Ocular Therapeutix announced that its registrational SOL-R trial of Axpaxli (OTX-TKI) for wet age-related macular degeneration has reached its enrollment goal of 555 patients. The company will continue to randomize patients currently in the loading phase but said topline data remain expected in the first half of 2027.

Axpaxli is also being evaluated in the SOL-1 phase 3 superiority trial in wet AMD, which is designed under a special protocol assessment with the US Food and Drug Administration (FDA). Top-line results from SOL-1 are anticipated in the first quarter of 2026. According to the company, more than 95% of randomized participants remain on study, and no safety concerns have been reported by the independent monitoring committee. Patients completing either SOL-1 or SOL-R will be eligible for the SOL-X open-label extension, which will assess long-term outcomes and the effects of delayed initiation of Axpaxli.

Ocular Therapeutix is also preparing to begin the HELIOS phase 3 program for nonproliferative diabetic retinopathy. The study will employ an ordinal diabetic retinopathy severity score endpoint, agreed to with the FDA through a special protocol assessment for HELIOS-2, and will evaluate dosing intervals of 6 and 12 months. RP