other material
confidence high
sentiment positive
materiality 0.85
Aldeyra achieves primary endpoint in Phase 3 dry eye trial of reproxalap; NDA resubmission planned 2024
Aldeyra Therapeutics, Inc.
- Primary endpoint of ocular discomfort met (p=0.004) vs vehicle in 132-patient Phase 3 dry eye chamber trial.
- NDA resubmission for reproxalap anticipated in 2024; FDA review period expected ~6 months.
- Reproxalap studied in over 2,500 patients; no safety signals; mild transient instillation site discomfort most common AE.
- Option agreement with AbbVie includes $100M upfront if exercised, plus up to $300M milestones and profit/loss share.