What Ocular Therapeutix (OCUL) Said on Its Q3 Earnings Call

Key Points

• Ocular Therapeutix plans to submit a U.S. application for investigational wet AMD treatment AXPAXLI in Q4 2026, using Phase 3 SOL-1 efficacy results and safety data from SOL-1 and SOL-R. The company expects the safety database to include more than 300 patients with at least one year of follow-up; AXPAXLI is not FDA-approved.
• The company moved SOL-R’s primary endpoint to week 40 from week 56, while retaining longer-term assessments; topline results are expected in Q1 2028. It also plans to extend SOL-X dosing intervals to 48 weeks, citing confidence in AXPAXLI’s durability.
• Ocular reported $530.6 million in cash at the end of Q3 and said funds are expected to last into 2028 under current assumptions, excluding full commercialization costs. If approved, the company intends to position AXPAXLI as a maintenance therapy after initial disease control.

Ocular Therapeutix NASDAQ: OCUL plans to submit a U.S. application in the fourth quarter of 2026 for AXPAXLI, its investigational treatment for wet age-related macular degeneration, executives said on the company’s third-quarter earnings call.

The planned submission follows a September pre-application meeting with the Food and Drug Administration and will draw on results from the Phase 3 SOL-1 trial, along with interim safety data from the separate SOL-R study. The company also outlined changes to two ongoing studies as it prepares for a potential launch.

AXPAXLI has not been approved for marketing, and its safety and efficacy have not been established by the FDA or another regulatory authority, Vice President of Investor Relations Bill Slattery Jr. said.

Application to Rely on SOL-1 and Safety Data

Executive Chairman, President and CEO Dr. Pravin Dugel said Ocular remains aligned with the FDA on its planned application package. It will include SOL-1 efficacy data through week 52, safety data from SOL-1 and an interim SOL-R analysis, and additional confirmatory evidence.

The company expects its safety database at submission to include more than 300 patients with at least one year of follow-up after AXPAXLI treatment. Ocular also plans to provide repeat-dosing safety data during the review process.

Ocular intends to use the FDA’s 505(b)(2) pathway, which Dugel said could shorten the review timeline by up to 60 days compared with the traditional pathway for a new molecular entity.

In SOL-1, AXPAXLI demonstrated superiority in vision maintenance over a single administration of aflibercept 2 mg, according to the company. Dugel said approximately 75% of AXPAXLI-treated patients maintained vision at the week 36 primary endpoint. He also said about two-thirds were free of rescue treatment at 12 months after one injection.

SOL-R Endpoint and Extension Study Changes

Ocular moved the primary efficacy endpoint in SOL-R to week 40 from week 56. Chief Medical Officer Dr. Nadia Waheed said the change was designed to ensure all patients completed their primary assessments before a subset of safety data is unmasked for the planned application, reducing the risk of operational bias.

Waheed said the week 40 endpoint exceeds the 36-week minimum in FDA draft guidance for neovascular AMD. The study’s longer-term secondary endpoints at weeks 56 and 96 remain in place, and topline results are expected in the first quarter of 2028.

Asked whether the FDA had requested the endpoint change, Dugel did not directly answer. He said the company began discussions after a May Type C meeting and that the change was aligned with regulatory agencies. Ocular said SOL-R efficacy results are not required for the planned U.S. application, although positive data could support commercial use and international regulatory submissions.

The company also plans to change the dosing interval in SOL-X, its open-label extension study, to 48 weeks from 24 weeks. Waheed said the decision reflects increased confidence in the treatment’s durability based on analyses of SOL-1. The extension study is intended to evaluate potential annual maintenance dosing and longer-term outcomes.

Post-Hoc Analyses and Commercial Plans

Waheed described a post-hoc SOL-1 analysis using an artificial intelligence-based assessment of retinal fluid. Approximately 71% of AXPAXLI-treated participants met the analysis’s definition of a quantitatively dry retina at week eight; of those patients, approximately 70% remained dry through week 36 after a single AXPAXLI injection.

A separate post-hoc analysis found that about 28% of AXPAXLI-treated SOL-1 participants had early persistent fluid or fluid variability. Those patients had worse visual outcomes and needed supplemental injections earlier and more frequently than patients without early persistent fluid, Waheed said.

SOL-R includes a six-month screening and loading period designed to exclude patients with early persistent fluid or significant variability. Preliminary analysis indicated that approximately 20% of otherwise eligible patients were excluded from randomization for those reasons, she said.

Global Chief Commercial Officer David Robinson said Ocular is preparing to position AXPAXLI, if approved, as a maintenance therapy after initial disease control with other anti-VEGF treatments. He said a potential superiority label could support premium pricing, though labeling discussions with the FDA have not yet taken place.

Cash Runway and Other Developments

Ocular ended the third quarter with $530.6 million in cash and cash equivalents. Dugel said the company expects those funds to last into 2028 under current assumptions, excluding the full anticipated cost of commercializing AXPAXLI.

The company continues to enroll patients in HELIOS-3, a Phase 3 study evaluating once-yearly AXPAXLI in diabetic retinal disease. Dugel said Ocular expects to provide more detail on its diabetic retinal disease strategy in 2027.

Ocular also said Dr. Riad Sherif has joined its board, while Dr. Seung Suh Hong will retire from the board at year-end. Dugel said the change reflects a greater emphasis on commercial expertise as the company prepares for a potential launch.

About Ocular Therapeutix (NASDAQ:OCUL)

Ocular Therapeutix, Inc is a biopharmaceutical company focused on developing and commercializing treatments for eye diseases and conditions. Based in Bedford, Massachusetts, the company uses its proprietary hydrogel-based technology to deliver medicines to the eye over time.

Its marketed product, DEXTENZA, is a corticosteroid insert placed in the tear duct by an eye-care professional to treat inflammation and pain following ophthalmic surgery. Ocular Therapeutix also develops investigational therapies for retinal diseases and other eye conditions, including treatments designed for sustained drug delivery.

The company was founded in 2006 and serves the U.S.

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