OCUL

EX-99.1

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EXHIBIT 99.1

Exhibit 99.1

Ocular Therapeutix™ Reports Third Quarter 2026 Financial Results and Business Highlights

AXPAXLI™

NDA submission for wet AMD on track for 4Q 2026 following upcoming SOL-R interim Week 52 safety analysis

Several FDA interactions, including most recent September 2026 Pre-NDA Meeting, reaffirm alignment on submission package under 505(b)(2) pathway

SOL-1 post-hoc

analyses presented at AAO and Empire Forum show subjects without early persistent retinal fluid and fluid variability had better visual outcomes with fewer rescues

SOL-R prospectively

excludes subjects with early persistent retinal fluid and fluid variability, with preliminary analysis indicating ~20% of otherwise eligible subjects excluded from SOL-R randomization for these reasons

SOL-R primary

endpoint moved to Week 40 (from Week 56) to ensure all subjects complete primary efficacy visit before the interim safety analysis in accordance with the FDA-aligned masking plan, with key secondary endpoints at Weeks 56 and 96

SOL-X enrollment

continues with plans to implement every 48-week dosing in the open-label protocol based on the durability shown in SOL-1

HELIOS-3 Phase

3 Diabetic Retinopathy trial enrollment progressing

Commercial readiness activities accelerated with investments in commercial infrastructure, market access planning, and launch execution capabilities

Ocular appoints Riad Sherif, MD, to Board of Directors, bringing extensive global commercial experience at Alcon, Novartis, Sanofi, and Oculis

Cash balance of $530.6 million as of September 30, 2026, with expected runway into 2028

BEDFORD, MA, November 9, 2026 (GLOBE NEWSWIRE) -- Ocular Therapeutix, Inc. (NASDAQ: OCUL, “Ocular”), an integrated biopharmaceutical company committed to redefining the retina experience, today reported financial results for the third quarter ended September 30, 2026, and provided recent business highlights including upcoming NDA submission plans for AXPAXLI™ (also known as OTX-TKI), its investigational product candidate for the treatment of wet age-related macular degeneration (wet AMD) and diabetic retinal diseases.

“2026 has been a transformational year for Ocular Therapeutix and we are in a strong position as we prepare to submit our NDA for AXPAXLI in wet AMD under the 505(b)(2) regulatory pathway,” said Pravin U. Dugel, MD, Executive Chairman, President and CEO of Ocular Therapeutix. “Frequent injections define today’s wet AMD treatment experience, and we believe AXPAXLI has the transformative potential to drastically reduce the burden on patients and caregivers. Following our positive pre-NDA meeting in September, we remain aligned with the FDA on our planned submission in the fourth quarter. Recent clinical results from our peers underscore the critical importance of molecular potency, sustained durability, and thoughtful clinical trial design – principles that have guided our AXPAXLI development strategy from the outset. SOL-1 post-hoc analyses presented at AAO reinforce AXPAXLI's remarkable sustained anatomical control, with approximately 70% of subjects who were quantitatively dry at Week 8 remaining dry through Week 36 following a single injection, using a strict AI-based fluid analysis that detects even trace fluid. At last week’s Empire Forum in New York City, we presented additional post hoc analyses showing that approximately 28% of AXPAXLI-treated subjects in SOL-1 experienced early persistent retinal fluid. These patients had worse visual outcomes, increased variability in total retinal fluid volume, increased need for supplemental injections, and a 32-week earlier time to first supplemental injection compared to subjects without early persistent fluid in the same period. These findings are particularly encouraging for SOL-R, which was deliberately designed with the goal of randomizing patients with minimal early retinal fluid and fluid variability. Preliminary analyses of SOL-R screening indicate that approximately 20% of otherwise eligible subjects were excluded from randomization due to early persistent retinal fluid or fluid variability. By contrast, this volatile group of patients were not excluded from SOL-1. The combination of axitinib’s differentiated potency, AXPAXLI’s disease control and durability shown in SOL-1, and our disciplined patient selection strategy further strengthens our confidence in the likelihood of SOL-R’s success.”

Dr. Dugel concluded, “With the competitive landscape evolving, AXPAXLI is now the only intravitreal sustained release maintenance agent with positive Phase 3 data in wet AMD. We believe our opportunity to fundamentally transform the treatment paradigm has never been greater. As such, we are rapidly advancing our commercial readiness, including the addition of Dr. Riad Sherif to our Board of Directors, who brings extensive global commercial experience in ophthalmology at Alcon, Novartis, Sanofi, and Oculis. We continue to progress our

EX-99.1

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EXHIBIT 99.1

Exhibit 99.1

Ocular Therapeutix™ Reports Second Quarter 2026 Financial Results and Business Highlights

Ocular’s AXPAXLITM wet AMD NDA submission on track for Q4 2026 following positive Type C Meeting with the U.S. FDA in May 2026

FDA Type C Meeting Minutes Formalize SOL-1 Trial with Confirmatory Evidence as Sufficient to Support Submission of AXPAXLI NDA in wet AMD

AXPAXLI NDA submission to be based on SOL-1 Week 52 efficacy and safety data, interim SOL-R safety data, and confirmatory evidence

Pre-NDA meeting

scheduled with FDA in Q3 2026 with the NDA submission to follow the Section 505(b)(2) pathway which could accelerate the review timeline by up to 60 days

New Post Hoc SOL-1 analysis demonstrates up

to an estimated 72% reduction in treatment burden over 60 weeks with AXPAXLI as compared to a projected on-label aflibercept (2 mg) dosing schedule of every 8 weeks

Commercial readiness accelerating ahead of a potential 2027 launch

Cash balance of $598.6 million as of June 30, 2026, with expected runway into 2028

BEDFORD, MA, August 3, 2026 (GLOBE NEWSWIRE) -- Ocular Therapeutix, Inc. (NASDAQ: OCUL, “Ocular”), an integrated biopharmaceutical company committed to redefining the retina experience, today reported financial results for the second quarter ended June 30, 2026, and provided recent business highlights focused on its NDA submission plan and further clinical development for AXPAXLI (also known as OTX-TKI). The Company will not be hosting a second quarter 2026 conference call following its recent investor day in June. The Company plans to resume quarterly earnings calls for its third quarter 2026 financial results.

“We continue to execute with discipline, precision, and urgency to redefine the retina experience and make AXPAXLI available to patients as early as possible. Our June Investor Day marked a pivotal milestone with the announcement of a clear, FDA-aligned path to submit the AXPAXLI NDA for wet AMD in the fourth quarter of 2026,” said Pravin U. Dugel, MD, Executive Chairman, President and CEO of Ocular Therapeutix. “This approach is designed to support the fastest risk-mitigated path to NDA submission and review. Consistent with the FDA Type C meeting minutes, the AXPAXLI NDA submission will be based on SOL-1 efficacy and safety data, interim safety data from SOL-R and supporting confirmatory evidence, including axitinib’s established profile as a VEGFR inhibitor from more than a decade of clinical use since FDA approval for renal cell carcinoma. By pursuing the 505(b)(2) regulatory pathway, we believe the AXPAXLI NDA submission is strongly positioned to benefit from a review timeline up to 60 days shorter than the typical new molecular entity.”

Peter K. Kaiser, MD, Chief Development Officer of Ocular Therapeutix added, “SOL-1 is the first and only successful superiority trial of a novel agent against an approved anti-VEGF therapy since the class emerged two decades ago. Today, up to 40% of wet AMD patients discontinue therapy within the first year alone, largely attributable to the treatment burden and its impact on patients and caregivers. In a new post-hoc analysis of SOL-1 data applying the SOL-R rescue criteria of >5 ETDRS letter loss and ≥75 µm CSFT increase from baseline, we estimate a treatment burden reduction of up to 72% as compared to a projected on-label dosing regimen of aflibercept (2 mg) over 60 weeks. The robust potential of AXPAXLI to reduce treatment burden in the real-world may improve adherence and long-term outcomes for our patients.”

Estimated Reduction in Treatment Burden Excluding Loading Doses

Mean Number of Expected Injections Per Subject*

AXPAXLI

aflibercept (2 mg)

Injection Burden Reduction

From Week -8 to Week 52

1.95

7.00

72 %

Estimated Reduction in Treatment Burden Including Loading Doses

Mean Number of Expected

Injections Per Subject*

AXPAXLI

aflibercept (2 mg) Injection Burden

Reduction

From Week -8 to Week 52

3.95 9.00 56%

*Methodology outlined below in “Recent Achievements and Upcoming Milestones”

Recent Achievements and Upcoming Milestones:

·New Drug Application (NDA) submission for AXPAXLI in wet AMD planned for Q4 2026, with FDA alignment confirmed in May 2026 Type C meeting minutes. The NDA submission will be based on SOL-1 efficacy and safety data, an interim SOL-R safety analysis of patients who have reached Week 52 to be conducted in the fourth quarter of 2026, and confirmatory evidence. Together with the existing SOL-1 safety database, this interim SOL-R safety analysis will bring the aggregate safety dataset to more than 300 patients with at least one year of AXPAXLI safety data and in-line with FDA requirements. A pre-NDA meeting with the FDA is scheduled for the third quarter of 2026. Ocular intends to submit the NDA under the 505(b)(2) pathway, which could accelerate the review timeline by up to 60 days.

·Post-hoc Analysis of SOL-1 (Phase 3, wet AMD) demonstrates up to an

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