Ocular Therapeutix targets Q4 2026 NDA filing for AXPAXLI in wet AMD after FDA alignment

Ocular Therapeutix said it has aligned with the U.S. Food and Drug Administration on a filing strategy to submit a new drug application for AXPAXLI in wet age-related macular degeneration in the fourth quarter of 2026. The company plans to base the submission on Phase 3 SOL-1 efficacy and safety results, supported by interim safety data from the ongoing SOL-R study. Ocular said SOL-R efficacy data will not be included in the NDA package and the study will instead be modified to support long-term differentiation.