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

Core Insights - Ocular Therapeutix is showcasing significant advancements in its clinical programs for AXPAXLI, particularly in wet AMD and diabetic retinopathy, during its Investor Day [1][2][3] - The company is on track to release topline data for the SOL-1 trial in Q1 2026 and for the SOL-R trial in H1 2027, with both trials demonstrating strong patient retention and adherence [1][3][5] Wet AMD Program Highlights - The SOL-1 trial has over 95% retention of randomized subjects and is designed to potentially support the first superiority label over aflibercept (2 mg) for wet AMD [3][4] - The SOL-R trial incorporates a comprehensive patient selection strategy to minimize variability in visual acuity, with topline data expected in H1 2027 [3][5][16] - AXPAXLI is positioned to optimize retina practices globally, allowing for less frequent patient visits and potentially improving treatment outcomes [2][6] Diabetic Retinopathy Program Highlights - Ocular plans to initiate two registrational trials, HELIOS-2 and HELIOS-3, for non-proliferative diabetic retinopathy (NPDR), targeting a broad treatment label [7][8] - HELIOS-2 will compare AXPAXLI to ranibizumab (0.3 mg) with a primary endpoint at Week 52, while HELIOS-3 will evaluate two dosing regimens of AXPAXLI against sham [8][9][24] - The trials will utilize a novel ordinal endpoint for assessing diabetic retinopathy severity, which is expected to enhance the probability of success and reduce trial size [9][24][25] AXPAXLI Overview - AXPAXLI (OTX-TKI) is an investigational bioresorbable hydrogel incorporating axitinib, aimed at treating wet AMD and diabetic retinopathy [10][33] - The product is currently in Phase 3 clinical trials, with a focus on improving long-term patient outcomes and reducing treatment burdens [10][33] Company Background - Ocular Therapeutix is committed to redefining the retina experience and has developed a pipeline that includes DEXTENZA, an FDA-approved corticosteroid for ocular conditions [32][34]