Business
Ocular Therapeutix™ Reports Third Quarter 2025 Financial Results and Business Highlights
Recent Investor Day highlighted how AXPAXLI™ is positioned to redefine retina based on potential superiority label, market expansion, and immediate
About this update from Ocular Therapeutix, Inc.
[{"type":"text","content":"Recent Investor Day highlighted how AXPAXLI™ is positioned to redefine retina based on potential superiority label, market expansion, and immediate adoptability Announced today that SOL-R achieved target randomization of 555 subjects Exceptional execution and retention in AXPAXLI wet AMD registrational program continue with topline data on track for SOL-1 in 1Q 2026 and SOL-R in 1H 2027 Registrational HELIOS program for AXPAXLI in NPDR expected to begin imminently using a novel primary endpoint Cash balance of $344.8 million as of September 30, 2025, together with net proceeds of ~$445 million from October 2025 equity offering, with expected runway into 2028 BEDFORD, Mass., Nov. 04, 2025 (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, 2025 and provided recent business highlights. Separately, Ocular announced today that its SOL-R registrational trial of AXPAXLI™ (also known as OTX-TKI) in wet age-related macular degeneration (wet AMD) has achieved its randomization target of 555 subjects. Ocular will continue to allow randomization of subjects currently in the loading phase of the trial to maintain its commitment to both patients and investigators, with topline data remaining on track for the first half of 2027. “At Ocular Therapeutix, we are courageous, bold, opportunistic, and driven by a refusal to accept the status quo. We think differently about what is possible by designing creative, de-risked clinical programs that are tightly aligned with the FDA, while advancing patient care,\" said Pravin U. Dugel, MD, Executive Chairman, President and Chief Executive Officer of Ocular Therapeutix. “At our September Investor Day, we presented our HELIOS program for AXPAXLI in diabetic retinopathy which embodies this philosophy: we’ve designed a novel ordinal DRSS endpoint that reflects real-world treatment goals, potentially increases the probability of success, and is agreed to by the FDA through our Special Protocol Assessment (SPA) agreement for HELIOS-2. We also shared that the true market opportunity for anti-VEGFs may extend far beyond today’s approximately $15 billion annual market. The opportunity for expansion could be driven by the millions of w...