---
schema_version: "secwatch.filing_event.v1"
accession: "0000950170-25-109932"
form_type: "8-K"
ticker: "ALDX"
cik: "0001341235"
company_name: "Aldeyra Therapeutics, Inc."
filed_at: "2025-08-19T23:59:59+00:00"
generated_at: "2026-05-17T11:22:55.746260+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.55
calibrated_materiality_score: 0.55
confidence: "high"
source: SEC EDGAR
---

# Aldeyra receives FDA Fast Track Designation for ADX-2191 in retinitis pigmentosa

## Summary
- FDA granted Fast Track Designation for ADX-2191 (methotrexate intravitreal injection) for retinitis pigmentosa.
- No approved therapy exists for most forms of retinitis pigmentosa, which affects over 1 million people worldwide.
- Fast Track complements prior Orphan Drug Designation; may allow rolling review or priority/accelerated approval.
- Phase 2/3 trial of ADX-2191 in retinitis pigmentosa expected to start in 2025.
- Phase 2 results (2023) showed improvements from baseline in retinal sensitivity.

## SEC filing metadata
- accession: 0000950170-25-109932
- form_type: 8-K
- ticker: ALDX
- cik: 0001341235
- company_name: Aldeyra Therapeutics, Inc.
- filed_at: 2025-08-19T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.55
- calibrated_materiality_score: 0.55
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1341235/000095017025109932/0000950170-25-109932-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1341235/000095017025109932/aldx-20250819.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0000950170-25-109932
- JSON: https://secwatch.observer/filing/0000950170-25-109932.json
- Plain text: https://secwatch.observer/filing/0000950170-25-109932.txt

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