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Ocular Therapeutix™ Announces Plans to Accelerate NDA Submission Timeline for AXPAXLI™ in Wet AMD
Ocular intends to submit AXPAXLI New Drug Application (NDA) for wet AMD shortly after year one data from SOL-1, if positive SOL-1 topline data remain on track
About this update from Ocular Therapeutix, Inc.
[{"type":"text","content":"Ocular intends to submit AXPAXLI New Drug Application (NDA) for wet AMD shortly after year one data from SOL-1, if positive SOL-1 topline data remain on track for 1Q 2026 Ocular plans to leverage the 505(b)(2) regulatory pathway for new drug approvals which has the potential to shorten the review timeline for AXPAXLI If approved, AXPAXLI could be the first TKI to be commercialized in wet AMD, with a potential superiority label and best-in-class durability BEDFORD, Mass., Dec. 08, 2025 (GLOBE NEWSWIRE) -- Ocular Therapeutix, Inc. (NASDAQ: OCUL, “Ocular”), an integrated biopharmaceutical company committed to redefining the retina experience, announced that following recent public statements from U.S. Food and Drug Administration (FDA) leadership and other recent interactions with the FDA’s Division of Ophthalmology, the Company now intends to submit a New Drug Application (NDA) for AXPAXLI™ (also known as OTX-TKI) for the treatment of wet age-related macular degeneration (wet AMD) following year one data, if positive, from its ongoing SOL-1 Phase 3 clinical trial for which data are on track for the first quarter of 2026. “At Ocular Therapeutix, we have always been courageous, opportunistic, and bold in our efforts to redefine retina. Based on recent developments, we now intend to submit our NDA for AXPAXLI in wet AMD shortly after SOL-1 year one data, assuming positive results. SOL-1 is the only ongoing Phase 3 retina trial currently being conducted under a Special Protocol Assessment (SPA) agreement. It is also the only current wet AMD trial exploring superiority compared to a single injection of aflibercept (2 mg) and the only wet AMD registrational trial that we are aware of that is being run completely in alignment with the FDA’s draft guidance and feedback. This triad of factors helps us make a compelling case for a truly differentiated NDA for AXPAXLI in the treatment of wet AMD,” said Pravin U. Dugel, MD, Executive Chairman, President and Chief Executive Officer of Ocular Therapeutix. “Recent FDA leadership comments on the potential for a single registrational trial for new product candidates stressed the importance that these studies be well powered, and well controlled. Being a superiority trial, SOL-1 is substantially powered compared to non-inferiority trials. Moreover, SOL-1 is well controlled, as the active and contro...