AXPAXLI — FDA meeting
Q3 2026
A pre-NDA meeting with the FDA is scheduled for the third quarter of 2026.Source filing
OCUL biotech catalysts & pipeline
OCULAR THERAPEUTIX INC · Data as of 2026-09-08
Upcoming catalysts
AXPAXLI™ — Topline data
H2 2026
SOL-1 (Phase 3, wet AMD) superiority trial on track for topline data in the second half of February 2026.Source filing
AXPAXLI — Interim data
Q4 2026
The NDA submission will be based on SOL-1 efficacy and safety data, an interim SOL-R safety analysis of patients who have reached Week 52 to be conducted in the fourth quarter of 2026, and confirmatory evidence.Source filing
AXPAXLI — NDA/BLA submission
Q4 2026
New Drug Application (NDA) submission for AXPAXLI in wet AMD planned for Q4 2026, with FDA alignment confirmed in May 2026 Type C meeting minutes.Source filing
AXPAXLI — Topline data
Q1 2028
Following these changes, topline SOL-R results are now expected in the first quarter of 2028.Source filing