Ocular Therapeutix, Inc. (OCUL) announced that it will present detailed results from the SOL-1 Phase 3 superiority clinical trial of AXPAXLI, its investigational axitinib intravitreal hydrogel therapy for wet age-related macular degeneration (wet AMD), at the 49th Macula Society Annual Meeting on February 27, 2026. The company will also host an investor webcast on March 2, 2026, to review the data and discuss the presentations.
AXPAXLI is being developed for the treatment of wet age-related macular degeneration (wet AMD), a leading cause of vision loss among older adults, and is also under investigation for diabetic retinal diseases, including non-proliferative diabetic retinopathy (NPDR).
Recently, Ocular Therapeutix reported positive topline results from the landmark SOL-1 Phase 3 superiority trial of AXPAXLI in wet AMD, confirming that the study met its primary endpoint and demonstrated statistically significant improvements in vision outcomes compared to Aflibercept.
Ocular intends to submit a New Drug Application (NDA) based on SOL-1 data, subject to planned formal discussions with the U.S. FDA. If approved, AXPAXLI could be the first tyrosine kinase inhibitor (TKI) to be commercialized in wet AMD, and potentially the only therapy with a superiority label and best-in-disease durability.
The SOL-1 trial is part of Ocular's late-stage program evaluating AXPAXLI, which leverages the company's proprietary ELUTYX bioresorbable hydrogel technology. In addition to wet AMD, AXPAXLI is being studied in diabetic retinal disease, including non-proliferative diabetic retinopathy (NPDR).
Upcoming Milestones
• SOL-R Trial: A Phase 3 non-inferiority study in wet AMD, topline data expected in Q1 2027.
• SOL-X Extension: An open-label safety follow-up study planned for Q2 2026, allowing patients from SOL-1 and SOL-R to continue for long-term monitoring.
• HELIOS-3 Trial: Ongoing Phase 3 superiority study assessing AXPAXLI in patients with moderately severe to severe non-proliferative diabetic retinopathy (NPDR) without center-involved diabetic macular edema.
The company ended the year 2025, with total cash and cash equivalents of $737.1 million.
OCUL has traded between $5.78 and $16.44 over the past year. On February 20, 2026, the stock closed at $7.78, up 10.67%.
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