regulatory
confidence high
sentiment positive
materiality 0.75
Aldeyra resubmits reproxalap NDA for dry eye disease after positive Phase 3 trial
Aldeyra Therapeutics, Inc.
- Resubmission includes positive results from FDA-requested symptom trial.
- Phase 3 dry eye chamber trial met primary endpoint (ocular discomfort, P=0.004).
- If approved, reproxalap would be first chronic dry eye therapy with acute symptom and redness data.
- FDA review expected within 6 months of acceptance; acknowledgment in 30 days.
- Reproxalap showed acute activity in reducing dry eye symptoms and ocular redness in trials.