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Ocular Therapeutix™ Investor Day to Highlight Exceptional AXPAXLI™ Progress Across SOL Program and Detail Registrational Trial Plans to Pursue a Diabetic Retinopathy Label with a Novel Primary Endpoint

SOL-1 superiority trial continues to demonstrate outstanding patient retention and protocol adherence, with no new or unexpected safety signals observed to

articleOcular Therapeutix, Inc.September 30, 20255/company/ocular-therapeutix-inc/news/ocular-therapeutixtm-investor-day-highlight-exceptional-axpaxlitm-progress-across-sol
Ocular Therapeutix™ Investor Day to Highlight Exceptional AXPAXLI™ Progress Across SOL Program and Detail Registrational Trial Plans to Pursue a Diabetic Retinopathy Label with a Novel Primary Endpoint

About this update from Ocular Therapeutix, Inc.

[{"type":"text","content":"SOL-1 superiority trial continues to demonstrate outstanding patient retention and protocol adherence, with no new or unexpected safety signals observed to date; topline data on track for 1Q 2026 Event to detail how robust SOL-R patient selection strategy, trial design, and potential SOL-1 success could drive confidence in SOL-R outcomes; topline data on track for 1H 2027 Will showcase planned HELIOS-2 and HELIOS-3 registrational trials to evaluate AXPAXLI in non-proliferative diabetic retinopathy (NPDR) using novel primary endpoint, aligned with FDA in HELIOS-2 Special Protocol Assessment (SPA) agreement To outline SOL-X open label extension program and AXPAXLI’s potential to improve long-term outcomes and expand the retinal vascular disease market The live event will begin at 2:00 PM ET in New York City with virtual access available BEDFORD, Mass., Sept. 30, 2025 (GLOBE NEWSWIRE) -- Ocular Therapeutix, Inc. (NASDAQ: OCUL, “Ocular”), an integrated biopharmaceutical company committed to redefining the retina experience, will host an Investor Day today where it will highlight outstanding progress in the SOL wet AMD registrational program, announce plans for a registrational program in non-proliferative diabetic retinopathy (NPDR), and share further details on how AXPAXLI™ (also known as OTX-TKI) is being positioned to redefine retina treatment. \"I continue to be incredibly confident and enthusiastic about the future of Ocular Therapeutix,\" said Pravin U. Dugel, MD, Executive Chairman, President and Chief Executive Officer of Ocular Therapeutix. \"At our Investor Day, we will highlight how Ocular is uniquely positioned for success, anchored by AXPAXLI’s potential to have the first superiority label compared to a single dose of aflibercept (2 mg) in wet AMD, targeting a large market opportunity with significant potential for expansion, and seamless adoptability into clinical practice. A superiority label may allow physicians to avoid step therapy, enabling them to choose the optimal drug for their patients. We believe AXPAXLI is well-positioned to optimize retina practices worldwide, allowing physicians to see more patients, less often.” Dr. Dugel continued, “We are especially thrilled to unveil our plans for diabetic retinopathy (DR) with our HELIOS-2 and HELIOS-3 registrational trials. We have designed these trials to include a...

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