Business
Ocular Therapeutix™ Reports Fourth Quarter and Full Year 2025 Financial Results and Business Highlights
SOL-1 Phase 3 superiority trial results remain masked to date SOL-1 data expected to be presented at the 49th Macula Society Annual Meeting Ocular plans to
About this update from Ocular Therapeutix, Inc.
[{"type":"text","content":"SOL-1 Phase 3 superiority trial results remain masked to date SOL-1 data expected to be presented at the 49th Macula Society Annual Meeting Ocular plans to submit NDA for AXPAXLI™ in wet AMD based on SOL-1 52 Week data, pending positive results and planned FDA interactions Completed randomization of 631 subjects in SOL-R Phase 3 non-inferiority trial in December 2025; timing of topline results accelerated and now anticipated in 1Q 2027 HELIOS-3 Phase 3 trial in diabetic retinopathy underway Cash balance of $737.1 million as of December 31, 2025, with expected runway into 2028 BEDFORD, Mass., Feb. 05, 2026 (GLOBE NEWSWIRE) -- Ocular Therapeutix, Inc. (NASDAQ: OCUL, “Ocular”), an integrated biopharmaceutical company committed to redefining the retina experience, today provided recent business highlights and reported financial results for the fourth quarter and year ended December 31, 2025. The business highlights include updated timing for the presentation of topline results of the SOL-1 Phase 3 superiority clinical trial of AXPAXLI™ (also known as OTX-TKI), for the treatment of wet age-related macular degeneration (wet AMD), which are expected to be presented at the 49th Macula Society Annual Meeting, taking place between February 25 – 28, 2026. Ocular will not be hosting a fourth quarter 2025 conference call as it is currently observing a quiet period in connection with the anticipated SOL-1 clinical trial data readout. The Company plans to resume quarterly earnings calls for its first quarter 2026 financial results. Recent Achievements and Upcoming Milestones: SOL-1 (Phase 3, wet AMD) superiority trial on track for topline data in the second half of February 2026. Week 52 results for the SOL-1 trial are expected to be presented at the 49th Macula Society Annual Meeting, taking place between February 25 – 28, 2026. The SOL-1 superiority trial, conducted under a Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug Administration (FDA), has the potential to support the first label with a superiority claim over a single dose of aflibercept (2 mg) for any wet AMD product. All subjects have completed their Week 52 visit and have been re-dosed according to their baseline treatment assignment. The trial continues to maintain an exceptional rate of patient retention and per protocol-defined treatment rescues. To date,...