other material
confidence high
sentiment positive
materiality 0.75
Aldeyra submits NDA to FDA for ADX-2191 for primary vitreoretinal lymphoma
Aldeyra Therapeutics, Inc.
- NDA submitted for ADX-2191 (methotrexate) for primary vitreoretinal lymphoma, a rare cancer with no FDA-approved therapy.
- Supported by published literature and Phase 3 GUARD trial safety data; no serious adverse events observed; punctate keratitis most common AE.
- ADX-2191 has FDA Orphan Drug Designation; Priority Review requested for 6-month review target.
- Type C meeting for ADX-2191 in PVR planned H1 2023; Phase 2 results in retinitis pigmentosa expected H1 2023.