Ocular Therapeutix announced FDA alignment on its new drug application for AXPAXLI in wet age-related macular degeneration during an investor day event. The company reached agreement with the FDA to include safety data from the Phase 3 SOL-R trial in the NDA submission while excluding its efficacy data, following a Type C meeting. A pre-NDA meeting is expected in the third quarter of 2026, with a complete NDA package submission anticipated in the fourth quarter alongside an interim safety analysis for SOL-R. If approved, AXPAXLI could launch in 2027, with topline SOL-R efficacy data planned for early 2028. The drug is also being studied in diabetic retinopathy in the HELIOS-3 registrational trial.
Ocular Therapeutix IncFDA alignment on NDA submission for AXPAXLI in wet AMD, with potential launch in 2027
Advanced Micro Devices Inc