---
schema_version: "secwatch.filing_event.v1"
accession: "0001157523-23-001018"
form_type: "8-K"
ticker: "ALDX"
cik: "0001341235"
company_name: "Aldeyra Therapeutics, Inc."
filed_at: "2023-06-21T23:59:59+00:00"
generated_at: "2026-06-13T19:50:15.894900+00:00"
event_type: "regulatory"
sentiment: "negative"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

# FDA issues Complete Response Letter for Aldeyra's ADX-2191 NDA for PVRL

## Summary
- FDA cited lack of substantial evidence due to no adequate well-controlled studies in literature-based NDA.
- No safety or manufacturing issues identified in the Complete Response Letter.
- Aldeyra plans Expanded Access Program discussions with FDA due to methotrexate shortage and no approved PVRL therapy.
- ADX-2191 also under development for proliferative vitreoretinopathy and retinitis pigmentosa.
- Top-line Phase 2 results in retinitis pigmentosa expected to be announced June 2023.

## SEC filing metadata
- accession: 0001157523-23-001018
- form_type: 8-K
- ticker: ALDX
- cik: 0001341235
- company_name: Aldeyra Therapeutics, Inc.
- filed_at: 2023-06-21T23:59:59+00:00
- event_type: regulatory
- sentiment: negative
- materiality_score: 0.85
- calibrated_materiality_score: 0.85
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1341235/000115752323001018/0001157523-23-001018-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1341235/000115752323001018/a53427165.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001157523-23-001018
- JSON: https://secwatch.observer/filing/0001157523-23-001018.json
- Plain text: https://secwatch.observer/filing/0001157523-23-001018.txt

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