OCULAR THERAPEUTIX, INC

Previous wording

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 on our ELUTYX proprietary bioresorbable hydrogel-based formulation technology. AXPAXLI is currently in Phase 3 clinical trials for wet age-related macular degeneration, or wet AMD, with a Phase 3 clinical program for non-proliferative diabetic retinopathy, or NPDR, planned to be initiated imminently.

Current wording

We are an integrated biopharmaceutical company committed to redefining the retina experience. AXPAXLI, also known as OTX-TKI, our investigational, bioresorbable, intravitreal hydrogel incorporating axitinib, a small molecule, multi-target, tyrosine kinase inhibitor with anti-angiogenic properties. 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.

Previous wording

We also leverage the ELUTYX technology in our commercial product DEXTENZA, a corticosteroid approved by the U.S. 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 investigational 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 are currently evaluating next steps for the OTX-TIC program.

Current wording

We also leverage the ELUTYX technology in our commercial product DEXTENZA, a corticosteroid approved by the U.S. 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 are evaluating next steps for the OTX-TIC program.

Previous wording

We are currently conducting the SOL-1 trial, a repeat-dosing registrational Phase 3 clinical trial, to assess the safety and efficacy of AXPAXLI in subjects with wet AMD. The SOL-1 trial is designed as a prospective, multi-center, double-masked, randomized (1:1), parallel-group, two-arm superiority trial comparing a single injection of AXPAXLI with a drug load of 450 µg of axitinib, or AXPAXLI 450 µg, to a single injection of aflibercept 2 mg.

Current wording

In February 2026, we announced positive topline Week 52 results for the SOL-1 trial, a repeat-dosing registrational Phase 3 clinical trial, to assess the safety and efficacy of AXPAXLI in subjects with wet AMD. The SOL-1 trial is designed as a prospective, multi-center, double-masked, randomized (1:1), parallel-group, two-arm superiority trial comparing a single injection of AXPAXLI with a drug load of 450 µg of axitinib, or AXPAXLI 450 µg, to a single injection of aflibercept 2 mg.

Previous wording

The SOL-1 trial involves more than 100 trial sites located in the United States and Argentina. The SOL-1 trial completed the randomization of 344 subjects with a diagnosis of active macular choroidal neovascularization at screening in December 2024. Under the trial protocol, subjects were eligible for enrollment in the SOL-1 trial if they were treatment-naïve for wet AMD in the study eye; had central subfield thickness, or CSFT, of less than or equal to 500 microns; and had a Best Corrected Visual Acuity, or BCVA, of at least 54 letters as measured by the Early Treatment of Diabetic Retinopathy Study, or ETDRS, letters chart (approximately 20/80 Snellen equivalent vision). After screening, enrolled subjects received two aflibercept 2 mg loading doses at Weeks -8 and -4. Subjects reaching either a BCVA of greater than or equal to 84 ETDRS letters (approximately 20/20 Snellen equivalent vision) or experiencing an improvement of at least 10 ETDRS letters with a reduction in CSFT to no greater than 350 microns after these injections were randomized in the trial.

Current wording

The SOL-1 trial involves more than 100 trial sites located in the United States and Argentina. In December 2024, the SOL-1 trial completed the randomization of 344 subjects with a diagnosis of wet AMD in the study eye at screening. Under the trial protocol, subjects were eligible for enrollment in the SOL-1 trial if they were treatment-naïve for wet AMD in the study eye; had central subfield thickness, or CSFT, of less than or equal to 500 microns; and had a Best Corrected Visual Acuity, or BCVA, of at least 54 letters as measured by the Early Treatment of Diabetic Retinopathy Study, or ETDRS, letters chart (approximately 20/80 Snellen equivalent vision). After initial screening, every enrolled subject received two aflibercept 2 mg loading doses between the screening visit and Day 1: one at Week -8 and another at Week -4. Subjects reaching either a BCVA of greater than or equal to 84 ETDRS letters (approximately 20/20 Snellen equivalent vision) or experiencing an improvement of at least 10 ETDRS letters with a reduction in CSFT to no greater than 350 microns in the study eye after these injections were randomized in the trial on Day 1 (Baseline).

Previous wording

Retention in the trial continues to be outstanding, with greater than 95% of randomized subjects remaining on-trial to date, and rescues reviewed under masking shows greater than 95% of rescue events to date have met pre-established protocol-defined criteria. Oversight by an independent data and safety monitoring committee has not identified any safety signals in the SOL-1 trial to date.

Current wording

Retention in the SOL-1 trial continues to be outstanding, with greater than 95% of randomized subjects remaining on trial to date, and rescues reviewed under masking show greater than 95% of rescue events to date have met pre-established protocol defined criteria. All subjects have completed their Week 52 visit and have been re-dosed according

Previous wording

The primary endpoint of the SOL-1 trial is the proportion of subjects who maintain visual acuity, defined as a loss of fewer than 15 ETDRS letters from baseline, at Week 36. One of the secondary endpoints being evaluated is the proportion of subjects who maintain visual acuity measured at Week 52. At Weeks 52 and 76, all subjects that were randomized in the trial at Day 1, including subjects who previously received supplemental anti-vascular endothelial growth factor, or anti-VEGF treatment, are re-dosed with their respective initial treatment of a single injection of

Current wording

The primary endpoint of the SOL-1 trial is the proportion of subjects who maintained visual acuity, defined as a loss of fewer than 15 ETDRS letters from baseline, at Week 36. One of the key secondary endpoints is the proportion of subjects who maintained visual acuity measured at Week 52. At Weeks 52 and 76, all subjects that were randomized in the trial at Day 1, including subjects who previously received supplemental anti-vascular endothelial growth factor, or anti-VEGF treatment, are eligible to be re-dosed with their respective initial treatment of a single injection of AXPAXLI 450 μg in the investigational arm or a single injection of aflibercept 2 mg in the control arm.

Previous wording

We are conducting the SOL-1 trial in accordance with a special protocol assessment, or SPA, agreement with the FDA. We continue to expect topline results for the SOL-1 trial to be available in the first quarter of 2026 after the completion of the Week 52 visits for all subjects in the trial.

Current wording

We are conducting the SOL-1 trial in accordance with a special protocol assessment, or SPA, agreement with the FDA.

Previous wording

We are also conducting the SOL-R trial, a repeat-dosing registrational Phase 3 clinical trial to evaluate the non-inferiority of AXPAXLI 450 μg dosed every 24 weeks for the treatment of wet AMD compared to aflibercept 2 mg dosed on-label every eight weeks. The SOL-R trial includes sites located in the U.S., Argentina, India, and Australia. The SOL-R trial is designed as a multi-center, double-masked, randomized (2:2:1), three-arm trial and is intended to randomize approximately 555 subjects that are either treatment naïve or have been diagnosed with wet AMD in the study eye within about four months prior to enrollment. To qualify for screening in the SOL-R trial, a subject’s study eye must have a BCVA of at least 34 ETDRS letters (approximately 20/200 Snellen equivalent vision).

Current wording

We are also conducting the SOL-R trial, a repeat-dosing registrational Phase 3 clinical trial to evaluate the non-inferiority of AXPAXLI 450 μg dosed every 24 weeks for the treatment of wet AMD compared to aflibercept 2 mg dosed on-label every eight weeks. The SOL-R trial includes sites located in the U.S., Argentina, India, and Australia. The SOL-R trial is designed as a multi-center, double-masked, randomized (2:2:1), three-arm trial requiring subjects that were either treatment naïve or have been diagnosed with wet AMD in the study eye within about four months prior to screening. To qualify for screening in the SOL-R trial, a subject’s study eye must have had a BCVA of at least 34 ETDRS letters (approximately 20/200 Snellen equivalent vision).

Previous wording

Over the six months prior to randomization, enrolled subjects are given three screening doses of any anti-VEGF therapy, excluding brolucizumab-dbll, and monitored to exclude subjects demonstrating early persistent fluid or significant retinal fluid fluctuations. Subjects maintaining a CSFT of no greater than 350 microns at Weeks -12 and -8 and not experiencing a CSFT increase of greater than 35 microns from their lowest CSFT at any prior visit then receive two loading doses of aflibercept 2 mg at Weeks -8 and -4 prior to randomization.

Current wording

Over the six month screening and lead-in period prior to Baseline (Day 1) randomization, enrolled subjects were given three screening doses and two loading doses of any anti-VEGF therapy, excluding brolucizumab-dbll, and monitored to exclude subjects demonstrating early persistent fluid or significant retinal fluid fluctuations. Subjects maintaining a CSFT of no greater than 350 microns at Weeks -12 and -8, and not experiencing a CSFT increase of greater than 35 microns at Week -8 from their lowest CSFT at any prior visit, then received two loading doses of aflibercept 2 mg at Weeks -8 and -4 prior to randomization on Day 1.

Previous wording

Subjects in the first arm of the SOL-R trial receive a single dose of AXPAXLI 450 μg at Day 1 and are re-dosed at Weeks 24, 48, and 72. Subjects in the second arm receive aflibercept 2 mg on-label every eight weeks. Subjects in the third arm receive a single dose of aflibercept 8 mg at Day 1 and are re-dosed at Weeks 24, 48, and 72.

Current wording

Subjects in the first arm of the SOL-R trial received a single dose of AXPAXLI 450 μg at Day 1 and are re-dosed with AXPAXLI 450 μg at Weeks 24, 48, and 72. Subjects in the second arm received aflibercept 2 mg on Day 1 and per label every eight weeks thereafter. Subjects in the third arm received a single dose of aflibercept 8 mg at Day 1 and are re-dosed at Weeks 24, 48, and 72. Subjects will be followed for safety until Week 96. Trial subjects and designated trial personnel will remain masked through the end of Week 96.

Previous wording

The primary endpoint of SOL-R is to demonstrate non-inferiority in mean BCVA change from baseline between the AXPAXLI and on-label aflibercept 2 mg arms at Week 56. The third arm of the SOL-R trial, which has only been included for masking purposes, is not part of the non-inferiority analysis. Based on FDA guidance, the non-inferiority margin for the lower bound for the trial has been established at -4.5 letters of mean BCVA.

Current wording

The primary endpoint of the SOL-R trial is to demonstrate non-inferiority in mean BCVA change from baseline between the AXPAXLI and on-label aflibercept 2 mg arms at Week 56. The third arm (aflibercept 8 mg) of the SOL-R trial, which has only been included for masking purposes, is not part of the non-inferiority analysis. Based on FDA guidance, the non-inferiority margin for the lower bound for the trial has been established at -4.5 letters of mean BCVA.

Previous wording

In a written Type C response received in August 2024, and a subsequent written response received in December 2024, the FDA agreed that the SOL-R repeat dosing wet AMD trial, with a primary endpoint at Week 56, should be appropriate as an adequate and well-controlled trial in support of a potential new drug application, or NDA, and for a product label for AXPAXLI for the treatment of wet AMD. The FDA also noted that the use of one superiority trial and one non-inferiority trial is generally acceptable as the basis of an eventual NDA in wet AMD.

Current wording

In a written Type C response received in August 2024, and a subsequent written response received in December 2024, the FDA agreed that the SOL-R repeat dosing wet AMD trial, with a primary endpoint at Week 56, should be appropriate as an adequate and well-controlled trial in support of a potential new drug application, or NDA, and for a potential product label for AXPAXLI for the treatment of wet AMD. The FDA also noted that the use of one superiority trial and one non-inferiority trial is generally acceptable as the basis of an eventual NDA in wet AMD.

Previous wording

On November 4, 2025, we announced that the SOL-R trial has achieved its randomization target of 555 subjects. We will continue to allow randomization of previously enrolled subjects currently in the loading phase of the trial to maintain our commitment to both patients and investigators, with topline data remaining on track for the first half of 2027.

Current wording

On November 4, 2025, we announced that the SOL-R trial achieved its randomization target of 555 subjects. We continued to allow randomization of previously enrolled subjects that were still in the loading phase when we achieved target randomization to maintain our commitment to both patients and investigators. We have now completed randomization of the SOL-R trial with a total of 631 subjects randomized. Subject retention in the SOL-R trial remains high. Topline data for the SOL-R trial are expected to be available in the first quarter of 2027.

Previous wording

We plan to initiate a long-term, multi-center, open-label extension clinical trial, which we refer to as the SOL-X trial, to evaluate subjects who have completed their two-year safety follow-up visits in either the SOL-1 or SOL-R trials for an additional three years. The primary objectives of the planned SOL-X trial are to evaluate the long-term safety of AXPAXLI; to explore long-term visual outcomes, including visual acuity and the incidence and/or progression of fibrosis and macular atrophy; and to evaluate the impact of delayed initiation of AXPAXLI in patients who initially were randomized to receive aflibercept in either SOL-1 or SOL-R. According to the planned trial design, subjects enrolled in

Current wording

In April 2026, the first patient was enrolled in the SOL-X trial, a multi-center, open-label, long-term safety extension clinical trial to evaluate subjects who have completed their two-year safety follow-up visits in either the SOL-1 or SOL-R trial for an additional three years. The primary objectives of the SOL-X trial are to evaluate the long-term safety of AXPAXLI; to explore long-term visual outcomes, including visual acuity and the incidence and/or progression of fibrosis and macular atrophy; and to evaluate the impact of delayed initiation of AXPAXLI in patients who initially were randomized to receive aflibercept in either the SOL-1 or SOL-R trial. Subjects enrolled in the SOL-X trial will receive AXPAXLI 450 μg every 24 weeks and are to be evaluated at Week 4, Week 12, and every 12 weeks thereafter.

Previous wording

If we obtain favorable results from the SOL-1 trial and the SOL-R trial, we plan to submit an NDA with the FDA for marketing approval of AXPAXLI for the treatment of wet AMD. Because axitinib is FDA-approved for non-ophthalmic indications, we plan to leverage the 505(b)(2) NDA review pathway which has the potential to shorten the review timeline for AXPAXLI by two months compared to the traditional review pathway for new molecular entities. If approved, we believe AXPAXLI has the potential to be the first product for wet AMD with a superiority label as compared to a single injection of anti-VEGF based on the SOL-1 trial, with redosing potentially as infrequently as every 12 months.

Current wording

We plan to submit an NDA with the FDA for marketing approval of AXPAXLI for the treatment of wet AMD based on the Week 52 data from the SOL-1 trial, subject to ongoing formal discussions with the FDA. Because axitinib is FDA-approved for non-ophthalmic indications, we plan to leverage the 505(b)(2) NDA review pathway which has the potential to shorten the review timeline for AXPAXLI by up to two months compared to the traditional review pathway for new molecular entities. If approved, AXPAXLI would be the first tyrosine kinase inhibitor commercialized for the

Previous wording

In September 2025, we announced plans to initiate two superiority registrational trials of AXPAXLI for the treatment of NPDR, which we refer to as the HELIOS-2 and HELIOS-3 trials. We plan to target a broad label in DR by including subjects with non-center-involved DME, or non-CI-DME. We are preparing to initiate the HELIOS registrational program imminently with the goal of evaluating 6- and 12-month dosing intervals.

Current wording

In September 2025, we announced plans for two superiority registrational trials of AXPAXLI for the treatment of NPDR, which we refer to as the HELIOS-2 and HELIOS-3 trials. We plan to target a broad label in diabetic retinopathy, or DR, by including subjects with non-center-involved diabetic macular edema, or non-CI-DME.

Previous wording

The HELIOS-2 and HELIOS 3 trials will leverage a novel ordinal primary endpoint of 2 or more steps on the DRSS. Historically, DR trials have relied on binary endpoints measuring either an improvement of 2 or more steps in DRSS or the prevention of a 2 or more step DRSS worsening have been used as binary endpoints. The HELIOS program will be the first time an ordinal endpoint is being used in DR trials, which means the statistical analysis will measure changes across the DRSS spectrum, including disease improvement, stability, and worsening. These are all clinically meaningful measures for retina specialists in the context of a disease that gets progressively worse if untreated. The use of the novel ordinal endpoint means that every patient will contribute data to the statistical analysis, allowing for a smaller trial size to achieve statistically significant outcomes relative to the size required for a binary analysis. We believe the ordinal DRSS endpoint enables a higher probability of success with smaller, shorter, more relevant, and less expensive trials, relative to other potential endpoints.

Current wording

The potential HELIOS-2 trial and the ongoing HELIOS-3 trial are designed to leverage a novel ordinal primary endpoint of 2 or more steps on the diabetic retinopathy severity scale, or DRSS. Historically, DR trials have relied on binary endpoints measuring either an improvement of 2 or more steps in DRSS or the prevention of a 2 or more step DRSS worsening. The HELIOS program is the first time an ordinal endpoint is being used in a DR trial, which means the statistical analysis will measure changes across the DRSS spectrum, including disease improvement, stability, and worsening. These are all clinically meaningful measures for retina specialists in the context of a disease that gets progressively worse if untreated. The use of the novel ordinal endpoint means that every patient will contribute data to the statistical analysis, allowing for a smaller trial size to achieve statistically significant outcomes relative to the size required for a binary analysis. We believe the ordinal DRSS endpoint enables a higher probability of success with smaller, shorter, more relevant, and less expensive trials, relative to other potential endpoints.

Previous wording

We also plan to initiate the HELIOS-3 trial, a second Phase 3 clinical trial to evaluate the safety and efficacy of AXPAXLI in approximately 930 subjects with moderately severe to severe NPDR without CI-DME. The planned HELIOS-3 trial is designed to be a multi-center, double-masked, randomized (1:1:1), three-arm superiority trial comparing two dosing regimens of AXPAXLI to a sham comparator. Similar to the HELIOS-2 trial, the HELIOS-3 clinical trial is also expected to include subjects with non-CI-DME.

Current wording

On November 24, 2025, we announced that the first subject in the HELIOS-3 trial was randomized. The ongoing HELIOS-3 trial is evaluating the safety and efficacy of AXPAXLI and is intended to randomize approximately 930 subjects with moderately severe to severe NPDR without center-involved diabetic macular edema, or CI-DME. The HELIOS-3 trial is a multi-center, double-masked, randomized (1:1:1), three-arm superiority trial comparing two dosing regimens of AXPAXLI 450 μg to a sham comparator.

Previous wording

The primary endpoint of the HELIOS-2 clinical trial is subjects’ ordinal 2-step DRSS change status from baseline—comparing whether subjects have experienced at least a two-step improvement, at least a two-step worsening, or less than a two-step change in either direction—assessed at Week 52.

Current wording

In February 2026, we amended the HELIOS-3 trial protocol to, among other things, extend the primary endpoint assessment from Week 52 to Week 56, update the subject assessment schedule to approximately every four weeks through Week 56 and every eight weeks thereafter through Week 96. The primary endpoint of the HELIOS-3 clinical trial is subjects' ordinal 2-step DRSS change status from baseline, comparing whether subjects have experienced at least a two-step improvement, at least a two-step worsening, or less than a two-step change in either direction, assessed at Week 56.

Previous wording

According to the planned trial design, eligible subjects in the HELIOS-3 trial will be randomized as follows: subjects in the first arm will receive a single injection of AXPAXLI 450 μg at Day 1 and will be re-dosed with AXPAXLI 450 μg at Week 24; subjects in the second arm will receive a single injection of AXPAXLI 450 μg at Day 1 and a sham injection at Week 24; and subjects in the third arm will receive sham injections at both Day 1 and Week 24. Subjects will be assessed every three months throughout the trial, and subjects and designated trial personnel will remain masked through the end of Week 52.

Current wording

Eligible subjects in the HELIOS-3 trial are randomized as follows: subjects in the first arm will receive a single injection of AXPAXLI 450 μg at Day 1 and will be re-dosed with AXPAXLI 450 μg at Weeks 24, 48 and 72; subjects in the second arm will receive a single injection of AXPAXLI 450 μg at Day 1 and Week 48, and a sham injection at Weeks 24, and 72; and subjects in the third arm will receive sham injections at Day 1, and Weeks 24, 48 and 72. Subjects will be assessed every four weeks through Week 56, and every eight weeks thereafter through Week 96. The study subjects and designated trial personnel will remain masked through the end of Week 96.

Previous wording

approximately 432 subjects with moderately severe to severe NPDR without center-involved DME, or CI-DME. The planned HELIOS-2 trial is designed to be a multi-center, double-masked, randomized (1:1), parallel-group, two-arm superiority trial comparing a single injection of AXPAXLI 450 μg to a single injection of ranibizumab 0.3 mg. The trial is expected to include subjects with non-CI-DME.

Current wording

The HELIOS-2 trial is designed to evaluate the safety and efficacy of AXPAXLI in approximately 432 subjects with moderately severe to severe NPDR without CI-DME. This multi-center, double-masked, superiority trial is designed to randomize subjects (1:1), in parallel-groups comparing a single injection of AXPAXLI 450 μg to a single injection of ranibizumab 0.3 mg. We expect that this trial would also include subjects with non-CI-DME.

Previous wording

According to the planned trial design, eligible subjects in the HELIOS-2 trial will be randomized to receive either a single dose of AXPAXLI 450 μg or a single dose of ranibizumab. At Week 52, all subjects that were randomized in the trial will be re-dosed with their respective initial treatments. Subjects will be assessed monthly through Year 1 and every other month thereafter for safety through the end of Year 2. Subjects and designated trial personnel will remain masked through the end of Year 2.

Current wording

According to the planned trial design, eligible subjects in the HELIOS-2 trial would be randomized to receive either a single dose of AXPAXLI 450 μg or a single dose of ranibizumab 0.3mg. At Week 52, all subjects would be re-dosed with their respective initial assigned study treatments at Day 1. Subjects would be assessed monthly through Year 1 and every other month thereafter for safety through the end of Year 2. Subjects and designated trial personnel would remain masked through the end of Year 2.

Previous wording

The primary endpoint of the HELIOS-3 clinical trial is identical to the primary endpoint of the HELIOS-2 trial, subjects’ ordinal 2-step DRSS change status from baseline as assessed at Week 52.

Current wording

The primary endpoint of the HELIOS-2 trial would be identical to the primary endpoint of the HELIOS-3 trial, subjects' ordinal 2-step DRSS change status from baseline, but would be assessed at Week 52.

Previous wording

Demand for DEXTENZA is determined by In-Market Sales, defined as unit sales from the SDs to ASCs, HOPDs, and physicians’ offices, and unit sales made directly by us to ASCs and physicians’ offices. We recorded In-Market Sales of approximately 48,000 units in the three months ended September 30, 2025, an increase of approximately 6,000 units compared to the three months ended September 30, 2024, and an increase of approximately 4,000 units compared to the three months ended June 30, 2025. Differences between In-Market Sales figures and the number of units of DEXTENZA sold by us to SDs and through Direct Sales as included in net product revenue recognized in our unaudited condensed consolidated financial statements are attributable to distributor stocking patterns. We believe that clinicians are adjusting to the impact of MIPS, and together with our increased sales efforts directed towards HOPDs, which receive separate payment for DEXTENZA in 2025 after being ineligible for separate payments in 2024, we expect DEXTENZA unit growth to continue.

Current wording

Demand for DEXTENZA is determined by In-Market Sales, defined as unit sales from the SDs to ASCs, HOPDs, and physicians’ offices, and Direct Sales. We recorded In-Market Sales of approximately 42,000 units in the three months ended March 31, 2026, an increase of approximately 2,000 units compared to the three months ended March 31, 2025. Differences between In-Market Sales figures and the number of units of DEXTENZA sold by us to SDs and through Direct Sales as included in net product revenue recognized in our unaudited condensed consolidated financial statements are attributable to distributor stocking patterns. For the remainder of 2026, we expect to see continued revenue growth from increased sales efforts directed toward HOPDs, partially offset by a slightly higher gross to net adjustments based on the increases in OID described above.

Previous wording

Cost of product revenue consists of costs of DEXTENZA product revenue, which include:

Current wording

Cost of product revenue consists primarily of costs of DEXTENZA product revenue, which include:

Previous wording

Interest Expense. Interest expense is incurred on our debt. In August 2023, we entered into a credit and security agreement, or the Barings Credit Agreement, with Barings Finance LLC, or Barings, as administrative agent, and the lenders party thereto, providing for a secured term loan facility, or the Barings Credit Facility, in the aggregate principal amount of $82.5 million. For the three and nine months ended September 30, 2025, our interest-bearing debt included the Barings Credit Facility ($82.5 million outstanding principal). For the three months ended September 30, 2024, our interest-bearing debt included the Barings Credit Facility ($82.5 million outstanding principal). For the nine months ended September 30, 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).

Current wording

Interest Expense. Interest expense is incurred on our debt. In August 2023, we entered into a credit and security agreement, or the Barings Credit Agreement, with Barings Finance LLC, or Barings, as administrative agent, and the lenders party thereto, providing for a secured term loan facility, or the Barings Credit Facility, in the aggregate principal amount of $82.5 million. For the three months ended March 31, 2026 and 2025, our interest-bearing debt included the Barings Credit Facility ($82.5 million outstanding principal).

Previous wording

*Change in Fair Value of Derivative Liabilities.*In August 2023, in connection with entering into the Barings Credit Agreement, we identified an embedded derivative liability, which we were required to measure at fair value at inception and then are required to measure at the end of each reporting period until the embedded derivative is settled. In 2019, in connection with the issuance of our Convertible Notes, we identified an embedded derivative liability, which we were required to measure at fair value at inception and then at the end of each reporting period until the embedded derivative was settled. The settlement of the derivative liability related to the Convertible Notes occurred on March 28, 2024. The changes in fair value of these derivative liabilities are recorded through the condensed consolidated statements of operations and comprehensive loss and are presented under the caption “change in fair value of derivative liabilities”.

Current wording

*Change in Fair Value of Derivative Liabilities.*In August 2023, in connection with entering into the Barings Credit Agreement, we identified an embedded derivative liability, which we were required to measure at fair value at inception and then are required to measure at the end of each reporting period until the embedded derivative is settled. The change in fair value of any derivative liabilities are recorded through the unaudited condensed consolidated statements of operations and comprehensive loss and are presented under the caption “change in fair value of derivative liabilities”.

Previous wording

Our product revenue, net was $14.5 million and $15.3 million for the three months ended September 30, 2025 and 2024, respectively, reflecting a decrease of $0.8 million year-over-year. All of our product revenue, net, was attributable to sales of DEXTENZA.

Current wording

Our product revenue, net, was $10.8 million and $10.6 million for the three months ended March 31, 2026 and 2025, respectively, reflecting an increase of $0.2 million year-over-year. All of our product revenue, net, was attributable to sales of DEXTENZA.

Previous wording

Our total GTN Provisions for the three months ended September 30, 2025 and 2024 were 52.5% and 39.0%, respectively, of gross DEXTENZA product sales. We are required to estimate the expected GTN Provisions when we sell DEXTENZA to SDs, ASCs and physicians’ offices and accrue for them at that time. We adjust the OID, a significant component of the GTN Provisions for DEXTENZA from time to time and typically on a quarterly basis as part of our overall pricing strategy. 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 July 1, 2025, we increased the OID, and subsequently, effective October 1, 2025, we decreased the OID. The total GTN Provisions for the three months ended September 30, 2025 therefore include timing effects related to the decreased OID, as the estimated GTN Provisions for units that we sold to SDs during the three months ended September 30, 2025 under the pre-October 2025 OID and that were not sold as In-Market Sales during that period will be subject to the decreased OID. Compared to the three months ended September 30, 2024, the GTN Provisions relative to gross DEXTENZA product sales increased during the three months ended September 30, 2025, primarily as a result of the changes in the OID. We expect that GTN Provisions relative to gross DEXTENZA product sales will remain at this increased level, or might increase further, for the remainder of 2025 and beyond.

Current wording

Our total GTN Provisions for the three months ended March 31, 2026 and 2025 were 54.1% and 49.4%, respectively, of gross DEXTENZA product sales. We are required to estimate the expected GTN Provisions when we sell DEXTENZA to SDs, ASCs and physicians’ offices and accrue for them at that time. We adjust the OID, a significant component of the GTN Provisions for DEXTENZA from time to time and typically on a quarterly basis as part of our overall pricing strategy. The actual OID amounts are generally determined at the time of resale by SDs or direct sales to ASCs or physicians’ offices by us. Compared to the three months ended March 31, 2025, the GTN Provisions relative to gross DEXTENZA product sales increased during the three months ended March 31, 2026, primarily as a result of the changes in the OID. We expect that GTN Provisions relative to gross DEXTENZA product sales will remain at this increased level or may increase further, for the remainder of 2026 and beyond.

Previous wording

Within research and development expenses, expenses for clinical programs increased $17.8 million, unallocated expenses decreased $2.4 million, and expenses for preclinical programs decreased $0.1 million.

Current wording

Research and development expenses were $66.2 million and $42.9 million for the three months ended March 31, 2026 and 2025, respectively, reflecting an increase of $23.4 million year-over-year. Within research and development expenses, expenses for clinical programs increased $17.7 million, unallocated expenses increased $5.7 million, and expenses for preclinical programs remained constant.

Previous wording

For the three months ended September 30, 2025, we incurred $35.9 million in direct research and development expenses for our products and product candidates compared to $18.2 million for the three months ended September 30, 2024. The increase of $17.7 million is related to timing and conduct of our various clinical trials for our product candidates, including the progression of the SOL-1 trial and the SOL-R trial.

Current wording

For the three months ended March 31, 2026, we incurred $43.2 million in direct research and development expenses for our products and product candidates compared to $25.5 million for the three months ended March 31, 2025. The increase of $17.7 million is related to timing and scale of our various clinical trials for our product candidates, including the progression of the SOL-1, SOL-R, SOL-X and HELIOS-3 clinical trials as well as a one-time cost and the disposal of fixed assets as we transitioned back to the two-piece injector used in the SOL-1 trial to support a potential NDA filing based on SOL-1 Week 52 data.

Previous wording

We expect that direct research and development expenses for our products and product candidates will continue to increase significantly for the remainder of 2025 and beyond as we progress with the SOL-1 and the SOL-R trials; initiate the planned SOL-X, HELIOS-2, and HELIOS-3 trials; and perform increased activities regarding the pre-commercial manufacturing of AXPAXLI. We expect that personnel costs will continue to increase for the remainder of 2025 and beyond as we plan to hire additional personnel to support our planned clinical trials.

Current wording

We expect that direct research and development expenses for our products and product candidates will continue to increase significantly for the remainder of 2026 and beyond as we prepare for the planned NDA submission for AXPAXLI for wet AMD, progress the SOL-R trial toward topline data expected in the first quarter of 2027, enroll additional patients in the SOL-X and HELIOS-3 trials; and perform increased registration-enabling manufacturing scale-up activities for AXPAXLI. We expect that personnel costs will continue to increase for the remainder of 2026 and beyond as we plan to hire additional personnel to support our planned clinical trials, NDA preparation activities, and pre-commercial manufacturing scale-up.

Previous wording

Selling and marketing expenses were $13.1 million and $10.6 million for the three months ended September 30, 2025 and 2024, respectively, reflecting an increase of $2.5 million year-over-year.

Current wording

Selling and marketing expenses were $16.6 million and $14.1 million for the three months ended March 31, 2026 and 2025, respectively, reflecting an increase of $2.5 million year-over-year.

Previous wording

The increase is due to an increase in personnel-related costs, including stock-based compensation, of $1.4 million, primarily reflecting an increase related to the expansion of our marketing team for AXPAXLI; an increase in professional fees of $0.9 million, including costs related to our corporate branding; and an increase in facility-related and other costs of $0.2 million.

Current wording

The increase is due to an increase in personnel-related costs, including stock-based compensation, of $2.0 million, primarily reflecting the expansion of our pre-commercial team to prepare for a potential AXPAXLI wet AMD launch; an increase in professional fees of $0.1 million, including costs related to our corporate branding; and an increase in facility-related and other costs of $0.4 million with the associated headcount expansion.

Previous wording

We expect our selling and marketing expenses to increase for the remainder of 2025 and beyond as we continue to support the commercialization of DEXTENZA and initiate and continue marketing-related activities in connection with the potential commercial launch of AXPAXLI.

Current wording

We expect our selling and marketing expenses to increase for the remainder of 2026 and beyond as we continue to invest in additional AXPAXLI pre-launch activities and support ongoing DEXTENZA commercialization efforts.

Previous wording

The increase was due to an increase in personnel-related costs, including stock-based compensation, of $4.5 million and an increase in facility-related and other costs of $0.3 million, partially offset by a decrease in professional fees of $0.9 million. The increase in personnel-related costs, including stock-based compensation, primarily relates to increased stock-based compensation expenses of $4.0 million.

Current wording

The increase was due to an increase in personnel-related costs, including stock-based compensation, of $2.6 million, an increase in facility-related and other costs of $0.2 million, and an increase in professional fees of $0.9 million.

Previous wording

We anticipate that our general and administrative expenses will increase for the remainder of 2025 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, and our planned SOL-X, HELIOS-2, and HELIOS-3 trials.

Current wording

We anticipate that our general and administrative expenses will increase for the remainder of 2026 and beyond, as we continue to further strengthen operations and processes that support our clinical trials of AXPAXLI, including the SOL-1 trial, the SOL-R trial, the SOL-X trial and the HELIOS-3 trial.

Previous wording

Interest Income. Interest income was $3.7 million and $5.7 million for the three months ended September 30, 2025 and 2024, respectively, reflecting a decrease of $2.0 million year-over-year. The decrease is attributable primarily to a lower average balance of interest-generating cash and cash equivalents.

Current wording

Interest Income. Interest income was $6.1 million and $3.8 million for the three months ended March 31, 2026 and 2025, respectively, reflecting an increase of $2.3 million year-over-year. The increase is attributable primarily to a higher average balance of interest-generating cash and cash equivalents as a result of our October 2025 equity financing.

Previous wording

Interest Expense. Interest expense was $3.0 million and $3.2 million for the three months ended September 30, 2025 and 2024, respectively, reflecting a decrease of $0.2 million year-over-year.

Current wording

Interest Expense. Interest expense was $2.8 million and $3.0 million for the three months ended March 31, 2026 and 2025, respectively, reflecting a decrease of $0.2 million year-over-year.

Previous wording

*Change in Fair Value of Derivative Liabilities.*We recognized a net loss from the change in fair value of our derivative liability related to the Barings Credit Agreement of $1.4 million for the three months ended September 30, 2025. We recognized a net gain from the change in fair value of our derivative liability related to the Barings Credit Agreement of $7.1 million for the three months ended September 30, 2024. The net loss for the three months ended September 30, 2025 is comprised of a non-cash loss of $0.9 million from the change in the fair value of the derivative liability, and an expense of $0.5 million related to royalty fees under the Barings Credit Agreement that we paid or accrued. The net gain for the three months ended September 30, 2024 is comprised of a non-cash gain of $7.6 million from the change in the fair value of the derivative liability, partially offset by a $0.5 million expense related to royalty fees under the Barings Credit Agreement that we paid or accrued. We cannot predict how the fair value of the derivative liability related to the Barings Credit Agreement will change in the remainder of 2025 and beyond.

Current wording

*Change in Fair Value of Derivative Liabilities.*We recognized a net gain from the change in fair value of our derivative liability related to the Barings Credit Agreement of $1.5 million for the three months ended March 31, 2026. We recognized a net loss from the change in fair value of our derivative liability related to the Barings Credit Agreement of $1.0 million for the three months ended March 31, 2025. The net gain for the three months ended March 31, 2026 is comprised of a non-cash gain of $1.8 million from the change in the fair value of the derivative liability, partially offset by an expense of $0.4 million related to DEXTENZA royalty fees under the Barings Credit Agreement that we paid or accrued. The net loss for the three months ended March 31, 2025 is comprised of a non-cash loss of $0.6 million from the change in the fair value of the derivative liability and an expense of $0.4 million expense related to royalty fees under the Barings Credit Agreement that we paid or accrued. We cannot predict how the fair value of the derivative liability related to the Barings Credit Agreement will change in the remainder of 2026 and beyond.