regulatory
confidence high
sentiment positive
materiality 0.70
Ocular Therapeutix to submit AXPAXLI NDA based on SOL-1 year 1 data after FDA flexibility signal
OCULAR THERAPEUTIX, INC
- FDA signals may allow single pivotal trial for AXPAXLI in wet AMD, changing prior two-trial requirement.
- Ocular Therapeutix now plans to submit NDA based on year 1 data from SOL-1 Phase 3 trial.
- Top-line year 1 data from SOL-1 expected in Q1 2026.
- Company will engage with FDA on regulatory pathway for AXPAXLI.