Core Insights - Ocular Therapeutix has successfully completed enrollment for the SOL-R trial, the largest retinal TKI trial to date, with a target randomization of at least 555 subjects [1][2][6] - The SOL-1 trial, which is complementary to SOL-R, completed randomization in December 2024 and is on track for top-line readout in Q1 2026 [1][2] - Both trials are designed to support a New Drug Application (NDA) submission for AXPAXLI in wet age-related macular degeneration (wet AMD) [1][3][4] Company Overview - Ocular Therapeutix is a fully-integrated biopharmaceutical company focused on redefining the retina experience [14] - AXPAXLI, the investigational product candidate, is a bioresorbable intravitreal hydrogel incorporating axitinib, aimed at treating wet AMD and other retinal diseases [5][14] - The company is leveraging its proprietary ELUTYX technology in both AXPAXLI and its commercial product DEXTENZA [15] Clinical Trials - The SOL-R trial is a Phase 3 registrational study evaluating the safety and efficacy of AXPAXLI, involving approximately 100 sites across the U.S., Argentina, India, and Australia [6][8] - The primary endpoint of SOL-R is to demonstrate non-inferiority in mean change in best corrected visual acuity (BCVA) compared to aflibercept at Week 56, with a non-inferiority margin of -4.5 letters [8][11] - The SOL-1 trial aims to evaluate the proportion of subjects maintaining visual acuity at Week 36, with a focus on durability up to Week 52 [11][9] Market Context - Wet AMD is a leading cause of blindness, affecting approximately 14.5 million individuals globally and 1.7 million in the U.S. [12][13] - Current treatments face challenges such as the need for frequent injections and high patient discontinuation rates, highlighting the need for more durable therapies [13] - AXPAXLI has the potential to significantly reduce treatment burden and improve long-term vision outcomes for patients with wet AMD [3][4]

2025 RBC Capital Markets Global Healthcare Conference, May 20, 2025 Fireside Chat Date: Tuesday, May 20, 2025 Fireside Chat Time: 2:35PM ET Presenter: Pravin U. Dugel, MD, Executive Chairman, President and CEO Location: New York, NY BEDFORD, Mass., May 14, 2025 (GLOBE NEWSWIRE) -- Ocular Therapeutix, Inc. (NASDAQ: OCUL, "Ocular"), a fully-integrated biopharmaceutical company committed to redefining the retina experience, today announced participation in several upcoming investor conferences in the second ha ...

Company Participation in Investor Conferences - Ocular Therapeutix, Inc. will participate in the 24th Annual Needham Virtual Healthcare Conference on April 7, 2025, at 3:00 PM ET, with Dr. Pravin U. Dugel presenting [1] - The company will also host investor one-on-one meetings at the Piper Sandler Spring Biopharma Symposium on April 17, 2025, in Boston, MA [2] Product Pipeline and Technology - Ocular Therapeutix is focused on redefining the retina experience, with its product candidate AXPAXLI™ (axitinib intravitreal hydrogel) currently in Phase 3 clinical trials for wet age-related macular degeneration (wet AMD) [3] - The company utilizes its proprietary ELUTYX™ bioresorbable hydrogel-based formulation technology in its commercial product DEXTENZA®, which is FDA-approved for treating ocular inflammation and pain following surgery, as well as in PAXTRAVA™ (travoprost intracameral hydrogel), currently in Phase 2 clinical trials for open-angle glaucoma or ocular hypertension [4]