SOL-1 is now expected to be enrolled and fully randomized by year-end 2024
Topline clinical data from SOL-1 are now expected in Q4 2025
BEDFORD, Mass., Oct. 15, 2024 (GLOBE NEWSWIRE) — Ocular Therapeutix, Inc. (NASDAQ: OCUL, “Ocular”, the “Company”), a biopharmaceutical company committed to improving vision in the real world through the development and commercialization of innovative therapies for retinal diseases and other eye conditions, today announced accelerated timelines for the SOL-1 Phase 3 registrational clinical trial of AXPAXLI in wet age-related macular degeneration (wet AMD). The Company now expects the SOL-1 study to be fully enrolled with all patients randomized by the end of 2024. This is meaningfully ahead of prior guidance to complete enrollment by the end of the first quarter of 2025. With this update, topline data from the SOL-1 trial are now expected during the fourth quarter of 2025.
SOL-1 is a superiority study being conducted under a Special Protocol Agreement (SPA) with the U.S. Food and Drug Administration (FDA). Once a subject is enrolled in the study, they receive two loading doses of aflibercept (2 mg), one at Week -8 and another at Week -4. Subjects who achieve pre-defined visual acuity measures are then randomized (1:1) on Day 1 to receive either a single AXPAXLI implant (450 µg) or a single aflibercept (2 mg) injection. The Company plans to randomize approximately 300 subjects in the trial. The primary endpoint is the proportion of subjects who maintain visual acuity, defined as
