clinical or pre-clinical, for active pharmaceutical ingredients such as axitinib, which are not currently approved for an ophthalmic indication; ● expiration of relevant patent protection prior to or within our anticipated development timeline; ● high potency to minimize required drug load in the intravitreal hydrogel, intracameral hydrogel or intracanalicular insert; ● availability from a qualified supplier; and ● compatibility with our drug delivery system.
In the trial, the PAXTRAVA 26 µg single hydrogel implant demonstrated consistent control of IOP, through six months, as statistically significant IOP changes from baseline were observed for every individual and mean diurnal measurement at primary endpoints Week 2 (M0.5), Week 6 (M1.5), and Week 12 (M3), as well as secondary endpoints Months 4.5 and 6 (p PAXTRAVA 26 µg was generally well tolerated with no impact on the corneal endothelium having been observed at six months following a single administration of the product candidate.
In the trial, the OTX-TIC 26 µg single hydrogel implant demonstrated consistent control of IOP, through six months, as statistically significant IOP changes from baseline were observed for every individual and mean diurnal measurement at primary endpoints Week 2 (M0.5), Week 6 (M1.5), and Week 12 (M3), as well as secondary endpoints Months 4.5 and 6 (p OTX-TIC 26 µg was generally well tolerated with no impact on the corneal endothelium having been observed at six months following a single administration of the product candidate.
The failure to comply with applicable regulatory requirements can result in enforcement action by the FDA, which may include any of the following sanctions: ● untitled letters, warning letters, fines, injunctions or civil penalties; ● recalls, detentions or seizures of products; ● operating restrictions; ● delays in the introduction of products into the market; ● total or partial suspension of production; ● delay or refusal of the FDA or other regulators to grant 510(k) clearance or PMA application approvals of new products; ● withdrawals of 510(k) clearance or PMA application approvals; or ● in the most serious cases, criminal prosecution.
The failure to comply with applicable regulatory requirements can result in enforcement action by the FDA, which may include any of the following sanctions: ● untitled letters, warning letters, fines, injunctions or civil penalties; ● recalls, detentions or seizures of products; ● operating restrictions; ● delays in the introduction of products into the market; ● total or partial suspension of production; ● delay or refusal of the FDA or other regulators to grant 510(k) clearance or PMA application approvals of new products; 47 Table of Contents ● withdrawals of 510(k) clearance or PMA application approvals; or ● in the most serious cases, criminal prosecution.
We and any of our sublicensees are obligated to pay Incept royalties as follows under the Second Amended Agreement: (i) consistent with the Prior Agreement, a royalty equal to a low single-digit percentage of net sales by us or our affiliates of products, devices, materials, or components thereof, or Licensed Products, including or covered by Original IP, excluding the Shape-Changing IP, in the Ophthalmic Field of Use; (ii) a royalty equal to a mid- 22 Table of Contents single-digit percentage of net sales by us or our affiliates of Licensed Products including or covered by Original IP, excluding the Shape-Changing IP, in the Additional Field of Use; and (iii) a royalty equal to a low single-digit percentage of net sales by us or our affiliates of Licensed Products including or covered by Incept IP or Joint IP in the field of drug delivery.
We and any of our sublicensees are obligated to pay Incept royalties as follows under the Second Amended Agreement: (i) consistent with the Prior Agreement, a royalty equal to a low single-digit percentage of net sales by us or our affiliates of products, devices, materials, or components thereof, or Licensed Products, including or covered by Original IP, excluding the Shape-Changing IP, in the Ophthalmic Field of Use; (ii) a royalty equal to a mid-single-digit percentage of net sales by us or our affiliates of Licensed Products including or covered by Original IP, excluding the Shape-Changing IP, in the Additional Field of Use; and (iii) a royalty equal to a low single-digit percentage of net sales by us or our affiliates of Licensed Products including or covered by Incept IP or Joint IP in the field of drug delivery.
Data Privacy Framework to rely on it as a valid data transfer mechanism for data transfers from the EU to the U.S. However, some privacy advocacy groups have already suggested that they will be challenging the EU-U.S. Data Privacy Framework. If these challenges are successful, they may not only impact the EU-U.S.
Data Privacy Framework to rely on it as a valid data transfer mechanism for data transfers from the European Union to the U.S. However, some privacy advocacy groups have already suggested that they will be challenging the EU-U.S. Data Privacy Framework. If these challenges are successful, they may not only impact the EU-U.S.
At any time during this 30-day period, or thereafter, the FDA may raise concerns or questions about the conduct of the trials as outlined in the IND and impose a clinical hold or partial clinical hold. In this case, the IND sponsor and the FDA must resolve any outstanding concerns before clinical trials can begin.
At any time during this 30-day period, or thereafter, the FDA 30 Table of Contents may raise concerns or questions about the conduct of the trials as outlined in the IND and impose a clinical hold or partial clinical hold. In this case, the IND sponsor and the FDA must resolve any outstanding concerns before clinical trials can begin.
Clinical Trials Outside the United States in Support of FDA Approval In connection with our clinical development program, we have trial sites outside the United States from time to time. When a foreign clinical trial is conducted under an IND, all IND requirements must be met unless waived.
Clinical Trials Outside the United States in Support of FDA Approval In connection with our clinical development program, we utilize trial sites outside the United States from time to time. When a foreign clinical trial is conducted under an IND, all IND requirements must be met unless waived.
Connecticut and Nevada have also passed similar laws regulating consumer health data, and more states are considering such legislation in 2024. These laws may impact our business activities, including our identification of research subjects, relationships with business partners and ultimately the marketing and distribution of our products.
Connecticut and Nevada have also passed similar laws regulating consumer health data, and more states are considering such legislation. These laws may impact our business activities, including our identification of research subjects, relationships with business partners and ultimately the marketing and distribution of our products.
This MA is close to the conditional MA as it is reserved to medicinal products to be approved for severe diseases or unmet medical needs and the applicant does not hold the complete data set legally required for the grant of a MA.
This MA is close to the conditional MA as it is reserved to medicinal products to be approved for severe diseases or unmet medical needs and the applicant does not hold the complete data set legally required for the grant of an MA.
If the FDA disagrees with the manufacturer’s determination and requires new 510(k) clearances or PMA application approvals for modifications to previously cleared products for which the manufacturer concluded that new clearances or approvals are unnecessary, the manufacturer may be required to cease marketing or distribution of the products or to recall the modified product until it obtains clearance or approval, and the manufacturer may be subject to significant regulatory fines or penalties.
If the FDA disagrees with the manufacturer’s determination and requires new 510(k) clearances or PMA application approvals for modifications to previously cleared products for which the manufacturer concluded that new clearances or approvals are unnecessary, the manufacturer may 45 Table of Contents be required to cease marketing or distribution of the products or to recall the modified product until it obtains clearance or approval, and the manufacturer may be subject to significant regulatory fines or penalties.
In addition, IND safety reports must be submitted to the FDA for any of the following: serious and unexpected suspected adverse reactions; findings from other studies or animal or in vitro testing that suggest a significant risk in humans exposed to the product candidate; and any clinically important increase in the occurrence of a serious suspected 30 Table of Contents adverse reaction over that listed in the protocol or investigator brochure.
In addition, IND safety reports must be submitted to the FDA for any of the following: serious and unexpected suspected adverse reactions; findings from other studies or animal or in vitro testing that suggest a significant risk in humans exposed to the product candidate; and any clinically important increase in the occurrence of a serious suspected adverse reaction over that listed in the protocol or investigator brochure.
Like the CCPA, these laws create obligations related to the processing of personal information, as well as special obligations for the processing of “sensitive” data, which includes health data in some cases. Some of the provisions of these laws may apply to our business activities.
Like the CCPA and CPRA, these laws create obligations related to the processing of personal information, as well as special obligations for the processing of “sensitive” data, which includes health data in some cases. Some of the provisions of these laws may apply to our business activities.
We hold worldwide exclusive commercial rights to the core technology underlying all of our product candidates in development and have not granted commercial rights to any marketing partners other than a license agreement and collaboration with AffaMed Therapeutics Limited, or AffaMed, for the development and commercialization of DEXTENZA and PAXTRAVA in certain geographies in Asia agreed to between the parties.
We hold worldwide exclusive commercial rights to the core technology underlying all of our product candidates in development and have not granted commercial rights to any marketing partners other than a license agreement and collaboration with AffaMed Therapeutics Limited, or AffaMed, for the development and commercialization of DEXTENZA and OTX-TIC in certain geographies in Asia agreed to between the parties.
Conditional Approval In particular circumstances, European Union legislation (Article 14–a Regulation (EC) No 726/2004 (as amended by Regulation (EU) 2019/5 and Regulation (EC) No 507/2006 on Conditional Marketing Authorizations for Medicinal Products for Human Use) enables sponsors to obtain a conditional marketing authorization prior to obtaining the comprehensive clinical data required for an application for a full marketing authorization.
Conditional Marketing Authorization In particular circumstances, EU legislation (Article 14–a Regulation (EC) No 726/2004 (as amended by Regulation (EU) 2019/5 and Regulation (EC) No 507/2006 on Conditional Marketing Authorizations for Medicinal Products for Human Use) enables sponsors to obtain a conditional marketing authorization prior to obtaining the comprehensive clinical data required for an application for a full marketing authorization.
Direct-to-consumer advertising of prescription medicines is prohibited across the European Union. Regulatory Data Protection in the European Union In the European Union, innovative medicinal products approved on the basis of a complete independent data package qualify for eight years of data exclusivity upon marketing authorization and an additional two years of market exclusivity pursuant to Directive 2001/83/EC.
Direct-to-consumer advertising of prescription medicines is prohibited across the European Union. 52 Table of Contents Regulatory Data Protection in the European Union In the European Union, innovative medicinal products approved on the basis of a complete independent data package qualify for eight years of data exclusivity upon marketing authorization and an additional two years of market exclusivity pursuant to Directive 2001/83/EC.
Glaucoma Program PAXTRAVA (travoprost intracameral hydrogel) Our product candidate PAXTRAVA is a bioresorbable hydrogel implant based on ELUTYX, incorporating travoprost, an FDA-approved PGA designed to lower elevated IOP, that is designed to be administered by a physician as an intracameral injection with an initial target duration of drug release of four to six months with a single treatment.
Glaucoma Program OTX-TIC (travoprost intracameral hydrogel) Our product candidate OTX-TIC is a bioresorbable hydrogel implant based on ELUTYX, incorporating travoprost, an FDA-approved PGA designed to lower elevated IOP, that is designed to be administered by a physician as an intracameral injection with an initial target duration of drug release of four to six months with a single treatment.
Under these procedures, before granting the MA, the EMA or the competent authorities of the European Union Member States make an assessment of the risk-benefit balance of the product on the basis of scientific criteria concerning its quality, safety and efficacy. Periods of Authorization and Renewals A marketing authorization has an initial validity for five years in principle.
Under these procedures, before granting the MA, the EMA or the competent authorities of the EU Member States make an assessment of the risk-benefit balance of the product on the basis of scientific criteria concerning its quality, safety and efficacy. Periods of Authorization and Renewals A marketing authorization has an initial validity for five years in principle.
Following the withdrawal of the United Kingdom from the European Union, the UK Data Protection Act 2018 applies to the processing of personal data that takes place in the United Kingdom and includes parallel obligations to those set forth by GDPR. 52 Table of Contents Additionally, in October 2022, President Biden signed an executive order to implement the EU-U.S.
Following the withdrawal of the United Kingdom from the European Union, the UK Data Protection Act 2018 applies to the processing of personal data that takes place in the United Kingdom and includes parallel obligations to those set forth by GDPR. Additionally, in October 2022, President Biden signed an executive order to implement the EU-U.S.
In this context, it should be noted that the European Union pharmaceutical legislation is currently undergoing a complete review process, in the context of the Pharmaceutical Strategy for Europe initiative, launched by the European Commission in November 2020.
In this context, it should be noted that the EU pharmaceutical legislation is currently undergoing a complete review process, in the context of the Pharmaceutical Strategy for Europe initiative, launched by the European Commission in November 2020.
Such conditional approvals may be granted for product candidates (including medicines designated as orphan medicinal products) if (1) the product candidate is intended for the treatment, prevention or medical diagnosis of seriously debilitating or life-threatening diseases; (2) the product candidate is intended to meet unmet medical needs of patients; (3) a marketing authorization may be granted prior to submission of comprehensive clinical data provided that the benefit of the immediate availability on the market of the medicinal product concerned outweighs the risk inherent in the fact that additional data are still required; (4) the risk-benefit balance of the product candidate is positive, and (5) it is likely that the sponsor will be in a position to provide the required comprehensive clinical trial data.
Such conditional approvals may be granted for product candidates (including medicines designated as orphan medicinal products) if (1) the product candidate is intended for the treatment, prevention or medical diagnosis of seriously debilitating or life-threatening diseases; (2) the product candidate is intended to meet unmet medical needs of patients; (3) the benefit of the immediate availability on the market of the medicinal product concerned outweighs the risk inherent in the fact that additional data are still required; (4) the risk-benefit balance of the product candidate is positive, and (5) it is likely that the sponsor will be in a position to provide the required comprehensive clinical trial data.
Phase 1 clinical development We submitted an IND for PAXTRAVA in February 2018 and have completed a prospective, multi-center, open-label, dose-escalation, proof-of-concept Phase 1 clinical trial of PAXTRAVA in the United States that we initiated in the second quarter of 2018 for the treatment of subjects with moderate to severe glaucoma or OHT.
Phase 1 Clinical Development We submitted an IND for OTX-TIC in February 2018 and have completed a prospective, multi-center, open-label, dose-escalation, proof-of-concept Phase 1 clinical trial of OTX-TIC in the United States that we initiated in the second quarter of 2018 for the treatment of subjects with moderate to severe glaucoma or OHT.
We also own two U.S. patents that cover this product with current expiration dates in 2036 and 2037, and a pending U.S. patent application. DEXTENZA (dexamethasone ophthalmic insert) 0.4 mg for the treatment of allergic conjunctivitis We have licenses to U.S. patents, and certain foreign counterparts, with current expiration dates in 2030 that cover this product.
We also own two U.S. patents that cover this product with current expiration dates in 2036 and 2037, and a pending U.S. patent application. 24 Table of Contents DEXTENZA (dexamethasone ophthalmic insert) 0.4 mg for the treatment of allergic conjunctivitis We have licenses to U.S. patents, and certain foreign counterparts, with current expiration dates in 2030 that cover this product.
Typically, an RTF will be based on administrative incompleteness, such as clear omission of information or sections of required information; scientific incompleteness, such as omission of critical data, information or analyses needed to evaluate safety and efficacy or provide adequate directions for use; or inadequate content, presentation, or organization of information such that substantive and meaningful review is precluded.
Typically, an RTF will be based on administrative incompleteness, such as clear omission of information or sections of required information; scientific incompleteness, 36 Table of Contents such as omission of critical data, information or analyses needed to evaluate safety and efficacy or provide adequate directions for use; or inadequate content, presentation, or organization of information such that substantive and meaningful review is precluded.
We received an agreement letter regarding the first SPA agreement modification from the FDA on January 22, 2024. This first SPA agreement modification enabled us to include in the trial treatment-naïve wet AMD subjects with visual acuity of approximately 20/80 or better at the initial screening visit.
We received an agreement letter regarding the first SPA agreement modification from the FDA on January 22, 2024. This first SPA agreement modification enabled us to include 9 Table of Contents in the trial treatment-naïve wet AMD subjects with visual acuity of approximately 20/80 or better at the initial screening visit.
Intravitreal Hydrogels We are engaged in the clinical development of our hydrogel administered via intravitreal injection to address the large and growing markets for diseases and conditions of the back of the eye. Our intravitreal hydrogel product candidates, such as AXPAXLI, consist of a PEG-based hydrogel, which contains embedded micronized particles of active drug.
Intravitreal Hydrogels We are engaged in the clinical development of our hydrogel administered via intravitreal injection to address the large and growing markets for diseases and conditions of the back of the eye. Our intravitreal hydrogel product candidates, such as AXPAXLI, consist of a PEG-based hydrogel, which contains embedded micronized particles of 19 Table of Contents active drug.
This three-year exclusivity period often protects changes to a previously approved drug product, such as new indications, dosage forms, route of administration or combination of ingredients. Three-year exclusivity would be available for a drug product that contains a previously approved active 38 Table of Contents moiety, provided the statutory requirement for a new clinical investigation is satisfied.
This three-year exclusivity period often protects changes to a previously approved drug product, such as new indications, dosage forms, route of administration or combination of ingredients. Three-year exclusivity would be available for a drug product that contains a previously approved active moiety, provided the statutory requirement for a new clinical investigation is satisfied.
Although SPCs are available throughout the European Union, sponsors must apply on a country-by-country basis. Similar patent term extension rights exist in certain other foreign jurisdictions outside the European Union.
Although SPCs are available throughout the European Union, sponsors must apply on a country-by-country basis, and SPCs are valid on a country-by-country basis. Similar patent term extension rights exist in certain other foreign jurisdictions outside the European Union.
The Ocular Therapeutix Approach Our Hydrogel-Based Formulation Technology ELUTYX We apply our expertise with ELUTYX to the development of products for local programmed-release of known, FDA-approved therapeutic agents for a variety of ophthalmic diseases and conditions and to ophthalmic wound closure. ELUTYX is based on the use of a proprietary form of polyethylene glycol, or PEG.
Our Hydrogel-Based Formulation Technology ELUTYX We apply our expertise with ELUTYX to the development of products for local programmed-release of known, FDA-approved therapeutic agents for a variety of ophthalmic diseases and conditions and to ophthalmic wound closure. ELUTYX is based on the use of a proprietary form of polyethylene glycol, or PEG.
In these countries, pricing negotiations with governmental authorities can take considerable time after the receipt of marketing approval for a product. To obtain reimbursement or pricing approval in some countries, pharmaceutical firms may be required to conduct a clinical trial that compares the cost-effectiveness of the product to other available therapies.
In these countries, pricing negotiations with governmental authorities can take considerable time after the receipt of marketing 53 Table of Contents approval for a product. To obtain reimbursement or pricing approval in some countries, pharmaceutical firms may be required to conduct a clinical trial that compares the cost-effectiveness of the product to other available therapies.
In the Phase 1 clinical trial, at least one subject in each of the four cohorts receiving PAXTRAVA were observed to experience a mean change in IOP from baseline as measured at 8:00 am, 10:00 a.m. and 4:00 p.m. as early as two days following injection.
In the Phase 1 clinical trial, at least one subject in each of the four cohorts receiving OTX-TIC were observed to experience a mean change in IOP from baseline as measured at 8:00 am, 10:00 a.m. and 4:00 p.m. as early as two days following injection.
In return, we agreed to grant AffaMed exclusive rights to develop and commercialize DEXTENZA for the treatment of post-surgical inflammation and pain following ophthalmic surgery and ocular itching in patients with allergic conjunctivitis, and PAXTRAVA for the reduction of elevated IOP in patients with primary OAG or OHT in specified Asian markets.
In return, we agreed to grant AffaMed exclusive rights to develop and commercialize DEXTENZA for the treatment of post-surgical inflammation and pain following ophthalmic surgery and ocular itching in patients with allergic conjunctivitis, and OTX-TIC for the reduction of elevated IOP in patients with primary OAG or OHT in specified Asian markets.
We rely on patent protection, trade secrets, know-how, continuing technological innovation and in-licensing opportunities to develop and maintain our proprietary position. 20 Table of Contents We have issued patents and/or patent applications pending for all of our commercial products and product candidates, as well as trade secrets to protect proprietary manufacturing processes.
We rely on patent protection, trade secrets, know-how, continuing technological innovation and in-licensing opportunities to develop and maintain our proprietary position. We have issued patents and/or patent applications pending for all of our commercial products and product candidates, as well as trade secrets to protect proprietary manufacturing processes.
An agreement may not be changed by the sponsor or FDA after the trial begins, except with the written agreement of the sponsor and FDA, or if the director of the FDA reviewing division determines that “a substantial scientific issue essential to determining the safety or effectiveness of the investigational product was identified after the testing began.
An agreement may not be changed by the sponsor or FDA after the trial begins, except with the written agreement of the sponsor and FDA, or if the director of the FDA reviewing division determines that “a substantial scientific issue essential to determining the safety or 34 Table of Contents effectiveness of the investigational product was identified after the testing began.
Pursuant to the Food and Drug Administration Safety and Innovation Act of 2012, or FDASIA, the FDA must send a PREA Non-Compliance letter to sponsors who have failed to submit their pediatric assessments required under PREA, have failed to seek or obtain a deferral or deferral extension or have failed to request approval for a required pediatric formulation.
Pursuant to the Food and Drug Administration Safety and Innovation Act of 2012, or FDASIA, the FDA must send a PREA Non-Compliance letter to sponsors who have failed to 35 Table of Contents submit their pediatric assessments required under PREA, have failed to seek or obtain a deferral or deferral extension or have failed to request approval for a required pediatric formulation.
Any country that has price controls or reimbursement limitations for drug products may not allow favorable reimbursement and pricing arrangements. Healthcare Law and Regulation Healthcare providers, physicians and third-party payors play a primary role in the recommendation and prescription of drug products that are granted marketing approval.
Any country that has price controls or reimbursement limitations for drug products may not allow favorable reimbursement and pricing arrangements. 57 Table of Contents Healthcare Law and Regulation Healthcare providers, physicians and third-party payors play a primary role in the recommendation and prescription of drug products that are granted marketing approval.
The conditions for pediatric exclusivity include the FDA’s determination that information relating to the use of a new product in the pediatric population may produce health benefits in that population, the FDA making a written request for pediatric clinical trials, and the sponsor agreeing to perform, and reporting on, the requested clinical trials within the statutory timeframe.
The conditions for pediatric exclusivity include the FDA’s 43 Table of Contents determination that information relating to the use of a new product in the pediatric population may produce health benefits in that population, the FDA making a written request for pediatric clinical trials, and the sponsor agreeing to perform, and reporting on, the requested clinical trials within the statutory timeframe.
Most 510(k)s do not require clinical data for clearance, but the FDA may request such data. 41 Table of Contents The FDA seeks to review and act on a 510(k) within 90 days of submission, but it may take longer if the agency finds that it requires more information to review the 510(k).
Most 510(k)s do not require clinical data for clearance, but the FDA may request such data. The FDA seeks to review and act on a 510(k) within 90 days of submission, but it may take longer if the agency finds that it requires more information to review the 510(k).
European Union member states may approve a specific price for a drug product or it may instead adopt a system of direct or indirect controls on the profitability of the company placing the drug product on the market. Other member states allow companies to fix their own prices for drug products, but monitor and control company profits.
EU Member States may approve a specific price for a drug product or it may instead adopt a system of direct or indirect controls on the profitability of the company placing the drug product on the market. Other member states allow companies to fix their own prices for drug products, but monitor and control company profits.
Pediatric Exclusivity If a sponsor obtains a marketing authorization in all European Union Member States, or a marketing authorization granted in the centralized procedure by the European Commission, and the study results for the pediatric population are 49 Table of Contents included in the product information, even when negative, the medicine is then eligible for an additional six-month period of qualifying patent protection through extension of the term of the Supplementary Protection Certificate, or SPC, or alternatively a one year extension of the regulatory market exclusivity from ten to eleven years, as selected by the marketing authorization holder.
Pediatric Exclusivity If a sponsor obtains a marketing authorization in all EU Member States, or a marketing authorization granted in the centralized procedure by the European Commission, and the study results for the pediatric population are included in the product information, even when negative, the medicine is then eligible for an additional six-month period of qualifying patent protection through extension of the term of the Supplementary Protection Certificate, or SPC, or alternatively a one year extension of the regulatory market exclusivity from ten to eleven years, as selected by the marketing authorization holder.
There is no obligation for a sponsor to make its investigational products available for expanded access; however, as required by amendments to the FDCA included in the 21st Century Cures Act, or the Cures Act, passed in 2016, if a 28 Table of Contents sponsor has a policy regarding how it responds to expanded access requests with respect to product candidates in development to treat serious diseases or conditions, it must make that policy publicly available.
There is no obligation for a sponsor to make its investigational products available for expanded access; however, as required by amendments to the FDCA included in the 21st Century Cures Act, or the Cures Act, passed in 2016, if a sponsor has a policy regarding how it responds to expanded access requests with respect to product candidates in development to treat serious diseases or conditions, it must make that policy publicly available.
A company’s designation of a clinical trial as being of a particular phase is not necessarily indicative that the study will be sufficient to satisfy the FDA requirements of that phase because this determination cannot be made until the protocol and data have been submitted to and reviewed by the FDA.
A company’s designation of a clinical trial as being of a particular phase is not necessarily indicative that the study will be sufficient to satisfy the FDA requirements of that 32 Table of Contents phase because this determination cannot be made until the protocol and data have been submitted to and reviewed by the FDA.
The decentralized procedure provides for approval by one or more other, or concerned, member states of an assessment of an application performed by one member state designated by the sponsor, known as the reference member state.
The decentralized procedure provides for approval by one or more other, or concerned, EU Member States of an assessment of an application performed by one member state designated by the sponsor, known as the reference member state, or RMS.
In December 2023, we submitted a first SPA agreement modification to the FDA to broaden the inclusion criteria for subjects in the SOL-1 trial and to reflect our intention to evaluate a single optimized dose of AXPAXLI with a drug load of 450 µg of a more soluble form of axitinib in the trial.
In December 2023, we submitted a first SPA agreement modification to the FDA to broaden the inclusion criteria for subjects in the SOL-1 trial and to reflect our intention to evaluate a single optimized dose of AXPAXLI 450 μg of a more soluble form of axitinib in the trial.
These results align with our expectation that we would see a reactivation of disease in some subjects, which we believe indicates that AXPAXLI continues to function as designed with axitinib concentrations beginning to fall below therapeutic levels after the hydrogel bioresorbs.
These results align with our expectation that we would see a reactivation of 12 Table of Contents disease in some subjects, which we believe indicates that AXPAXLI continues to function as designed with axitinib concentrations beginning to fall below therapeutic levels after the hydrogel bioresorbs.
Certain of our U.S. patents and applications, and their foreign counterparts, are owned by us and other U.S. patents and applications, and their foreign counterparts have been in-licensed from Incept. The existence of patent applications does not guarantee that a patent will issue, or that any patent that does issue will cover the product or product candidate.
Certain of our U.S. patents and applications, and their foreign counterparts, are owned by us and other U.S. patents and applications, and their foreign counterparts have been in-licensed from Incept. 23 Table of Contents The existence of patent applications does not guarantee that a patent will issue, or that any patent that does issue will cover the product or product candidate.
AffaMed has the right to terminate the AffaMed License Agreement at any time following the completion of a Phase 3 clinical trial to evaluate PAXTRAVA. Competition The biotechnology and pharmaceutical industries are characterized by rapidly advancing technologies, intense competition and a strong emphasis on proprietary products.
AffaMed has the right to terminate the AffaMed License Agreement at any time following the completion of a Phase 3 clinical trial to evaluate OTX-TIC. Competition The biotechnology and pharmaceutical industries are characterized by rapidly advancing technologies, intense competition and a strong emphasis on proprietary products.
If the FDA’s evaluations are not favorable, the FDA will deny approval of the PMA application or issue a not approvable letter. The PMA application process, including the 42 Table of Contents gathering of clinical and nonclinical data and the submission to and review by the FDA, can take several years, and the process can be expensive and uncertain.
If the FDA’s evaluations are not favorable, the FDA will deny approval of the PMA application or issue a not approvable letter. The PMA application process, including the gathering of clinical and nonclinical data and the submission to and review by the FDA, can take several years, and the process can be expensive and uncertain.
To support the advancement of our employees, we offer training and development programs encouraging advancement from within and continue to fill our team with strong and experienced 57 Table of Contents management talent. We leverage both formal and informal programs to identify, foster, and retain top talent at both the corporate and operating unit level.
To support the advancement of our employees, we offer training and development programs encouraging advancement from within and continue to fill our team with strong and experienced management talent. We leverage both formal and informal programs to identify, foster, and retain top talent at both the corporate and operating unit level.
We retain the right to develop and commercialize DEXTENZA and PAXTRAVA in all other global markets. Sales, Marketing and Distribution We generally expect to retain commercial rights in the United States to any of our product candidates for which we may receive marketing approvals and which we believe we can successfully commercialize.
We retain the right to develop and commercialize DEXTENZA and OTX-TIC in all other global markets. Sales, Marketing and Distribution We generally expect to retain commercial rights in the United States to any of our product candidates for which we may receive marketing approvals and which we believe we can successfully commercialize.
As of December 31, 2024, we owned or exclusively licensed in certain fields of use over 300 issued U.S. patents, pending U.S. patent applications, issued foreign patents and pending foreign patent applications.
As of December 31, 2025, we owned or exclusively licensed in certain fields of use over 300 issued U.S. patents, pending U.S. patent applications, issued foreign patents and pending foreign patent applications.
There can be no guarantee, however, that any of the remaining milestones will be achieved. We are also entitled to receive tiered, 23 Table of Contents escalating royalties on the net sales of the AffaMed Licensed Products ranging from a low-teen to low-twenties percentage.
There can be no guarantee, however, that any of the remaining milestones will be achieved. We are also entitled to receive tiered, escalating royalties on the net sales of the AffaMed Licensed Products ranging from a low-teen to low-twenties percentage.
OMIDRIA, purchased by Rayner Surgical Group Limited, is a prescription medication used during cataract 25 Table of Contents surgery. According to the OMIDRIA website, this product helps the black part in the center of the eye (pupil) stay open (dilated) during cataract surgery and decreases eye pain after surgery.
OMIDRIA, purchased by Rayner Surgical Group Limited, is a prescription medication used during cataract surgery. According to the OMIDRIA website, this product helps the black part in the center of the eye (pupil) stay open (dilated) during cataract surgery and decreases eye pain after surgery.
An approval letter, on the other hand, authorizes commercial marketing of the product with specific prescribing information for specific indications. That is, the approval will be limited to the conditions of use (e.g., patient population, indication) described in the FDA-approved labeling.
An approval letter, on the other hand, authorizes commercial marketing of the product with specific prescribing information for specific indications. That is, the approval will be limited to the conditions of use (e.g., patient 38 Table of Contents population, indication) described in the FDA-approved labeling.
Beyond streamlining the process, the new Regulation includes a single set of documents to be prepared and submitted for the application as well as simplified reporting procedures for clinical trial sponsors, and a harmonized procedure for the assessment of applications for clinical trials, which is divided in two parts.
Beyond streamlining the process, the CTR includes a single set of documents to be prepared and submitted for the application as well as simplified reporting procedures for clinical trial sponsors, and a harmonized procedure for the assessment of applications for clinical trials, which is divided in two parts.
The timelines for the centralized procedure described above also apply with respect to the review by the CHMP of applications for a conditional marketing authorization, but applicants can also request EMA to conduct an accelerated assessment, for instance in cases of unmet medical needs.
The timelines for the centralized procedure described above also apply with respect to the review by the CHMP of applications for a 51 Table of Contents conditional marketing authorization, but applicants can also request EMA to conduct an accelerated assessment, for instance in cases of unmet medical needs.
The first time a subject is observed to have lost 15 or more ETDRS letters in BCVA in the study eye due to wet AMD at any time in the trial would be considered as having met the endpoint as a treatment failure.
The first time a subject is observed to have lost 15 or more ETDRS letters in BCVA in the study eye due to wet AMD at any time up to Week 36 in the trial would be considered as having met the endpoint as a treatment failure.
DEXTENZA for the treatment of ocular itching associated with allergic conjunctivitis also represents our first indication approved to be administered in a physician’s office during a routine, non-surgical appointment. We commercially launched DEXTENZA for the treatment of ocular itching associated with allergic conjunctivitis in the first quarter of 2022.
DEXTENZA for the treatment of ocular itching associated with allergic conjunctivitis 21 Table of Contents also represents our first indication approved to be administered in a physician’s office during a routine, non-surgical appointment. We commercially launched DEXTENZA for the treatment of ocular itching associated with allergic conjunctivitis in the first quarter of 2022.
These plans are meant to encourage enrollment of more diverse patient populations in late-stage clinical trials of FDA-regulated products. In June 2024, as mandated by FDORA, the FDA issued draft guidance outlining the general requirements for diversity action plans.
These plans are meant to encourage the enrollment of more diverse patient populations in late-stage clinical trials of FDA-regulated products. In June 2024, as mandated by FDORA, the FDA issued draft guidance outlining the general requirements for DAPs.

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Item 1C. Cybersecurity

Cybersecurity — threats and controls disclosure

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Biggest changeCollectively, the members of our Cybersecurity Committee have notable experience in managing information security, possess the education and skills to fulfill these duties, and attend periodic trainings as necessary. 104 Table of Contents In an effort to deter and detect cyber threats, we provide all employees, including part-time and temporary employees, with periodic training, including training related to data protection, cybersecurity and incident response, and prevention and compliance, which covers timely and relevant topics, including social engineering, phishing, password protection, confidential data protection, asset use and mobile security, and educates employees on the importance of reporting all incidents immediately.
Biggest changeIn an effort to deter and detect cyber threats, we provide all employees, including part-time and temporary employees, with periodic security-awareness training, including training related to cybersecurity threats, which covers timely and relevant topics such as, but not limited to, threats from artificial intelligence, social engineering, phishing, password protection and mobile security, and educates employees on the importance of reporting all incidents immediately.
The Audit Committee receives periodic updates from management regarding cybersecurity matters and is notified between such updates regarding significant new cybersecurity threats or incidents. Our management team is responsible for day-to-day assessment and management of cybersecurity risks.
The Audit Committee receives periodic updates from management regarding cybersecurity matters and is notified between such updates regarding significant new cybersecurity threats or incidents. 111 Table of Contents Our management team is responsible for day-to-day assessment and management of cybersecurity risks.
Our CFO and COO has more than ten years of experience managing information technology teams of operating companies in the biotechnology industry.
Our CFO and COO has more than eleven years of experience managing information technology teams of operating companies in the biotechnology industry.
Our cybersecurity program is built upon, and we periodically assess our processes against, the National Institute of Standards and Technology, or NIST, Cybersecurity Framework Special Publication 800-53, and our incident response capabilities align with NIST 800-61, revision 2, or collectively, the NIST Framework.
Our cybersecurity program is built upon, and we periodically assess our processes against, the National Institute of Standards and Technology, or NIST, Cybersecurity Framework (CSF) 2.0, or the NIST Framework.
The Executive Director IT and Cybersecurity has over ten years of offensive and defensive cybersecurity experience with departments of the U.S. government, international alliances and small to large biopharmaceutical companies.
Our CFO and COO has implemented and maintains a formal cybersecurity program which is led by our Director of IT Cybersecurity who has over fifteen years of offensive and defensive cybersecurity experience with departments of the U.S. government, international alliances and small to large biopharmaceutical companies.
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Our CFO and COO leads a cross-functional Cybersecurity Committee, consisting of executive-level leaders and other management-level individuals with the requisite skills and education, including our Executive Director IT and Cybersecurity, that assists the CFO and COO with carrying out these duties.
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We collaborate with a third party that provides virtual Chief Information Security Officer, or Virtual CISO, services to further support our cybersecurity program. Collectively, the individuals involved in our cybersecurity team and the Virtual CISO have notable experience in managing information security, possess the education and skills to fulfill these duties, and attend periodic trainings as necessary .
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During our CFO and COO’s temporary medical leave of absence, our Director of IT Cybersecurity reports to our management team through our interim CFO, who has 10 years of experience implementing and managing enterprise resource planning, or ERP, systems and cybersecurity policies in the biotechnology industry.

Item 2. Properties

Properties — owned and leased real estate

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Biggest changeItem 2. Properties Our facilities consist of leased office space, laboratory space and manufacturing facilities in Bedford, Massachusetts. We occupy approximately 91,000 square feet of space. The lease for approximately 71,000 square feet of this space expires in July 2027, and the lease for approximately 20,000 square feet of this space, which includes our manufacturing facility, expires in July 2028.
Biggest changeItem 2. Properties Our facilities consist of leased office space, laboratory space and manufacturing facilities. Effective January 1, 2026, we entered into a sublease for approximately 24,000 square feet of office space located at 14 Crosby Drive in Bedford, Massachusetts. The lease commenced on January 1, 2026 and will expire on March 30, 2031.
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We expect this location will become our company headquarters.
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A summary of our leased properties is as follows: ​ ​ ​ ​ ​ ​ ​ ​ Location ​ Approximate Square Feet ​ Use ​ Lease Expiration Bedford, MA ​ 71,000 ​ Manufacturing, laboratories, warehouse, office space ​ 2027 Bedford, MA ​ 24,000 ​ Office space (future corporate headquarters) ​ 2031 Bedford, MA ​ 20,000 ​ Manufacturing, warehouse, office space ​ 2028 ​ We hold options to extend the lease for approximately 71,000 square feet in Bedford, Massachusetts for a total of up to 10 additional years.

Item 3. Legal Proceedings

Legal Proceedings — active lawsuits and investigations

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Biggest changeWe are not presently a party to any material legal proceedings, nor to the knowledge of management are any material legal proceedings threatened against us. ​
Biggest changeWe are not presently a party to any material legal proceedings, nor to the knowledge of management are any material legal proceedings threatened against us. ​ Item 4. Mine Safety Disclosures Not Applicable. ​ ​ 112 Table of Contents ​ PART II

Item 5. Market for Registrant's Common Equity

Market for Common Equity — stock, dividends, buybacks

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Biggest changePurchase of Equity Securities We did not purchase any of our registered equity securities during the period covered by this Annual Report on Form 10-K. ​
Biggest changePurchase of Equity Securities We did not purchase any of our registered equity securities during the period covered by this Annual Report on Form 10-K. ​ 113 Table of Contents Stock Performance Graph The following graph and chart compares the cumulative annual stockholder return on our common stock over the period commencing December 31, 2020 and ending on December 31, 2025, to that of the total return for the NASDAQ Composite Index and the NASDAQ Biotechnology Index, assuming an investment of $100 on December 31, 2020.
Recent Sales of Unregistered Securities We did not sell any shares of our common stock, shares of our preferred stock or warrants to purchase shares of our stock, or grant any stock options or restricted stock awards, during the year ended December 31, 2024 that were not registered under the Securities Act of 1933, as amended, or the Securities Act, and that have not otherwise been described in a Quarterly Report on Form 10-Q or a Current Report on Form 8-K.
Recent Sales of Unregistered Securities We did not sell any shares of our common stock, shares of our preferred stock or warrants to purchase shares of our stock, or grant any stock options or restricted stock awards, during the year ended December 31, 2025 that were not registered under the Securities Act of 1933, as amended, or the Securities Act, and that have not otherwise been described in a Quarterly Report on Form 10-Q or a Current Report on Form 8-K.
Securities Authorized for Issuance under Equity Compensation Plans The information required by this item will be set forth in the definitive proxy statement we will file in connection with our 2025 Annual Meeting of Stockholders and is incorporated by reference herein.
Securities Authorized for Issuance under Equity Compensation Plans The information required by this item will be set forth in the definitive proxy statement we will file in connection with our 2026 Annual Meeting of Stockholders and is incorporated by reference herein.
Item 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer’s Purchases of Equity Securities Our common stock has been publicly traded on the Nasdaq Global Market under the symbol “OCUL” since July 25, 2014. Holders As of February 27, 2025, there were approximately 10 holders of record of our common stock.
Item 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer’s Purchases of Equity Securities Our common stock has been publicly traded on the Nasdaq Global Market under the symbol “OCUL” since July 25, 2014. Holders As of February 2, 2026, there were approximately 10 holders of record of our common stock.
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In calculating cumulative total annual stockholder return, reinvestment of dividends, if any, is assumed. The indices are included for comparative purposes only. They do not necessarily reflect management’s opinion that such indices are an appropriate measure of the relative performance of our common stock and are not intended to forecast or be indicative of future performance of our common stock.
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The following graph and related information shall not be deemed “soliciting material” or be “filed” with the SEC, nor shall such information be incorporated by reference in any of our filings under the Securities Act, or the Exchange Act, whether made before or after the date hereof and irrespective of any general incorporation language in any such filing. ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ 12/31/2020 ​ 12/31/2021 ​ 12/30/2022 ​ 12/29/2023 ​ 12/31/2024 ​ 12/31/2025 Ocular Therapeutix $ 100.00 ​ ​ 33.67 ​ ​ 13.57 ​ ​ 21.55 ​ ​ 41.26 ​ ​ 58.65 Nasdaq Composite $ 100.00 ​ ​ 121.39 ​ ​ 81.21 ​ ​ 116.47 ​ ​ 149.83 ​ ​ 180.33 Nasdaq Biotechnology Index $ 100.00 ​ ​ 99.37 ​ ​ 88.53 ​ ​ 91.84 ​ ​ 90.58 ​ ​ 119.92 ​ Item 6. [Reserved.] ​ ​

Item 7. Management's Discussion & Analysis

Management's Discussion & Analysis (MD&A) — revenue / margin commentary

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Biggest changeIn August 2023, we also extinguished our obligations under the MidCap Credit Facility, resulting in a non-cash loss on extinguishment. 111 Table of Contents Results of Operations The following table summarizes our results of operations for the years ended December 31, 2024, 2023 and 2022: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Year Ended ​ ​ ​ ​ ​ ​ ​ ​ December 31, ​ Increase (Decrease) ​ 2024 2023 ​ 2022 2024 - 2023 2023 - 2022 ​ ​ (in thousands) Revenue: ​ ​ ​ ​ ​ ​ ​ ​ ​ Product revenue, net ​ $ 63,461 ​ $ 57,870 ​ $ 50,457 ​ $ 5,591 ​ $ 7,413 Collaboration revenue ​ 262 ​ 573 ​ 1,037 ​ (311) ​ (464) Total revenue, net ​ 63,723 ​ 58,443 ​ 51,494 ​ 5,280 ​ 6,949 Costs and operating expenses: ​ ​ ​ ​ ​ ​ ​ ​ Cost of product revenue ​ 5,626 ​ 5,281 ​ 4,540 ​ 345 ​ ​ 741 Research and development ​ 127,635 ​ 61,055 ​ 53,462 ​ 66,580 ​ ​ 7,593 Selling and marketing ​ 41,590 ​ 40,549 ​ 39,922 ​ 1,041 ​ ​ 627 General and administrative ​ 60,653 ​ 33,940 ​ 32,224 ​ 26,713 ​ ​ 1,716 Total costs and operating expenses ​ 235,504 ​ 140,825 ​ 130,148 ​ 94,679 ​ 10,677 Loss from operations ​ (171,781) ​ (82,382) ​ (78,654) ​ (89,399) ​ (3,728) Other income (expense): ​ ​ ​ ​ ​ ​ ​ ​ Interest income ​ 20,282 ​ 3,983 ​ 798 ​ 16,299 ​ ​ 3,185 Interest expense ​ (13,577) ​ (11,338) ​ (7,022) ​ (2,239) ​ ​ (4,316) Change in fair value of derivative liabilities ​ ​ (480) ​ (5,188) ​ 13,841 ​ ​ 4,708 ​ ​ (19,029) Gains and losses on extinguishment of debt, net ​ ​ (27,950) ​ 14,190 ​ — ​ ​ (42,140) ​ ​ 14,190 Other expense, net ​ — ​ (1) ​ (1) ​ 1 ​ ​ — Total other income, net ​ (21,725) ​ 1,646 ​ 7,616 ​ (23,371) ​ (5,970) Net loss ​ $ (193,506) ​ $ (80,736) ​ $ (71,038) ​ $ (112,770) ​ $ (9,698) ​ Product Revenue, net Our product revenue, net was $63.5 million and $57.9 million for the years ended December 31, 2024 and 2023, respectively, reflecting an increase of $5.6 million year-over-year.
Biggest changeIn August 2023, we also extinguished our obligations under the MidCap Credit Facility, resulting in a non-cash loss on extinguishment. 119 Table of Contents Results of Operations The following table summarizes our results of operations for the years ended December 31, 2025, 2024 and 2023: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Year Ended December 31, ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Increase (Decrease) ​ ​ ​ ​ 2025 ​ ​ ​ 2024 ​ ​ ​ 2023 ​ ​ ​ 2025 - 2024 ​ ​ ​ 2024 - 2023 Revenue: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Product revenue, net ​ $ 51,823 ​ $ 63,461 ​ $ 57,870 $ (11,638) ​ $ 5,591 Collaboration revenue ​ ​ 128 ​ ​ 262 ​ ​ 573 ​ ​ (134) ​ ​ (311) Total revenue, net ​ 51,951 ​ 63,723 ​ 58,443 ​ (11,772) ​ 5,280 Costs and operating expenses: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Cost of product revenue ​ ​ 6,574 ​ ​ 5,626 ​ ​ 5,281 ​ ​ 948 ​ ​ 345 Research and development ​ ​ 197,096 ​ ​ 127,635 ​ ​ 61,055 ​ ​ 69,461 ​ ​ 66,580 Selling and marketing ​ ​ 53,922 ​ ​ 41,590 ​ ​ 40,549 ​ ​ 12,332 ​ ​ 1,041 General and administrative ​ ​ 64,376 ​ ​ 60,653 ​ ​ 33,940 ​ ​ 3,723 ​ ​ 26,713 Total costs and operating expenses ​ 321,968 ​ 235,504 ​ 140,825 ​ 86,464 ​ 94,679 Loss from operations ​ (270,017) ​ (171,781) ​ (82,382) ​ (98,236) ​ (89,399) Other income (expense): ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Interest income ​ ​ 18,355 ​ ​ 20,282 ​ ​ 3,983 ​ ​ (1,927) ​ ​ 16,299 Interest expense ​ ​ (11,835) ​ ​ (13,577) ​ ​ (11,338) ​ ​ 1,742 ​ ​ (2,239) Change in fair value of derivative liabilities ​ ​ (2,471) ​ ​ (480) ​ ​ (5,188) ​ ​ (1,991) ​ ​ 4,708 Gains and (losses) on extinguishment of debt, net ​ ​ — ​ ​ (27,950) ​ ​ 14,190 ​ ​ 27,950 ​ ​ (42,140) Other gains (expenses) ​ ​ 29 ​ ​ — ​ ​ (1) ​ ​ 29 ​ ​ 1 Total other income (expense), net ​ 4,078 ​ (21,725) ​ 1,646 ​ 25,803 ​ (23,371) Net loss ​ $ (265,939) ​ $ (193,506) ​ $ (80,736) ​ $ (72,433) ​ $ (112,770) ​ Product Revenue, net Our product revenue, net was $51.8 million and $63.5 million for the years ended December 31, 2025 and 2024, respectively, reflecting a decrease of $11.6 million year-over-year.
In February 2024, we sold 32,413,560 shares of our common stock at $7.52 per share and, in lieu of common stock to certain investors, pre-funded warrants to purchase up to an aggregate of 10,805,957 shares of our common stock at a price of $7.519 per pre-funded warrant for total net proceeds of approximately $316.4 million, after deducting placement agent fees and other offering expenses, in the 2024 Private Placement.
In February 2024, we sold 32,413,560 shares of our common stock at $7.52 per share and, in lieu of common stock to certain investors, pre-funded warrants to purchase up to an aggregate of 10,805,957 shares of our common stock at a price of $7.519 per pre-funded warrant for total net proceeds of approximately $316.4 million, after deducting placement agent fees and other offering expenses, in a private placement.
Research and Development Expenses Research and development expenses consist primarily of costs incurred for the development of our product candidates, which include: ● expenses incurred in connection with the clinical trials of our product candidates, including with the investigative sites that conduct our clinical trials and under agreements with contract research organizations, or CROs; ● employee-related expenses, including salaries, related benefits and payroll taxes, travel and stock-based compensation expense for employees engaged in research and development, clinical and regulatory and other related functions; ● expenses relating to regulatory activities, including filing fees paid to the FDA for our submissions for product approvals; ● expenses associated with developing our pre-commercial manufacturing capabilities and manufacturing clinical study materials; 109 Table of Contents ● ongoing research and development activities relating to our core bioresorbable hydrogel technology and improvements to this technology; ● facilities, depreciation and other expenses, which include direct and allocated expenses for rent and maintenance of facilities, insurance and supplies; ● costs relating to the supply and manufacturing of product inventory, prior to approval by the FDA or other regulatory agencies of our products; and ● expenses associated with preclinical development activities.
Research and Development Expenses Research and development expenses consist primarily of costs incurred for the development of our product candidates, which include: ● expenses incurred in connection with the clinical trials of our product candidates, including with the investigative sites that conduct our clinical trials and under agreements with contract research organizations, or CROs; ● employee-related expenses, including salaries, related benefits and payroll taxes, travel and stock-based compensation expense for employees engaged in research and development, clinical and regulatory and other related functions; ● expenses relating to regulatory activities, including filing fees paid to the FDA for our submissions for product approvals; ● expenses associated with developing our pre-commercial manufacturing capabilities and manufacturing clinical study materials; ● ongoing research and development activities relating to our core bioresorbable hydrogel technology and improvements to this technology; ● facilities, depreciation and other expenses, which include direct and allocated expenses for rent and maintenance of facilities, insurance and supplies; ● costs relating to the supply and manufacturing of product inventory, prior to approval by the FDA or other regulatory agencies of our products; and 117 Table of Contents ● expenses associated with preclinical development activities.
Commercial Our net product revenue is generated from the sale of DEXTENZA to specialty distributors, or SDs, for resale to certain ambulatory surgery centers, or ASCs, certain hospital outpatient departments, or HOPDs, and certain physicians’ offices, and from the direct sale by us to ASCs and physicians’ offices.
Commercial Our net product revenue is generated from the sale of DEXTENZA to specialty distributors, or SDs, for resale to certain ambulatory surgery centers, or ASCs, certain hospital outpatient departments, or HOPDs, and certain physicians’ offices, and from the direct sale by us to ASCs and physicians’ offices, or Direct Sales.
Future payments of interest under the Barings Credit Agreement depends on the level of the Secured Overnight Financing Rate, or SOFR, and future payments of royalty fees depend on our future revenue from DEXTENZA, both of which cannot be estimated at this time.
Future payments of interest under the Barings Credit Agreement depend on the level of the Secured Overnight Financing Rate, or SOFR, and future payments of royalty fees depend on our future revenue from DEXTENZA, both of which cannot be estimated at this time.
Based on our current operating plan, which includes estimates of anticipated cash inflows from DEXTENZA product sales and cash outflows from operating expenses and capital expenditures and reflects our observance of the minimum liquidity covenant of $20.0 million under the Barings Credit Agreement, we believe that our existing cash and cash equivalents as of December 31, 2024 will enable us to fund our planned operating expenses, debt service obligations and capital expenditure requirements into 2028.
Based on our current operating plan, which includes estimates of anticipated cash inflows from DEXTENZA product sales and cash outflows from operating expenses and capital expenditures and reflects our observance of the minimum liquidity covenant of $20.0 million under the Barings Credit Agreement, we believe that our existing cash and cash equivalents as of December 31, 2025 will enable us to fund our planned operating expenses, debt service obligations and capital expenditure requirements into 2028.
The covenants under the Barings Credit Facility and our pledge of our assets as collateral to secure our obligations under the Barings Credit Facility pursuant to which we have a total borrowing capacity of $82.5 million, which has been fully drawn down, may limit our ability to obtain additional debt or other financing.
Our pledge of our assets as collateral to secure our obligations under the Barings Credit Facility pursuant to which we have a total borrowing capacity of $82.5 million, which has been fully drawn down, may limit our ability to obtain additional debt or other financing.
Net cash used by net unfavorable changes in our operating assets and liabilities during the year ended December 31, 2023 consisted primarily of increases of accounts receivables of $4.9 million, increases of prepaid expenses and other current assets of $3.8 million, partially offset by increases of other items, net, of $1.2 million.
Net cash used by net unfavorable changes in our operating assets and liabilities during the year ended December 31, 2023 consisted primarily of increases of accounts receivables of $4.9 million, increases of prepaid expenses and other current assets of $3.8 million, partially offset by increases of other items, net, of $1.2 million. Investing activities.
Comparison of the Years Ended December 31, 2023 and 2022 A discussion of changes in our results of operations during the year ended December 31, 2023 compared to the year ended December 31, 2022 has been omitted from this Annual Report on Form 10-K but may be found in “Item 7.
Comparison of the Years Ended December 31, 2024 and 2023 A discussion of changes in our results of operations during the year ended December 31, 2024 compared to the year ended December 31, 2023 has been omitted from this Annual Report on Form 10-K but may be found in “Item 7.
The settlement of the Conversion Option Derivative Liability occurred on March 28, 2024. The changes in fair value of these derivative liabilities are recorded through the consolidated statement of operations and comprehensive loss and are presented under the caption “change in fair value of derivative liabilities”. Gains and Losses from Debt Extinguishment .
The settlement of the Conversion Option Derivative Liability occurred on March 28, 2024. The changes in fair value of these derivative liabilities are recorded through the consolidated statements of operations and comprehensive loss and are presented under the caption “change in fair value of derivative liabilities”. Gains and Losses from Debt Extinguishment .
Net cash used in investing activities was $1.3 million for the year ended December 31, 2024, consisting of cash used to purchase property and equipment and leasehold improvements. Net cash used in investing activities was $6.1 million for the year ended December 31, 2023, consisting of cash used to purchase property and equipment and leasehold improvement.
Net cash used in investing activities was $1.3 million for the year ended December 31, 2024, consisting of cash used to purchase property and equipment and leasehold improvements. Net cash used in investing activities was $6.1 million for the year ended December 31, 2023, consisting of cash used to purchase property and equipment and leasehold improvements. Financing activities.
The calculation of the accrual for co-pay assistance is based on an estimate of claims and the cost per claim that we expect to receive associated with product that has been recognized as revenue, but remains in the distribution channel inventories at the end of each reporting period.
The calculation of the accrual for co-pay assistance is based on an estimate of claims and the cost per claim that we expect to receive associated with product that has been recognized 130 Table of Contents as revenue, but remains in the distribution channel inventories at the end of each reporting period.
We do not have any committed external source of funds, although our license agreement with AffaMed provides for AffaMed’s reimbursement of certain clinical expenses incurred by us in connection with our collaboration and for our potential receipt of development and sales milestone payments and royalty payments.
We do not have any committed 125 Table of Contents external source of funds, although our license agreement with AffaMed provides for AffaMed’s reimbursement of certain clinical expenses incurred by us in connection with our collaboration and for our potential receipt of development and sales milestone payments and royalty payments.
Management’s Discussion and Analysis of Financial Condition and Results of Operations” in our Annual Report on Form 10-K for the year ended December 31, 2023, filed with the SEC on March 11, 2024, which discussion is incorporated herein by reference and which is available free of charge on the SECs website at www.sec.gov.
Management’s Discussion and Analysis of Financial Condition and Results of Operations” in our Annual Report on Form 10-K for the year ended December 31, 2024, filed with the SEC on March 3, 2025, which discussion is incorporated herein by reference and which is available free of charge on the SECs website at www.sec.gov.
Change in Fair Value of Derivative Liabilities. We recognized a net loss from the change in fair values of our derivative liabilities of $0.5 million for the year ended December 31, 2024, compared to a net loss of $5.2 million for the year ended December 31, 2023.
We recognized a net loss from the change in fair values of our derivative liabilities of $2.5 million for the year ended December 31, 2025, compared to a net loss of $0.5 million for the year ended December 31, 2024.
Debt financing and preferred equity financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends.
Debt financing, such as our existing Barings Credit Facility, and preferred equity financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends.
As of December 31, 2024, we had cash and cash equivalents of $392.1 million, and outstanding notes payable with a principal amount of $82.5 million par value under the Barings Credit Facility.
As of December 31, 2025, we had cash and cash equivalents of $737.1 million, and outstanding notes payable with a principal amount of $82.5 million par value under the Barings Credit Facility.
We anticipate we will incur substantial expenses if and as we: ● continue our ongoing clinical trials, including the SOL-1 and the SOL-R trials, our two registrational Phase 3 clinical trials of AXPAXLI for the treatment of wet AMD; ● initiate any additional clinical trials we might determine in the future to conduct for our product candidates, including any clinical trials that we might conduct for AXPAXLI for the treatment of NPDR and DME; ● scale up our manufacturing processes and capabilities to support sales of commercial products, clinical trials of our product candidates, including AXPAXLI, and commercialization of any of our product candidates for which we obtain marketing approval, and expand our facilities to accommodate this scale up and any corresponding growth in personnel; ● scale up our sales, marketing and distribution capabilities to prepare for commercialization of any product candidates for which we intend to obtain marketing approval; ● seek marketing approvals for any of our product candidates that successfully complete clinical development; ● continue to monitor subjects according to the applicable clinical trial protocols, or prepare submission documentation such as clinical study reports, for our clinical trials that have been completed; ● continue to commercialize DEXTENZA in the United States; ● maintain, expand and protect our intellectual property portfolio; 116 Table of Contents ● expand our operational, quality assurance, financial, administrative and management systems and personnel, including personnel to support our clinical development, manufacturing and commercialization efforts; ● defend ourselves against legal proceedings, if any; ● make investments to improve our defenses against cybersecurity threats and establish and maintain cybersecurity insurance; ● increase our product liability and clinical trial insurance coverage as we expand our clinical trials and commercialization efforts; and ● continue to operate as a public company.
We anticipate we will incur substantial expenses if and as we: ● continue our ongoing registrational programs, including the SOL registrational program of AXPAXLI for the treatment of wet AMD, and the HELIOS registrational program of AXPAXLI for the treatment of diabetic retinal disease, including NPDR; ● initiate our planned SOL-X trial, our long-term extension study of AXPAXLI for the treatment of wet AMD; ● initiate any additional clinical trials we might determine in the future to conduct for our product candidates; ● scale up our manufacturing processes and capabilities to support sales of commercial products, clinical trials of our product candidates, including AXPAXLI, and commercialization of any of our product candidates for which we obtain marketing approval, and expand our facilities to accommodate this scale up and any corresponding growth in personnel; ● scale up our sales, marketing and distribution capabilities to prepare for commercialization of any product candidates for which we intend to obtain marketing approval; ● continue to monitor subjects according to the applicable clinical trial protocols, or prepare submission documentation such as clinical study reports, for our clinical trials that have been completed; ● seek marketing approvals for any of our product candidates that successfully complete clinical development; ● continue to commercialize DEXTENZA in the United States; ● maintain, expand and protect our intellectual property portfolio; ● expand our operational, quality assurance, financial, administrative and management systems and personnel, including personnel to support our clinical development, manufacturing and commercialization efforts; ● defend ourselves against legal proceedings, if any; ● make investments to improve our defenses against cybersecurity threats and establish and maintain cybersecurity insurance; ● increase our product liability and clinical trial insurance coverage as we expand our clinical trials and commercialization efforts; and ● continue to operate as a public company.
Net cash provided by financing activities for the year ended December 31, 2023 was $169.8 million and consisted of proceeds from the issuance of common stock in public offerings of $117.3 million, drawings under the Barings Credit Facility of $77.3 million, net of issuance costs, proceeds from the issuance of common stock pursuant to our employee stock purchase plan of $0.9 million and proceeds from the exercise of stock options of $0.6 million, partially offset by repayment of the MidCap Credit Facility of $26.1 million.
Net cash provided by financing activities for the year ended December 31, 2023 was $169.8 million and consisted of proceeds from the issuance of common stock in public offerings of $117.3 million, gross proceeds received from drawings under the Barings Credit Facility of $82.5 million, proceeds from the issuance of common stock pursuant to our employee stock purchase plan of $0.9 million and proceeds from the exercise of stock options of $0.6 million, partially offset by repayment of the MidCap Credit Facility of $26.1 million and payments of debt refinancing costs of $5.2 million.
The net loss for 2024 comprises of a gain of $2.6 million from the change in the fair value of the Conversion Option Derivative Liability, a loss of $0.9 million from the change in the fair value of the Royalty Fee Derivative Liability, and an expense of $2.2 million related to royalty fees under the Barings Credit Agreement that we paid or accrued.
The net loss for the year ended December 31, 2024 comprises of a gain of $2.6 million from the change in the fair value of the Conversion Option Derivative 122 Table of Contents Liability, a loss of $0.9 million from the change in the fair value of the Royalty Fee Derivative Liability, and an expense of $2.2 million related to royalty fees under the Barings Credit Agreement that we paid or accrued.
For the year ended December 31, 2024, our interest-bearing debt included the Barings Credit Facility ($82.5 million outstanding principal) and the Convertible Notes (through March 28, 2024, no outstanding principal thereafter).
For the year ended December 31, 2024, our interest-bearing debt included the Barings Credit Facility ($82.5 million outstanding principal) and our $37.5 million unsecured senior subordinated convertible notes, or the Convertible Notes ($37.5 million outstanding principal through March 28, 2024, no outstanding principal thereafter).
Our future capital requirements will depend on many factors, including: ● the progress, costs and outcome of our ongoing clinical trials of AXPAXLI for the treatment of wet AMD; ● the timing, scope, progress, costs and outcome of a potential registrational clinical program of AXPAXLI for the treatment of NPDR and DME; ● the costs, timing and outcome of regulatory review of AXPAXLI or our other product candidates by the FDA, the European Medicines Agency, or EMA, or other regulatory authorities; ● the scope, progress, costs and outcome of preclinical development and any additional clinical trials we might determine in the future to conduct for our other product candidates, including PAXTRAVA for the reduction of intraocular pressure, or IOP, in patients with primary open-angle glaucoma, or OAG, or ocular hypertension, or OHT; ● the level of product sales from DEXTENZA and any additional products for which we obtain marketing approval in the future and the level of third-party reimbursement of such products; ● the costs of sales, marketing, distribution and other commercialization efforts with respect to DEXTENZA and any of our product candidates for which we obtain marketing approval in the future, including cost increases due to inflation; ● the costs of scaling up our manufacturing processes and capabilities to support sales of commercial products, clinical trials of our product candidates, including AXPAXLI, and commercialization of any of our product candidates for which we obtain marketing approval, including AXPAXLI, and of expanding our facilities to accommodate this scale up and any corresponding growth in personnel; ● the extent of our debt service obligations and our ability, if desired, to refinance any of our existing debt on terms that are more favorable to us; ● the amounts we are entitled to receive, if any, as reimbursements for clinical trial expenditures, development, regulatory, and sales milestone payments, and royalty payments under our license agreement with AffaMed; 117 Table of Contents ● the extent to which we choose to establish additional collaboration, distribution or other marketing arrangements for our products and product candidates; ● the costs and outcomes of any legal actions and proceedings; ● the costs and timing of preparing, filing and prosecuting patent applications, maintaining and enforcing our intellectual property rights and defending any intellectual property-related claims; and ● the extent to which we acquire or invest in other businesses, products and technologies.
Our future capital requirements will depend on many factors, including: ● the progress, costs and outcomes of our ongoing SOL and HELIOS registrational programs of AXPAXLI for the treatment of wet AMD and for the treatment of diabetic retinal disease, including NPDR, respectively; ● the timing, scope, progress, costs and outcome of our planned SOL-X trial, our long-term extension study of AXPAXLI for the treatment of wet AMD; ● the costs, timing and outcome of regulatory review of AXPAXLI or our other product candidates by the FDA, the European Medicines Agency, or EMA, or other regulatory authorities; ● the scope, progress, costs and outcome of preclinical development and any additional clinical trials we might determine in the future to conduct for our other product candidates, including OTX-TIC for the reduction of intraocular pressure, or IOP, in patients with primary open-angle glaucoma, or OAG, or ocular hypertension, or OHT; ● the costs of developing, validating and scaling up our manufacturing processes and capabilities to support sales of commercial products, clinical trials of our product candidates, including AXPAXLI, and commercialization of any of our product candidates for which we may obtain marketing approval, including AXPAXLI, and of expanding our facilities to accommodate this scale up and any corresponding growth in personnel; ● the costs of sales, marketing, distribution and other commercialization efforts with respect to DEXTENZA and any of our product candidates for which we obtain or may obtain marketing approval in the future, such as AXPAXLI, including costs related to preparing for and implementing the potential marketing of AXPAXLI outside the United States; ● the level of product sales from DEXTENZA and any additional products for which we obtain marketing approval in the future and the level of third-party reimbursement of such products; ● cost increases due to inflation; ● the extent of our debt service obligations and our ability, if desired, to refinance any of our existing debt on terms that are more favorable to us; ● the amounts we are entitled to receive, if any, as reimbursements for clinical trial expenditures, development, regulatory, and sales milestone payments, and royalty payments under our license agreement with AffaMed; ● the extent to which we choose to establish additional collaboration, distribution or other marketing arrangements for our products and product candidates; ● the costs and outcomes of any legal actions and proceedings; ● the costs and timing of preparing, filing and prosecuting patent applications, maintaining and enforcing our intellectual property rights and defending any intellectual property-related claims; and ● the extent to which we acquire or invest in other businesses, products and technologies.
Each pre-funded warrant has an exercise price of $0.001 per share, is currently exercisable and will remain exercisable until exercised in full. 115 Table of Contents On December 18, 2023, we sold 35,420,000 shares of our common stock in an underwritten public offering at a public offering price of $3.25 per share.
Each pre-funded warrant that remains outstanding has an exercise price of $0.001 per share, is currently exercisable and will remain exercisable until exercised in full. In December 2023, we sold 35,420,000 shares of our common stock in an underwritten public offering at a public offering price of $3.25 per share.
Revenue Recognition We recognize product revenue from the sales of DEXTENZA product. In November 2018, the FDA approved DEXTENZA for the treatment of ocular pain following ophthalmic surgery. We entered into a limited number of arrangements with specialty distributors in the United States to distribute DEXTENZA.
In November 2018, the FDA approved DEXTENZA for the treatment of ocular pain following ophthalmic surgery. We entered into a limited number of arrangements with specialty distributors in the United States to distribute DEXTENZA.
In August 2021, we entered into an Open Market Sale Agreement, or the 2021 Sales Agreement, with Jefferies LLC, or Jefferies, under which we may offer and sell shares of our common stock having an aggregate offering price of up to $100.0 million from time to time through Jefferies, acting as agent.
In August 2021, we entered into an Open Market Sale Agreement, or the 2021 Sales Agreement, with Jefferies LLC, or Jefferies, under which we may offer and sell shares of our common stock from time to time through Jefferies, acting as agent.
Overview Our Company We are a biopharmaceutical company committed to redefining the retina experience. AXPAXLI (axitinib intravitreal hydrogel, also known as OTX-TKI), our product candidate for retinal disease, is based on our proprietary ELUTYX bioresorbable hydrogel-based formulation technology.
Overview Our Company We are an integrated biopharmaceutical company committed to redefining the retina experience. AXPAXLI, also known as OTX-TKI), our investigational product candidate for retinal disease, is an axitinib intravitreal hydrogel based 114 Table of Contents on our ELUTYX proprietary bioresorbable hydrogel-based formulation technology.
Pursuant to 42 U.S.C. par. 1395 et seq., or the Medicare Statute, physician administered non-opioid pain medications will receive separate payment in both the ASC and HOPD settings of care effective as of January 1, 2025.
Pursuant to 42 U.S.C. par. 1395 et seq., or the Medicare Statute, physician administered non-opioid pain medications have received separate payment in both the ASC and HOPD settings of care effective as of January 1, 2025. The Medicare Statute allows for continued separate payment of DEXTENZA in the ASC and HOPD settings in 2026.
Net cash used by net unfavorable changes in our operating assets and liabilities during the year ended December 31, 2024 consisted primarily of increases of accounts receivable of $6.2 million, resulting from increased sales of DEXTENZA, and increases of prepaid expenses and other current assets of $5.7 million, resulting predominantly from our clinical development activities, partially offset by other decreases, net, of $1.6 million. 118 Table of Contents Net cash used in operating activities was $70.2 million for the year ended December 31, 2023, primarily resulting from our net loss of $80.7 million and net unfavorable changes in operating assets and liabilities of $7.4 million, partially offset by non-cash adjustments of $17.9 million.
Net cash used by net unfavorable changes in our operating assets and liabilities during the year ended December 31, 2024 consisted primarily of increases of accounts receivable of $6.2 million, resulting from increased 126 Table of Contents sales of DEXTENZA, and increases of prepaid expenses and other current assets of $5.7 million, resulting predominantly from our clinical development activities, partially offset by other decreases, net, of $1.6 million.
While our significant accounting policies are described in more detail in the notes to our consolidated financial statements appearing elsewhere in this Annual Report on Form 10-K, we believe the following accounting policies to be most critical to the judgments and estimates used in the preparation of our consolidated financial statements.
While our significant accounting policies are described in more detail in the notes to our consolidated financial statements appearing elsewhere in this Annual Report on Form 10-K, we believe the following accounting policies to be most critical to the judgments and estimates used in the preparation of our consolidated financial statements. 128 Table of Contents Revenue Recognition We recognize product revenue from the sales of DEXTENZA product.
Our net loss was primarily attributed to operating expenses of $130.1 million, which we incurred primarily for research and development activities, selling and marketing activities, and general and administrative activities, partially offset by $51.5 million of revenue and a net non-operating income of $7.6 million.
Our net loss was primarily attributed to operating expenses of $322.0 million, which we incurred primarily for research and development activities, selling and marketing activities, and general and administrative activities, and non-operating expenses, net, of $4.1 million, partially offset by $51.9 million of revenue.
Product revenues are recorded net of applicable reserves for variable consideration, including discounts and allowances. 121 Table of Contents Transaction Price, including Variable Consideration — Revenues from product sales are recorded at the net sales price (transaction price), which includes estimates of variable consideration for which reserves are established.
Transaction Price, including Variable Consideration — Revenues from product sales are recorded at the net sales price (transaction price), which includes estimates of variable consideration for which reserves are established.
Off-Balance Sheet Arrangements We did not have during the periods presented, and we do not currently have, any off-balance sheet arrangements, as defined in the rules and regulations of the Securities and Exchange Commission, such relationships with unconsolidated entities or financial partnerships, which are often referred to as structured finance or special purpose entities, established for the purpose of facilitating financing transactions that are not required to be reflected on our balance sheets. 120 Table of Contents Critical Accounting Policies and Significant Judgments and Estimates Our consolidated financial statements are prepared in accordance with generally accepted accounting principles in the United States of America.
Off-Balance Sheet Arrangements We did not have during the periods presented, and we do not currently have, any off-balance sheet arrangements, as defined in the rules and regulations of the Securities and Exchange Commission, such relationships with unconsolidated entities or financial partnerships, which are often referred to as structured finance or special purpose entities, established for the purpose of facilitating financing transactions that are not required to be reflected on our balance sheets.
Contractual Obligations and Commitments ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Less Than ​ 1 to 3 ​ 3 to 5 ​ More than ​ Total 1 Year Years Years 5 Years ​ ​ (in thousands) Operating lease commitments ​ $ 8,737 ​ $ 2,722 ​ ​ 5,265 ​ ​ 750 ​ ​ — Barings Credit Agreement ​ 82,474 ​ — ​ ​ — ​ ​ 82,474 ​ ​ — Total ​ $ 91,211 ​ $ 2,722 ​ $ 5,265 ​ $ 83,224 ​ $ — ​ The table above includes our enforceable and legally binding obligations and future commitments at December 31, 2024, as well as obligations related to contracts that we are likely to continue, regardless of the fact that they may be cancelable at December 31, 2024.
Contractual Obligations and Commitments ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Less Than ​ 1 to 3 ​ 3 to 5 ​ More than ​ ​ ​ ​ Total ​ ​ ​ 1 Year ​ ​ ​ Years ​ ​ ​ Years ​ ​ ​ 5 Years ​ ​ (in thousands) Operating lease commitments ​ $ 6,250 ​ $ 3,235 ​ ​ 3,015 ​ ​ — ​ ​ — Barings Credit Agreement ​ 82,474 ​ — ​ ​ — ​ ​ 82,474 ​ ​ — Total ​ $ 88,724 ​ $ 3,235 ​ $ 3,015 ​ $ 82,474 ​ $ — ​ The table above includes our enforceable and legally binding obligations and future commitments at December 31, 2025, as well as obligations related to contracts that we are likely to continue, regardless of the fact that they may be cancelable at December 31, 2025.
Cash Flows The following table summarizes our sources and uses of cash for each of the periods presented: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Year Ended December 31, ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ 2024 2023 2022 Cash used in operating activities ​ $ (134,677) ​ $ (70,234) ​ $ (59,603) Cash used in investing activities ​ (1,288) ​ (6,087) ​ (3,715) Cash provided by financing activities ​ 332,110 ​ 169,828 ​ 1,454 Net increase in cash and cash equivalents ​ $ 196,145 ​ $ 93,507 ​ $ (61,864) ​ Operating activities.
Cash Flows The following table summarizes our sources and uses of cash for each of the periods presented: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Year Ended December 31, ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ 2025 ​ ​ ​ 2024 ​ ​ ​ 2023 Cash used in operating activities ​ $ (204,883) ​ $ (134,677) ​ $ (70,234) Cash used in investing activities ​ (11,880) ​ (1,288) ​ (6,087) Cash provided by financing activities ​ 561,721 ​ 332,110 ​ 169,828 Net increase in cash and cash equivalents ​ $ 344,958 ​ $ 196,145 ​ $ 93,507 ​ Operating activities.
The trade payment terms with our customers do not exceed one year and therefore we have elected to apply the practical expedient and no amount of consideration has been allocated as a financing component.
The trade payment terms with our customers do not exceed one year and therefore we have elected to apply the practical expedient and no amount of consideration has been allocated as a financing component. Product revenues are recorded net of applicable reserves for variable consideration, including discounts and allowances.
Within research and development expenses, direct expenses for clinical programs increased $46.3 million, unallocated expenses increased $20.9 million, and expenses for preclinical programs decreased $0.6 million. For the year ended December 31, 2024, we incurred $65.6 million in direct research and development expenses for our products and product candidates compared to $19.9 million for the year ended December 31, 2023.
Within research and development expenses, direct expenses for clinical programs increased $63.2 million, unallocated expenses increased $7.1 million, and expenses for preclinical programs decreased $0.8 million. For the year ended December 31, 2025, we incurred $128.0 million in direct research and development expenses for our products and product candidates compared to $65.6 million for the year ended December 31, 2024.
General and Administrative Expenses ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Year Ended ​ ​ ​ ​ ​ ​ ​ ​ December 31, ​ Increase (Decrease) ​ 2024 2023 ​ 2022 2024 - 2023 2023 - 2022 ​ ​ (in thousands) ​ ​ Personnel-related (including stock-based compensation) ​ $ 40,273 ​ $ 21,356 ​ $ 18,227 ​ $ 18,917 ​ $ 3,129 Professional fees ​ 15,568 ​ 10,821 ​ 11,634 ​ 4,747 ​ (813) Facility-related and other ​ 4,812 ​ 1,763 ​ 2,363 ​ 3,049 ​ (600) Total general and administrative expenses ​ $ 60,653 ​ $ 33,940 ​ $ 32,224 ​ $ 26,713 ​ $ 1,716 ​ General and administrative expenses were $60.7 million and $33.9 million for the years ended December 31, 2024 and 2023, respectively, reflecting an increase of $26.7 million year-over-year.
General and Administrative Expenses ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Year Ended ​ ​ ​ ​ ​ ​ ​ ​ December 31, ​ Increase (Decrease) ​ ​ ​ ​ 2025 ​ ​ ​ 2024 ​ ​ ​ 2023 ​ ​ ​ 2025 - 2024 ​ ​ ​ 2024 - 2023 ​ ​ (in thousands) Personnel-related (including stock-based compensation) ​ $ 43,294 ​ $ 40,273 ​ $ 21,356 ​ $ 3,021 ​ $ 18,917 Professional fees ​ 14,147 ​ 15,568 ​ 10,821 ​ (1,421) ​ 4,747 Facility-related and other ​ 6,935 ​ 4,812 ​ 1,763 ​ 2,123 ​ 3,049 Total general and administrative expenses ​ $ 64,376 ​ $ 60,653 ​ $ 33,940 ​ $ 3,723 ​ $ 26,713 ​ General and administrative expenses were $64.4 million and $60.7 million for the years ended December 31, 2025 and 2024, respectively, reflecting an increase of $3.7 million year-over-year.
Net cash used in operating activities was $59.6 million for the year ended December 31, 2022, primarily resulting from our net loss of $71.0 million, partially offset by non-cash adjustments of $10.1 million and net favorable changes in operating assets and liabilities of $1.3 million.
Net cash used in operating activities was $204.9 million for the year ended December 31, 2025, primarily resulting from our net loss of $265.9 million, partially offset by non-cash adjustments of $53.3 million and net favorable changes in operating assets and liabilities of $7.7 million.
Selling and Marketing Expenses ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Year Ended ​ ​ ​ ​ ​ ​ ​ ​ December 31, ​ Increase (Decrease) ​ 2024 2023 ​ 2022 2024 - 2023 2023 - 2022 ​ ​ (in thousands) Personnel-related (including stock-based compensation) ​ $ 27,576 ​ $ 27,434 ​ $ 26,679 ​ $ 142 ​ $ 755 Professional fees ​ 8,899 ​ 8,287 ​ 9,077 ​ 612 ​ ​ (790) Facility-related and other ​ 5,115 ​ 4,828 ​ 4,166 ​ 287 ​ ​ 662 Total selling and marketing expenses ​ $ 41,590 ​ $ 40,549 ​ $ 39,922 ​ $ 1,041 ​ $ 627 ​ Selling and marketing expenses were $41.6 million and $40.5 million for the years ended December 31, 2024 and 2023, respectively, reflecting an increase of $1.0 million year-over-year.
Selling and Marketing Expenses ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Year Ended ​ ​ ​ ​ ​ ​ ​ ​ December 31, ​ Increase (Decrease) ​ ​ ​ ​ 2025 ​ ​ ​ 2024 ​ ​ ​ 2023 ​ ​ ​ 2025 - 2024 ​ ​ ​ 2024 - 2023 ​ ​ (in thousands) Personnel-related (including stock-based compensation) ​ $ 33,448 ​ $ 27,576 ​ $ 27,434 ​ $ 5,872 ​ $ 142 Professional fees ​ 14,326 ​ 8,899 ​ 8,287 ​ 5,427 ​ 612 Facility-related and other ​ 6,148 ​ 5,115 ​ 4,828 ​ 1,033 ​ 287 Total selling and marketing expenses ​ $ 53,922 ​ $ 41,590 ​ $ 40,549 ​ $ 12,332 ​ $ 1,041 ​ Selling and marketing expenses were $53.9 million and $41.6 million for the years ended December 31, 2025 and 2024, respectively, reflecting an increase of $12.3 million year-over-year.
The increase was primarily due to an increase of $18.9 million in personnel-related costs including stock-based compensation, an increase in professional fees of $4.7 million and an increase of $3.0 million in facility related and other costs.
The increase was primarily due to an increase of $3.0 million in personnel-related costs including stock-based compensation, and an increase of $2.1 million in facility-related and other costs, including IT, partially offset by a decrease in professional fees of $1.4 million.
Non-cash adjustments primarily include stock-based compensation expense of $17.0 million, non-cash income related to changes in the fair value of our derivative liabilities of $13.8 million, non-cash interest expense of $4.9 million, and depreciation and amortization expense of $2.1 million.
Non-cash adjustments primarily include stock-based compensation expense of $43.2 million, depreciation and amortization expense of $4.3 million, non-cash interest expense of $3.4 million, and a net non-cash loss related to changes in the fair value of our derivative liabilities of $2.5 million.
Our liability for these rebates consists of invoices received for claims from prior quarters that have not been paid or for which an invoice has not yet been received, estimates of claims for the current quarter, and estimated future claims that will be made for product that has been recognized as revenue, but which remains in the distribution channel inventories at the end of each reporting period. 122 Table of Contents Purchaser/Provider Discounts and Rebates —We offer rebate payments for which ASCs, HOPDs and other prescribers qualify by meeting quarterly purchase volumes of DEXTENZA under our volume-based rebate program.
Our liability for these rebates consists of invoices received for claims from prior quarters that have not been paid or for which an invoice has not yet been received, estimates of claims for the current quarter, and estimated future claims that will be made for product that has been recognized as revenue, but which remains in the distribution channel inventories at the end of each reporting period.
Gains and Losses on Extinguishment of Debt, Net. We recognized a non-cash loss on extinguishment of debt of $28.0 million for the year ended December 31, 2024, compared to a gain, net, on extinguishment of debt of $14.2 million for the year ended December 31, 2023.
Gains and Losses on Extinguishment of Debt, Net. We recognized a non-cash loss on extinguishment of debt of $28.0 million for the year ended December 31, 2024, resulting from the conversion of the Convertible Notes in March 2024.
Personnel-related costs, including stock-based compensation, for the year ended December 31, 2024 include $1.6 million related to wages, severance, and other benefits under the Strategic Restructuring, and $9.3 million related to accrued severance and acceleration of stock-based compensation for certain former members of our senior leadership team who departed during the year ended December 31, 2024 separate from the Strategic Restructuring.
In the year ended December 31, 2024, we executed and completed a strategic reduction in force as part of an initiative to prioritize our resources on the clinical development of AXPAXLI for wet AMD, or the Strategic Restructuring Personnel-related costs, including stock-based compensation, for the year ended December 31, 2024 include $1.6 million related to wages, severance, and other benefits under the Strategic Restructuring, and $9.3 million related to accrued severance and acceleration of stock-based compensation for certain former members of our senior leadership team who departed during the year ended December 31, 2024 separate from the Strategic Restructuring, including our former Chief Executive Officer, our former Chief Business Officer, and our former Chief Medical Officer.
Other Income (Expense), Net Interest Income . Interest income was $20.3 million and $4.0 million for the years ended December 31, 2024 and 2023, respectively, reflecting an increase of $16.3 million year-over-year. The increase is primarily due to a higher average balance of cash and cash equivalents held by us, and higher interest rates. Interest Expense .
Other Income (Expense), Net Interest Income . Interest income was $18.4 million and $20.3 million for the years ended December 31, 2025 and 2024, respectively, reflecting a decrease of $1.9 million year-over-year. The decrease is attributable primarily to a lower average balance of interest-generating cash and cash equivalents. Interest Expense .
All of our product revenue, net, was attributable to sales of DEXTENZA. Our total gross-to-net provisions, or GTN Provisions, for the years ended December 31, 2024 and 2023 were 38.5% and 30.1%, respectively, of gross DEXTENZA product sales. We increased the wholesale acquisition cost, or WAC, for DEXTENZA effective April 2024 and again effective October 2024.
All of our product revenue, net, was attributable to sales of DEXTENZA. Our total GTN Provisions for the years ended December 31, 2025 and 2024 were 51.6% and 38.5%, respectively, of gross DEXTENZA product sales.
Some of the figures that we include in this table are based on management’s estimates and assumptions about these obligations, including their duration, and other factors. Because 119 Table of Contents these estimates and assumptions are necessarily subjective, the amounts we will actually pay in future periods may vary from those reflected in the table.
Some of the figures that we include in this table are based on management’s estimates and assumptions about these obligations, including their duration, and other factors.
We also leverage the ELUTYX technology in our commercial product DEXTENZA, an FDA-approved corticosteroid for the treatment of ocular inflammation and pain following ophthalmic surgery and for the treatment of ocular itching associated with allergic conjunctivitis, and our product candidate PAXTRAVA (travoprost intracameral hydrogel also known as OTX-TIC), which is currently in a Phase 2 clinical trial for the treatment of open-angle glaucoma, or OAG, or ocular hypertension, or OHT.
Food and Drug Administration, or FDA, for the treatment of ocular inflammation and pain following ophthalmic surgery in adults and pediatric patients and for the treatment of ocular itching associated with allergic conjunctivitis in adults and pediatric patients aged two years or older, and in our product candidate OTX-TIC, which is a travoprost intracameral hydrogel that has completed a Phase 2 clinical trial for the treatment of open-angle glaucoma, or OAG, or ocular hypertension, or OHT.
We recognize collaboration revenue based on a cost-to-cost method. 112 Table of Contents Research and Development Expenses ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Year Ended ​ ​ ​ ​ ​ ​ ​ ​ December 31, ​ Increase (Decrease) ​ 2024 2023 ​ 2022 2024 - 2023 2023 - 2022 ​ (in thousands) Direct research and development expenses by program: ​ ​ ​ ​ ​ ​ ​ ​ ​ AXPAXLI for wet AMD ​ $ 57,507 ​ $ 8,750 ​ $ 5,296 ​ $ 48,757 ​ $ 3,454 AXPAXLI for NPDR ​ 2,301 ​ 2,868 ​ ​ 659 ​ (567) ​ 2,209 PAXTRAVA for OAG or OHT ​ ​ 2,331 ​ ​ 3,600 ​ ​ 2,835 ​ ​ (1,269) ​ ​ 765 DEXTENZA for post-surgical ocular inflammation and pain ​ ​ 2,115 ​ ​ 2,224 ​ ​ 1,649 ​ ​ (109) ​ ​ 575 OTX-DED for the short-term treatment of the signs and symptoms of dry eye disease ​ 499 ​ 837 ​ ​ 328 ​ (338) ​ 509 OTX-CSI for treatment of dry eye disease ​ — ​ 161 ​ ​ 453 ​ (161) ​ (292) DEXTENZA for ocular itching associated with allergic conjunctivitis ​ ​ — ​ ​ — ​ ​ 21 ​ ​ — ​ ​ (21) Preclinical programs ​ ​ 853 ​ ​ 1,501 ​ ​ 1,947 ​ ​ (648) ​ ​ (446) Unallocated expenses: ​ ​ ​ ​ ​ ​ ​ ​ ​ — Personnel costs ​ 37,818 ​ 27,068 ​ ​ 25,106 ​ 10,750 ​ 1,962 All other costs ​ 24,211 ​ 14,046 ​ ​ 15,168 ​ 10,165 ​ (1,122) Total research and development expenses ​ $ 127,635 ​ $ 61,055 ​ $ 53,462 ​ $ 66,580 ​ $ 7,593 ​ Research and development expenses were $127.6 million and $61.1 million for the years ended December 31, 2024 and 2023, respectively, reflecting an increase of $66.6 million year-over-year.
We do not expect to recognize additional collaboration revenue for 2026, as we do not expect that the additional performance obligations under our license agreement with AffaMed will be fully or partially satisfied in 2026. 120 Table of Contents Research and Development Expenses ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Year Ended ​ ​ ​ ​ ​ ​ ​ ​ December 31, ​ Increase (Decrease) ​ ​ ​ ​ 2025 ​ ​ ​ 2024 ​ ​ ​ 2023 ​ ​ ​ 2025 - 2024 ​ ​ ​ 2024 - 2023 ​ (in thousands) Direct research and development expenses by program: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ AXPAXLI for wet AMD ​ $ 119,608 ​ $ 57,507 ​ $ 8,750 ​ $ 62,101 ​ $ 48,757 AXPAXLI for NPDR ​ 4,804 ​ 2,301 ​ ​ 2,868 ​ 2,503 ​ (567) OTX-TIC for OAG or OHT ​ ​ 535 ​ ​ 2,331 ​ ​ 3,600 ​ ​ (1,796) ​ ​ (1,269) DEXTENZA for post-surgical ocular inflammation and pain ​ ​ 3,023 ​ ​ 2,115 ​ ​ 2,224 ​ ​ 908 ​ ​ (109) OTX-DED for the short-term treatment of the signs and symptoms of dry eye disease ​ 12 ​ 499 ​ ​ 837 ​ (487) ​ (338) OTX-CSI for treatment of dry eye disease ​ 3 ​ — ​ ​ 161 ​ 3 ​ (161) DEXTENZA for ocular itching associated with allergic conjunctivitis ​ ​ — ​ ​ — ​ ​ — ​ ​ — ​ ​ — Preclinical programs ​ ​ 9 ​ ​ 853 ​ ​ 1,501 ​ ​ (844) ​ ​ (648) Unallocated expenses: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Personnel costs ​ 52,644 ​ 37,818 ​ ​ 27,068 ​ 14,826 ​ 10,750 All other costs ​ 16,458 ​ 24,211 ​ ​ 14,046 ​ (7,753) ​ 10,165 Total research and development expenses ​ $ 197,096 ​ $ 127,635 ​ $ 61,055 ​ $ 69,461 ​ $ 66,580 ​ Research and development expenses were $197.1 million and $127.6 million for the years ended December 31, 2025 and 2024, respectively, reflecting an increase of $69.5 million year-over-year.
AXPAXLI is currently in two repeat-dosing Phase 3 clinical trials for the treatment of wet age-related macular degeneration, or wet AMD, which we refer to as the SOL-1 and the SOL-R trials. We have also completed a Phase 1 clinical trial of AXPAXLI for the treatment of non-proliferative diabetic retinopathy, or NPDR, which we refer to as the HELIOS trial.
AXPAXLI is currently being evaluated in a Phase 3 registrational program for wet age-related macular degeneration, or wet AMD, which we refer to as the SOL program. AXPAXLI is currently also being evaluated in a Phase 3 registrational program for diabetic retinal disease, including non-proliferative diabetic retinopathy, or NPDR, which we refer to as the HELIOS program.
Actual amounts of consideration ultimately received may differ from our estimates. If actual results in the future vary from our original estimates, we will adjust these estimates, which would affect net product revenue and earnings in the period such variances become known.
If actual results in the future vary from our original estimates, we will adjust these estimates, which would affect net product revenue and earnings in the period such variances become known. 129 Table of Contents Trade Discounts and Allowances —We compensate (through trade discounts and allowances) our customers for sales order management, data, and distribution services.
Our net losses were $193.5 million, $80.7 million, and $71.0 million for the years ended December 31, 2024, 2023 and 2022, respectively. As of December 31, 2024, we had an accumulated deficit of $891.1 million.
Our net losses were $265.9 million, $193.5 million, and $80.7 million for the years ended December 31, 2025, 2024 and 2023, respectively.
The net loss for 2023 comprises of a loss of $4.5 million from the change in the fair value of the Conversion Option Derivative Liability and $0.9 million related to royalty fees under the Barings Credit Agreement that we paid or accrued, partially offset by a gain of $0.2 million from the change in the fair value of the Royalty Fee Derivative Liability.
The net loss for the year ended December 31, 2025 was comprised of a loss of $0.7 million from the change in the fair value of the Royalty Fee Derivative Liability, and an expense of $1.8 million related to royalty fees under the Barings Credit Agreement that we paid or accrued.
Net cash provided by financing activities for the year ended December 31, 2022 was $1.5 million and consisted of proceeds from the issuance of common stock pursuant to our employee stock purchase plan of $0.9 million and proceeds from the exercise of stock options of $0.5 million.
Net cash provided by financing activities for the year ended December 31, 2025 was $561.7 million and consisted of total net proceeds from the 2025 Offering of $445.6 million, total net proceeds from the issuance of common stock under the 2021 Sales Agreement of $94.0 million, proceeds from the exercise of stock options of $20.5 million, and proceeds from issuing shares under our ESPP, of $1.6 million.
Our net product revenue was $63.5 million for the year ended December 31, 2024, reflecting an increase of $5.6 million or 9.7% over the year ended December 31, 2023.
Our net product revenue was $51.8 million for the year ended December 31, 2025, reflecting a decrease of $11.6 million or 18.3% over the year ended December 31, 2024.
The total net proceeds of the public offering to us were approximately $107.7 million, after deducting underwriting discounts and commissions and other offering expenses payable by us.
The total net proceeds of the public offering to us were approximately $107.7 million, after deducting underwriting discounts and commissions and other offering expenses payable by us. In August 2023, we borrowed $82.5 million under the Barings Credit Facility and received proceeds of $77.3 million, after the application of an original issue discount and fees.
Operating lease commitments represent payments due under our leases of office, laboratory and manufacturing space in Bedford, Massachusetts that expire in July 2027 and July 2028, and leases of equipment that expire between 2026 and 2028. The commitments under the Barings Credit Agreement represent repayment of principal only.
These contracts generally provide for termination on notice, and therefore are cancelable contracts which are not included in contractual obligations and commitments. Operating lease commitments represent payments due under our leases of office, laboratory and manufacturing space in Bedford, Massachusetts that expire in July 2027 and July 2028, and leases of equipment that expire between 2026 and 2028.
Net cash provided by net favorable changes in our operating assets and liabilities during the year ended December 31, 2022 consisted primarily of increases of accrued expenses of $1.6 million, partially offset by decreases of other items, net, of $0.3 million. Investing activities.
Net cash provided by net favorable changes in our operating assets and liabilities during the year ended December 31, 2025 consisted primarily of increases of accrued expenses and other liabilities of $5.2 million, resulting primarily from employee compensation-related accruals as well as accruals related to our clinical development, decreases of prepaid expenses and other current assets of $2.6 million, and decreases of accounts receivable of $1.7 million, resulting from decreased net sales of DEXTENZA, partially offset by decreases of accounts payable of $0.9 million and other changes, net, of $1.0 million.
We anticipate that our research and development expenses will increase in the future as we support our continued development of our product candidates.
We anticipate that our research and development expenses will increase in the future as we support our continued development of our product candidates. Selling and Marketing Expenses Selling and marketing expenses consist primarily of salaries and related costs, including stock-based compensation, for personnel in selling and marketing functions as well as consulting, advertising and promotion costs.
General and administrative expenses also include insurance, facility-related costs and professional fees for legal, patent, consulting and accounting and audit services. Other Income (Expense) Interest Expense . Interest expense is incurred on our debt.
General and Administrative Expenses General and administrative expenses consist primarily of salaries and related costs, including stock-based compensation, for personnel in executive, finance, information technology, human resources and administrative functions. General and administrative expenses also include insurance, facility-related costs and professional fees for legal, patent, consulting and accounting and audit services. Other Income (Expense) Interest Income.
We calculate rebate payment amounts due under this program quarterly, based on actual qualifying purchases and apply a contractual discount rate.
Purchaser/Provider Discounts and Rebates —We offer rebate payments for which ASCs, HOPDs and other prescribers qualify by meeting quarterly purchase volumes of DEXTENZA under our volume-based rebate program. We calculate rebate payment amounts due under this program quarterly, based on actual qualifying purchases and apply a contractual discount rate.
We expect to continue to incur losses in connection with our ongoing activities, particularly as we advance the clinical trials of our product candidates in development, including AXPAXLI, and increase our sales and marketing resources to support the commercialization of DEXTENZA and the potential launch of our product candidates, subject to receiving FDA approval.
As of December 31, 2025, we had an accumulated deficit of $1,157.0 million. 123 Table of Contents We expect to continue to incur losses in connection with our ongoing activities, particularly as we advance the clinical trials of our product candidates in development, specifically the SOL-1, SOL-R and HELIOS-3 trials, as we initiate new clinical trials, specifically the planned SOL-X trial and, if needed, the HELIOS-2 trial, and as we support the commercialization of DEXTENZA and the potential commercialization of our product candidates, subject to receiving FDA approval.
The increase of $45.7 million is related to timing and conduct of our various clinical trials for our product candidates, including the progression of the SOL-1 trial, which was fully randomized by December 2024, the initiation of the SOL-R trial, the completion of the HELIOS trial, and development activities related to our preclinical programs. 113 Table of Contents We expect that direct research and development expenses for our products and product candidates will increase significantly for 2025 as we progress with the SOL-1 and the SOL-R trials; complete our other ongoing clinical trials; and initiate any other clinical trials of our product candidates that we might determine in the future to conduct, partially offset by reduced costs related to preclinical programs as a result of the Strategic Restructuring.
The increase of $62.4 million is related to timing and conduct of our various clinical trials for our product candidates, including the progression of the SOL-1 trial, which was fully randomized by December 2024, the initiation of the SOL-R trial in June 2024 and its progression through 2025, the initiation of the HELIOS-3 trial in the fourth quarter of 2025, the completion of the HELIOS-1 trial in the first half of 2024, and development activities related to our preclinical programs.
The GTN Provisions relative to gross DEXTENZA product sales increased as a result of the changes in the OID and are expected to increase with any additional anticipated OID increases, and we expect that GTN Provisions relative to gross DEXTENZA product sales will remain at this increased level, or might increase further, for 2025 and beyond.
We expect that GTN Provisions relative to gross DEXTENZA product sales will remain at this increased level, or might increase further, for 2026 and beyond. Collaboration Revenue Our collaboration revenue was $0.1 million and $0.3 million for the years ended December 31, 2025 and 2024, respectively.
We did not offer or sell shares of our common stock under the 2021 Sales Agreement during the year ended December 31, 2024. During the year ended December 31, 2023, we sold 1,514,926 shares of common stock under the 2021 Sales Agreement, resulting in net proceeds to us, after accounting for issuance costs, of $9.5 million.
In June 2025, we sold 11,548,364 shares of our common stock under the 2021 Sales Agreement, resulting in gross proceeds to us of $96.8 million and net proceeds, after accounting for issuance costs, of $94.0 million.
We anticipate that the level of our general and administrative expenses, exclusive of the one-time charges related to restructuring activities, will increase for 2025, as we have recently strengthened, and will continue to further 114 Table of Contents strengthen, our leadership team and other certain functions that support our clinical trials of AXPAXLI, including the SOL-1 trial and the SOL-R trial, and our business in general.
We anticipate that our general and administrative expenses will increase for 2026 and beyond, as we continue to further strengthen certain functions and processes that support our clinical trials of AXPAXLI, including the SOL-1 trial, the SOL-R trial, the HELIOS-3 trial, and the planned SOL-X trial, manufacturing scale-up and potential commercial launch initiatives for AXPAXLI.
Concurrently with the increases of the WAC, and additionally at other points in time in 2024, we also increased the off-invoice discount, or OID, for DEXTENZA as part of our overall pricing strategy. The OID amounts are generally determined at the time of resale by SDs or direct sales to ASCs or physicians’ offices by us.
The actual OID amounts are generally determined at the time of resale by SDs or direct sales to ASCs or physicians’ offices by us. Effective January 1, 2026, we increased the OID.
We enter into contracts in the normal course of business to assist in the performance of our research and development activities and other services and products for operating purposes. These contracts generally provide for termination on notice, and therefore are cancelable contracts which are not included in contractual obligations and commitments.
Because these estimates and assumptions are necessarily subjective, the amounts we will actually pay in future periods may vary from those reflected in the table. 127 Table of Contents We enter into contracts in the normal course of business to assist in the performance of our research and development activities and other services and products for operating purposes.
The increase was primarily due to an increase of $0.6 million in professional fees, an increase in facility-related and other costs of $0.3 million, and an increase in personnel costs, including stock-based compensation, of $0.1 million. We expect our selling and marketing expenses to remain stable or increase slightly for 2025 as we continue to support the commercialization of DEXTENZA.
The increase was primarily due to an increase in personnel costs, including stock-based compensation of $5.9 million, primarily related to the expansion of our commercial team for AXPAXLI, an increase in $5.4 million in 121 Table of Contents professional fees, including costs related to corporate branding and pre-commercial activities for AXPAXLI, and an increase in other costs of $1.0 million.
Collaboration Revenue We recognized $0.3 million of collaboration revenue related to the performance obligation under our license agreement with AffaMed to conduct a Phase 2 clinical trial of PAXTRAVA during the year ended December 31, 2024 compared to $0.6 million in the year ended December 31, 2023.
All of our collaboration revenue was attributable to the performance obligation under our license agreement with AffaMed to conduct a Phase 2 clinical trial of OTX-TIC, which we fully satisfied in 2025. We recognize collaboration revenue based on a cost-to-cost method.
The Medicare Statute allows for continued separate payment of DEXTENZA in the ASC setting for 2025, and it re-establishes the separate payment of DEXTENZA in the HOPD setting that was lost for 2024. Additionally, the Medicare Statute limits the separate payment for physician administered non-opioid pain medications.
The Medicare Statute limits the separate payment for physician administered non-opioid pain medications.
Net cash used in investing activities was $3.7 million for the year ended December 31, 2022, consisting of cash used to purchase property and equipment. Financing activities.
Net cash used in investing activities was $11.9 million for the year ended December 31, 2025, consisting of $11.4 million in cash used to purchase property and equipment and to make leasehold improvements for the scale-up of AXPAXLI manufacturing, and $0.6 million in cash used to purchase other items of property and equipment to support ongoing operations, partially offset by $0.1 million cash received from the sale of obsolete items of property and equipment.
In November 2024, the Centers for Medicare & Medicaid Services, or CMS, released the final Medicare Physician Fee Schedule, or MPFS, for the calendar year 2025, which results in a marginal decrease in physician payments for DEXTENZA. Effective January 2025, a clinician’s cost for DEXTENZA is included in the cost performance category of CMS’ Merit-based Incentive Payment System, or MIPS.
In October 2025, the Centers for Medicare & Medicaid Services, or CMS, released the final Medicare Physician Fee Schedule, or MPFS, for the calendar year 2026, or the CY 2026 MPFS, which resulted in a marginal decrease in physician payments compared to 2025 to $27.53 in the ASCs and HOPDs and a marginal increase compared to 2025 to $38.94 in the physician’s office for unilateral insertion.
Interest expense was $13.6 million and $11.3 million for the years ended December 31, 2024 and 2023, respectively, reflecting an increase of $2.2 million year-over-year.
Interest expense was $11.8 million and $13.6 million for the years ended December 31, 2025 and 2024, respectively, reflecting a decrease of $1.7 million year-over-year. The decrease is primarily due to lower average balances of debt outstanding as a result of the conversion of the Convertible Notes of $37.5 million in March 2024. Change in Fair Value of Derivative Liabilities.
We intend to meet with the FDA in the first half of 2025 to discuss the design of a potential registrational clinical program for AXPAXLI for the treatment of NPDR and DME and then evaluate our next steps.
AXPAXLI for the treatment of diabetic retinal disease We have initiated our registrational program for AXPAXLI for the treatment of diabetic retinal disease with the HELIOS-3 superiority clinical trial for the treatment of NPDR in November 2025.
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We intend to meet with the U.S. Food and Drug Administration, or FDA, in the first half of 2025 to discuss the design of a potential registrational clinical program for AXPAXLI for the treatment of NPDR and diabetic macular edema, or DME, and then evaluate our next steps.
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We also leverage the ELUTYX technology in our commercial product DEXTENZA, a corticosteroid approved by the U.S.
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Key Business and Financial Developments AXPAXLI for the treatment of wet AMD In December 2024, the SOL-1 trial, our first registrational Phase 3 clinical trial of AXPAXLI for the treatment of wet AMD, completed randomization of more than 300 evaluable treatment-naïve subjects with a diagnosis of wet AMD in the study eye.
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We are currently evaluating next steps for the OTX-TIC program.
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On January 14, 2025, we announced that, as of January 10, 2025, we had enrolled 311 subjects across various stages of loading and randomization in the SOL-R trial, our repeat-dosing registrational Phase 3 clinical trial of AXPAXLI for the treatment of wet AMD.

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Item 7A. Quantitative and Qualitative Disclosures About Market Risk

Market Risk — interest-rate, FX, commodity exposure

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Biggest changeExpected cash outflows from this financial instrument fluctuate based on changes in the Secured Overnight Financing Rate, or SOFR, which is, among other factors, affected by the general level of U.S. and international central bank 123 Table of Contents interest rates.
Biggest changeExpected cash outflows from this financial instrument fluctuate based on changes in the Secured Overnight Financing Rate, or SOFR, which is, among other factors, affected by the general level of U.S. and international central bank interest rates.
As of December 31, 2024, a 10% increase or decrease of the interest rate used in the valuation model would not have a material effect on the fair value of the Royalty Fee Derivative Liability. Changes of the fair value of the Royalty Fee Derivative Liability have no impact on anticipated cash outflows. ​
As of December 31, 2025, a 10% increase or decrease of the interest rate used in the valuation model would not have a material effect on the fair value of the Royalty Fee Derivative Liability. Changes of the fair value of the Royalty Fee Derivative Liability have no impact on anticipated cash outflows. ​
As of December 31, 2024, we had a secured term loan facility with a principal amount of $82.5 million under a credit and security agreement with Barings Finance LLC and the lenders party thereto, or the Barings Credit Agreement.
As of December 31, 2025, we had a secured term loan facility with a principal amount of $82.5 million under a credit and security agreement with Barings Finance LLC and the lenders party thereto, or the Barings Credit Agreement.
As of December 31, 2024, an immediate 100 basis point increase or decrease in the SOFR would not have a material effect on the anticipated cash outflows from this instrument.
As of December 31, 2025, an immediate 100 basis point increase or decrease in the SOFR would not have a material effect on the anticipated cash outflows from this instrument.
We account for the obligation to pay royalty fees embedded in the Barings Credit Agreement as a separate financial instrument, measured at fair value, using a Monte Carlo simulation, which we refer to as the Royalty Fee Derivative Liability. As of December 31, 2024, the Royalty Fee Derivative Liability was valued at $13.2 million.
We account for the obligation to pay royalty fees embedded in the Barings Credit Agreement as a separate financial instrument, measured at fair value, using a Monte Carlo simulation, which we refer to as the Royalty Fee Derivative Liability. As of December 31, 2025, the Royalty Fee Derivative Liability was valued at $13.9 million.
Item 7A. Quantitative and Qualitative Disclosures About Market Risk We are exposed to market risk related to changes in interest rates. As of December 31, 2024, we had cash and cash equivalents of $392.1 million, which includes cash in operating bank accounts, and investments in money market funds.
Item 7A. Quantitative and Qualitative Disclosures About Market Risk We are exposed to market risk related to changes in interest rates. As of December 31, 2025, we had cash and cash equivalents of $737.1 million, which includes cash in operating bank accounts, and investments in money market funds.

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