---
schema_version: "secwatch.filing_event.v1"
accession: "0001157523-22-001777"
form_type: "8-K"
ticker: "ALDX"
cik: "0001341235"
company_name: "Aldeyra Therapeutics, Inc."
filed_at: "2022-12-21T23:59:59+00:00"
generated_at: "2026-06-21T00:43:52.725586+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# Aldeyra submits NDA to FDA for ADX-2191 for primary vitreoretinal lymphoma

## Summary
- 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.

## SEC filing metadata
- accession: 0001157523-22-001777
- form_type: 8-K
- ticker: ALDX
- cik: 0001341235
- company_name: Aldeyra Therapeutics, Inc.
- filed_at: 2022-12-21T23:59:59+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1341235/000115752322001777/0001157523-22-001777-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1341235/000115752322001777/a53110252.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001157523-22-001777
- JSON: https://secwatch.observer/filing/0001157523-22-001777.json
- Plain text: https://secwatch.observer/filing/0001157523-22-001777.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.