OCULAR THERAPEUTIX, INC

Previous wording

The SOL-1 trial involves more than 100 trial sites located in the United States and Argentina. The primary endpoint of the SOL-1 trial is the proportion of subjects who maintained visual acuity at Week 36. One of the key secondary endpoints is the proportion of subjects who maintained visual acuity measured at Week 52. Subjects who were successfully randomized are assessed every month and will receive a supplemental dose of aflibercept 2 mg as needed based on pre-specified criteria. At Weeks 52 and 76, all subjects, including subjects who previously received supplemental rescue treatment, are to be re-dosed with their respective initial treatment of either a single injection of AXPAXLI 450 μg in the investigational arm or a single injection of aflibercept 2 mg in the control arm. In accordance with the trial design, subjects will be followed for safety, and subjects and designated trial personnel will remain masked, through Week 104.

Current wording

The SOL-1 trial involves more than 100 trial sites located in the United States and Argentina. The primary endpoint of the SOL-1 trial is the proportion of subjects who maintained visual acuity at Week 36. One of the key secondary endpoints is the proportion of subjects who maintained visual acuity measured at Week 52. Subjects who were successfully randomized are assessed every month and will receive a supplemental dose of aflibercept 2 mg as needed based on pre-specified criteria. At Weeks 52 and 76, all subjects, including subjects who previously received supplemental rescue treatment, were re-dosed with their respective initial treatment of either a single injection of AXPAXLI 450 μg in the investigational arm or a single injection of aflibercept 2 mg in the control arm. In accordance with the trial design, subjects will be followed for safety, and subjects and designated trial personnel will remain masked, through Week 104.

Previous wording

In February 2026, we announced positive topline Week 52 results for the SOL-1 trial. AXPAXLI met its primary endpoint with statistical significance. The proportion of subjects who maintained visual acuity, defined as a loss of fewer than 15 ETDRS letters from baseline, at Week 36 was 74.1% in the AXPAXLI arm compared to 55.8% in the aflibercept 2 mg arm, with a risk difference of 17.5% and a p-value of 0.0006 per the pre-specified statistical model, and with an observed difference of 18.3%. The risk difference is the difference in the probability of maintaining vision in the treatment arm compared to the control arm as per the pre-specified statistical model. The observed difference is the numerical difference of the observed event rate between the two arms.

Current wording

In February 2026, we announced positive topline Week 52 results for the SOL-1 trial. AXPAXLI met its primary endpoint with statistical significance. The proportion of subjects who maintained visual acuity, defined as a loss of fewer than 15 Early Treatment of Diabetic Retinopathy Study, or ETDRS, letters from baseline, at Week 36 was 74.1% in the AXPAXLI arm compared to 55.8% in the aflibercept 2 mg arm, with a risk difference of 17.5% and a p-value of 0.0006

Previous wording

AXPAXLI also met a key secondary pre-specified endpoint measuring the proportion of subjects who maintained visual acuity at Week 52, using the same analysis as the primary endpoint, with high statistical significance. The proportion of subjects who maintained vision at Week 52 was 65.9% in the AXPAXLI arm compared to 44.2% in the aflibercept 2 mg arm, with a risk difference of 21.1%, and a p-value of <0.0001 per the pre-specified statistical model compared to aflibercept 2 mg subjects, and with an observed difference of 21.7%.

Current wording

AXPAXLI also met a pre-specified key secondary endpoint measuring the proportion of subjects who maintained visual acuity at Week 52, using the same analysis as the primary endpoint, with high statistical significance. The proportion of subjects who maintained vision at Week 52 was 65.9% in the AXPAXLI arm compared to 44.2% in the aflibercept 2 mg arm, with a risk difference of 21.1%, and a p-value of <0.0001 per the pre-specified statistical model compared to aflibercept 2 mg subjects, and with an observed difference of 21.7%.

Previous wording

We evaluated the proportion of subjects who did not require rescue injections as specified by the SOL-1 trial protocol rescue criteria. The rescue-free rates in the AXPAXLI arm were 80.6%, 74.7%, and 68.8% at Weeks 24, 36, and 52, respectively, compared to 72.1%, 56.4%, and 47.7% in the aflibercept 2 mg arm at the same time periods. The observed differences were 8.5%, 18.3%, and 21.1% in favor of the AXPAXLI arm at Weeks 24, 36, and 52, respectively.

Current wording

We evaluated the proportion of subjects who did not require rescue injections as specified by the SOL-1 trial protocol rescue criteria. The rescue-free rates in the AXPAXLI arm were 80.6%, 74.7%, and 68.8% at Weeks 24, 36, and 52, respectively, compared to 72.1%, 56.4%, and 47.7% in the aflibercept 2 mg arm at the same time points. The observed differences were 8.5%, 18.3%, and 21.1% in favor of the AXPAXLI arm at Weeks 24, 36, and 52, respectively.

Previous wording

After aligning with the FDA at a Type C meeting held in May 2026 as to our submission plan, we anticipate submitting a new drug application, or NDA, to the FDA for marketing approval of AXPAXLI for the treatment of wet AMD during the fourth quarter of 2026. The NDA is expected to include the Week 52 efficacy and safety data from the SOL-1 trial, together with interim Week 52 safety data for a subset of subjects in the SOL-R trial and confirmatory evidence. To provide safety information for a minimum of 300 subjects in the aggregate with at least one year of treatment with AXPAXLI in accordance with FDA guidance and to supplement the 170 subjects who received AXPAXLI in the SOL-1 trial, we plan to conduct an interim safety analysis of the SOL-R trial during the fourth quarter of 2026 assessing all subjects who have completed the Week 52 time point at the time of analysis. SOL-R efficacy data is not part of our planned NDA submission.

Current wording

We anticipate submitting a new drug application, or NDA, to the FDA for marketing approval of AXPAXLI for the treatment of wet AMD during the fourth quarter of 2026. We held a Type C meeting in May 2026 and a pre-NDA meeting in September 2026 with the FDA to review our plans to submit our NDA and our expectations for the NDA submission package. The NDA is expected to include the Week 52 efficacy and safety data from the SOL-1 trial, together with interim Week 52 safety data for a subset of subjects in the SOL-R trial and confirmatory evidence. To provide safety information for a minimum of 300 subjects in the aggregate with at least one year of treatment with AXPAXLI in accordance with FDA guidance and to supplement the 170 subjects who received AXPAXLI in the SOL-1 trial, we plan to conduct an interim safety analysis of the SOL-R trial during the fourth quarter of 2026 assessing all subjects who have completed the Week 52 time point at the time of analysis. SOL-R efficacy data is not part of our planned NDA submission.

Previous wording

We are also conducting the SOL-R trial, a repeat-dosing 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).

Current wording

We are also conducting the SOL-R trial, a repeat-dosing 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 who 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 Best Corrected Visual Acuity, or BCVA, of at least 34 ETDRS letters (approximately 20/200 Snellen equivalent vision).

Previous wording

Over the six month screening and lead-in period prior to Baseline (Day 1) randomization, enrolled subjects were given three screening doses of any anti-VEGF therapy, excluding brolucizumab-dbll, and two monthly loading doses of aflibercept 2 mg prior to Day 1, 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, received these loading doses at Weeks -8 and -4 prior to randomization on Day 1.

Current wording

Over the six-month screening and lead-in period prior to Baseline (Day 1) randomization, enrolled subjects were given three screening doses of any anti-vascular endothelial growth factor, or anti-VEGF, therapy, excluding brolucizumab-dbll, and two monthly loading doses of aflibercept 2 mg prior to Day 1, and monitored to exclude subjects demonstrating early persistent fluid or significant retinal fluid fluctuations. Subjects maintaining a central subfield thickness, or 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, received these loading doses at Weeks -8 and -4 prior to randomization on Day 1.

Previous 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.

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, similar to subjects in the AXPAXLI arm. 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 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 is not part of the non-inferiority analysis at Week 56. 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 40. The third arm (aflibercept 8 mg) of the SOL-R trial is not part of the non-inferiority analysis at Week 40. 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

We are amending the trial protocol to add a new key secondary endpoint to evaluate the superiority of AXPAXLI to aflibercept (8 mg) at Week 96. Subjects in the third arm of the SOL-R trial receive aflibercept (8 mg) every 24 weeks, matching the same dosing cadence as the AXPAXLI arm. This new key secondary endpoint will be evaluated at Week 96 to align as closely as possible with the aflibercept (8 mg) Year 2 approved dosing interval, which was recently expanded to up to every five months after one year of treatment. To further assess differentiation from aflibercept (2 mg), dosed every eight weeks in the SOL-R trial, we also intend to evaluate the prevention of fibrosis and atrophy through secondary endpoints at Week 96 with the goal of expanding a potential AXPAXLI label in the future. We expect that the new key secondary superiority endpoint and secondary fibrosis and atrophy endpoints have the potential to establish AXPAXLI as a best-in-disease agent for wet AMD and to further support our efforts to obtain broad global regulatory approvals and adoption of AXPAXLI if approved.

Current wording

The first new key secondary endpoint will evaluate the superiority of AXPAXLI to aflibercept (8 mg), each dosed every 24 weeks, based on the proportion of subjects receiving any supplemental injection prior to Week 96. This new key secondary endpoint was added to align as closely as possible with the aflibercept (8 mg) Year 2 approved dosing interval, which was recently expanded to up to every five months after one year of treatment. To further assess differentiation from aflibercept (2 mg), dosed every eight weeks in the SOL-R trial, we also intend to evaluate the prevention of fibrosis and atrophy through secondary endpoints at Week 96 with the goal of expanding a potential AXPAXLI label in the future. We expect that this new key secondary superiority endpoint and the secondary fibrosis and atrophy endpoints have the potential to establish AXPAXLI as a best-in-disease agent for wet AMD and to further support our efforts to obtain broad global regulatory approvals and adoption of AXPAXLI if approved. The second key secondary endpoint will assess non-inferiority in mean change in BCVA from baseline at Week 56, which was previously the primary endpoint.

Previous wording

In November 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 subjects and investigators. We have now completed randomization of the SOL-R trial with a total of 640 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 2028.

Current wording

In November 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 subjects and investigators. We have subsequently completed randomization of the SOL-R trial with a total of 640 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 2028.

Previous wording

As discussed above under “Plans for Registration”, we plan to conduct an interim safety analysis of the SOL-R trial in the fourth quarter of 2026 to provide Week 52 safety data on subjects dosed with AXPAXLI in the trial in support of our NDA for AXPAXLI for the treatment of wet AMD. All data other than safety data for the interim analysis population will remain masked following the interim analysis, and SOL-R will incur a 0.0001 alpha penalty in connection with its primary statistical analysis as a result of conducting the interim analysis. The SOL-R primary endpoint of non-inferiority in mean BCVA change from baseline between the AXPAXLI and on-label aflibercept (2 mg)

Current wording

As discussed above under “Plans for Registration”, we plan to conduct an interim safety analysis of the SOL-R trial in the fourth quarter of 2026 to provide Week 52 safety data on subjects dosed with AXPAXLI in the trial in support of our NDA for AXPAXLI for the treatment of wet AMD. All data other than safety data for the interim analysis population will remain masked following the interim analysis, and SOL-R will incur a 0.0001 alpha penalty in connection with its primary endpoint analysis as a result of conducting the interim safety analysis.

Previous 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.

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. To date, the vast majority of eligible subjects in the SOL-1 and SOL-R trials have elected to participate in the SOL-X trial. 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. Under the original protocol, subjects enrolled in the SOL-X trial received AXPAXLI 450 μg every 24 weeks and are evaluated at Week 4, Week 12, and every 12 weeks thereafter. Based on the durability of AXPAXLI observed in the SOL-1 trial we plan to amend the SOL-X trial protocol to change the dosing interval to every 48 weeks, which we believe may more closely reflect potential real-world dosing of AXPAXLI, if approved.

Previous wording

In the HELIOS-3 trial, NPDR subjects receive either AXPAXLI orasham injection at randomization andagain at Week 48. The primary endpoint is an ordinal 2-step change statusin diabetic retinopathy severity scale, or DRSS, from baseline at Week 56. 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.

Current wording

In the HELIOS-3 trial, NPDR subjects receive either AXPAXLI or a sham injection at Day 1 and again at Week 48 as determined by the treatment arm to which they were randomized. The primary endpoint is an ordinal 2-step change status in diabetic retinopathy severity scale, or DRSS, from baseline at Week 56. 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

Our net product revenue was $13.5 million for the three months ended June 30, 2026, reflecting an increase of $0.1 million or 0.7% over the three months ended June 30, 2025. Our net product revenue was $24.3 million for the six months ended June 30, 2026, reflecting an increase of $0.3 million or 1.3% over the six months ended June 30, 2025, as unit growth was offset by increased year-over-year gross to net adjustments including increases in off-invoice discounts, or OIDs, following a price increase implemented in the second quarter of 2025.

Current wording

Our net product revenue was $12.9 million for the three months ended September 30, 2026, reflecting a decrease of $1.6 million or 11.0% as compared to the three months ended September 30, 2025. Our net product revenue was $37.1 million for the nine months ended September 30, 2026, reflecting a decrease of $1.4 million or 3.9% as compared to the nine months ended September 30, 2025, as unit growth was offset by increased year-over-year gross to net adjustments including increases in off-invoice discounts, or OIDs, following a price increase implemented in the second quarter of 2025.

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 Direct Sales. We recorded In-Market Sales of approximately 50,000 units in the three months ended June 30, 2026, an increase of approximately 8,000 units compared to the three months ended March 31, 2026, reflecting seasonal ordering patterns. 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 higher gross to net adjustments based on the increases in OIDs described above.

Current wording

September 30, 2026, a decrease of approximately 1,000 units compared to the three months ended June 30, 2026. 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 and beyond, we expect unit sales volume to grow at an incremental rate as compared to prior quarters in 2026 with a stabilization in our gross-to-net provisions, or GTN Provisions.

Previous wording

We record DEXTENZA product sales net of applicable reserves for variable consideration, including OIDs, estimated chargebacks, rebates, distribution fees, product returns, and other incentives. Collectively, these discounts, allowances and other reserves are generally referred to as gross-to-net provisions, or GTN Provisions.

Current wording

We record DEXTENZA product sales net of applicable reserves for variable consideration, including OIDs, estimated chargebacks, rebates, distribution fees, product returns, and other incentives. Collectively, these discounts, allowances and other reserves are generally referred to as GTN Provisions.

Previous wording

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.

Current wording

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

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 six months ended June 30, 2026 and 2025, our interest-bearing debt included the Barings Credit Facility ($82.5 million outstanding principal).

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 and nine months ended September 30, 2026 and 2025, our interest-bearing debt included the Barings Credit Facility ($82.5 million outstanding principal).

Previous wording

The following table summarizes our results of operations for the six months ended June 30, 2026 and 2025:

Current wording

The following table summarizes our results of operations for the three months ended September 30, 2026 and 2025:

Previous wording

Our product revenue, net, was $13.5 million and $13.4 million for the three months ended June 30, 2026 and 2025, respectively, reflecting an increase of $0.1 million year-over-year. All of our product revenue, net, was attributable to sales of DEXTENZA.

Current wording

Our product revenue, net, was $12.9 million and $14.5 million for the three months ended September 30, 2026 and 2025, respectively, reflecting a decrease of $1.6 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 June 30, 2026 and 2025 were 55.0% and 51.7%, 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.

Current wording

Our total GTN Provisions for the three months ended September 30, 2026 and 2025 were 57.7% and 52.5%, 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

Previous wording

Compared to the three months ended June 30, 2025, the GTN Provisions relative to gross DEXTENZA product sales increased during the three months ended June 30, 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.

Current wording

Compared to the three months ended September 30, 2025, the GTN Provisions relative to gross DEXTENZA product sales increased during the three months ended September 30, 2026, primarily as a result of the changes in the OID. We expect that GTN Provisions relative to gross DEXTENZA product sales will remain relatively stable for the remainder of 2026 and beyond.

Previous wording

We did not recognize any collaboration revenue during the three months ended June 30, 2026. During the three months ended June 30, 2025, we recognized $0.1 million of collaboration revenue related to the performance obligation under our license agreement with AffaMed Therapeutics Limited, or AffaMed, to conduct a Phase 2 clinical trial of OTX-TIC. We do not expect to recognize additional collaboration revenue for the remainder of 2026, as we have fully satisfied this performance obligation.

Current wording

We did not recognize any collaboration revenue during the three months ended September 30, 2026 and 2025.

Previous wording

For the three months ended June 30, 2026, we incurred $29.5 million in direct research and development expenses for our products and product candidates compared to $34.1 million for the three months ended June 30, 2025. The decrease of $4.6 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.

Current wording

For the three months ended September 30, 2026, we incurred $49.4 million in direct research and development expenses for our products and product candidates compared to $35.9 million for the three months ended September 30, 2025. The increase of $13.5 million is related primarily to increased activities for AXPAXLI clinical trials.

Previous wording

We expect that direct research and development expenses for our products and product candidates will increase 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 2028, 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.

Current wording

We expect that direct research and development expenses for our products and product candidates will increase 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 2028, 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, planned NDA preparation activities, and pre-commercial manufacturing scale-up.

Previous wording

The increase is due to an increase in personnel-related costs, including stock-based compensation, of $3.0 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 $0.3 million, including costs related to our corporate branding and launch planning; and an increase in facility-related and other costs of $0.2 million with the associated headcount expansion.

Current wording

The increase is due to an increase in personnel-related costs, including stock-based compensation, of $1.3 million, primarily reflecting the expansion of our pre-commercial team to prepare for a potential AXPAXLI wet AMD launch, and an increase in professional fees of $1.3 million, including costs related to our corporate branding and launch planning, partially offset by a slight decrease in facility-related and other costs.

Previous wording

The increase was due to an increase in personnel-related costs, including stock-based compensation, of $4.1 million, an increase in professional fees of $2.5 million, and an increase in facility-related and other costs of $1.2 million.

Current wording

The increase was due to an increase in personnel-related costs, including stock-based compensation, of $1.1 million, an increase in professional fees of $1.2 million, and an increase in facility-related and other costs of $0.5 million.

Previous wording

Interest Income. Interest income was $5.4 million and $3.5 million for the three months ended June 30, 2026 and 2025, respectively, reflecting an increase of $1.9 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.

Current wording

Interest Income. Interest income was $5.0 million and $3.7 million for the three months ended September 30, 2026 and 2025, respectively, reflecting an increase of $1.3 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

*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 $0.7 million for the three months ended June 30, 2026. We recognized a net loss from the change in fair value of our derivative liability related to the Barings Credit Agreement of $0.6 million for the three months ended June 30, 2025.

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 $0.9 million for the three months ended September 30, 2026. 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.

Previous wording

The net gain for the three months ended June 30, 2026 is comprised of a non-cash gain of $1.2 million from the change in the fair value of the derivative liability, partially offset by an expense of $0.5 million related to DEXTENZA royalty fees under the Barings Credit Agreement that we paid or accrued.

Current wording

The net gain for the three months ended September 30, 2026 is comprised of a non-cash gain of $1.4 million from the change in the fair value of the derivative liability, partially offset by an expense of $0.5 million related to DEXTENZA royalty fees under the Barings Credit Agreement that we paid or accrued.

Previous wording

The net loss for the three months ended June 30, 2025 is comprised of a non-cash loss of $0.2 million from the change in the fair value of the derivative liability and an expense of $0.5 million expense related to royalty fees under the Barings Credit Agreement that we paid or accrued.

Current wording

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.

Previous wording

Our product revenue, net was $24.3 million and $24.0 million for the six months ended June 30, 2026 and 2025, respectively, reflecting an increase of $0.3 million year-over-year. All of our product revenue, net, was attributable to sales of DEXTENZA.

Current wording

Our product revenue, net was $37.1 million and $38.6 million for the nine months ended September 30, 2026 and 2025, respectively, reflecting a decrease of $1.4 million year-over-year. All of our product revenue, net, was attributable to sales of DEXTENZA.

Previous wording

Our total GTN Provisions for the six months ended June 30, 2026 and 2025 were 54.6% and 50.7%, respectively, of gross DEXTENZA product sales. Compared to the six months ended June 30, 2025, the GTN Provisions relative to gross DEXTENZA product sales increased during the six months ended June 30, 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.

Current wording

Our total GTN Provisions for the nine months ended September 30, 2026 and 2025 were 55.7% and 51.4%, respectively, of gross DEXTENZA product sales. Compared to the nine months ended September 30, 2025, the GTN Provisions relative to gross DEXTENZA product sales increased during the nine months ended September 30, 2026, primarily as a result of the changes in the OID. We expect that GTN Provisions relative to gross DEXTENZA product sales will remain relatively stable for the remainder of 2026 and beyond.

Previous wording

We did not recognize any collaboration revenue during the six months ended June 30, 2026. Our collaboration revenue was $0.1 million for the six months ended June 30, 2025. 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. We do not expect to recognize additional collaboration revenue for the remainder of 2026, as we have fully satisfied this performance obligation.

Current wording

We did not recognize any collaboration revenue during the nine months ended September 30, 2026. Our collaboration revenue was $0.1 million for the nine months ended September 30, 2025. 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. We do not expect to recognize additional collaboration revenue for the remainder of 2026, as we have fully satisfied this performance obligation.

Previous wording

Within research and development expenses, expenses for clinical programs increased $13.1 million, unallocated expenses increased $13.3 million, and expenses for preclinical programs were not material.

Current wording

Within research and development expenses, expenses for clinical programs increased $25.9 million, unallocated expenses increased $23.0 million, and expenses for preclinical programs were not material.

Previous wording

For the six months ended June 30, 2026, we incurred $72.7 million in direct research and development expenses for our products and product candidates compared to $59.6 million for the six months ended June 30, 2025. The increase of $13.1 million is related to timing and conduct 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.

Current wording

For the nine months ended September 30, 2026, we incurred $122.1 million in direct research and development expenses for our products and product candidates compared to $96.2 million for the nine months ended September 30, 2025. The increase of $25.9 million is primarily related to increases in activities related to AXPAXLI clinical trials and a $4.9 million cost for 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, offset by costs related to timing and conduct of our ongoing programs and clinical trials for our product candidates.

Previous wording

We expect that direct research and development expenses for our products and product candidates will continue to increase 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 2028, 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.

Current wording

We expect that direct research and development expenses for our products and product candidates will continue to increase 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 2028, 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, planned NDA preparation activities, and pre-commercial manufacturing scale-up.

Previous wording

The following table summarizes our selling and marketing expenses for the six months ended June 30, 2026 and 2025:

Current wording

The following table summarizes our selling and marketing expenses for the nine months ended September 30, 2026 and 2025:

Previous wording

The increase was primarily due to an increase in personnel-related costs, including stock-based compensation, of $5.0 million, and costs related to the expansion of our marketing team for AXPAXLI; an increase in professional fees of $0.4 million, including costs related to our corporate branding and launch planning; and an increase in facility-related and other costs of $0.6 million.

Current wording

The increase was primarily due to an increase in personnel-related costs, including stock-based compensation, of $6.3 million, and costs related to the expansion of our marketing team for AXPAXLI; an increase in professional fees of $1.7 million, including costs related to our corporate branding and launch planning; and an increase in facility-related and other costs of $0.5 million.