---
schema_version: "secwatch.filing_event.v1"
accession: "0001157523-22-001698"
form_type: "8-K"
ticker: "ALDX"
cik: "0001341235"
company_name: "Aldeyra Therapeutics, Inc."
filed_at: "2022-12-01T23:59:59+00:00"
generated_at: "2026-06-21T10:44:53.727625+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# Aldeyra announces positive FDA pre-NDA meeting for ADX-2191; NDA submission expected by end of 2022

## Summary
- Pre-NDA meeting with FDA concluded positively; NDA for ADX-2191 in primary vitreoretinal lymphoma planned as soon as end of 2022.
- Company intends to request Priority Review, which would shorten FDA review to 6 months.
- ADX-2191 has Orphan Drug Designation; Phase 3 GUARD Trial showed no serious adverse events and was well tolerated.
- Most common adverse event was punctate keratitis, less frequent than previously reported with compounded methotrexate.
- Type C meeting for proliferative vitreoretinopathy and Phase 2 retinitis pigmentosa results expected in first half of 2023.

## SEC filing metadata
- accession: 0001157523-22-001698
- form_type: 8-K
- ticker: ALDX
- cik: 0001341235
- company_name: Aldeyra Therapeutics, Inc.
- filed_at: 2022-12-01T23:59:59+00:00
- event_type: regulatory
- 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/1341235/000115752322001698/0001157523-22-001698-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1341235/000115752322001698/a52993162.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001157523-22-001698
- JSON: https://secwatch.observer/filing/0001157523-22-001698.json
- Plain text: https://secwatch.observer/filing/0001157523-22-001698.txt

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