---
schema_version: "secwatch.filing_event.v1"
accession: "0001157523-23-000181"
form_type: "8-K"
ticker: "ALDX"
cik: "0001341235"
company_name: "Aldeyra Therapeutics, Inc."
filed_at: "2023-02-07T23:59:59+00:00"
generated_at: "2026-06-19T22:42:01.740768+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.9
calibrated_materiality_score: 0.9
confidence: "high"
source: SEC EDGAR
---

# FDA accepts Aldeyra's NDA for reproxalap for dry eye disease; PDUFA Nov 23, 2023

## Summary
- FDA accepted NDA for reproxalap, a first-in-class RASP modulator, for signs and symptoms of dry eye disease.
- PDUFA target action date set for November 23, 2023.
- FDA noted no filing review issues identified and no advisory committee meeting currently planned.
- NDA supported by five adequate and well-controlled trials; reproxalap studied in over 2,000 patients with no major safety concerns.
- Aldeyra believes reproxalap could address need for rapid, durable therapy for dry eye patients dissatisfied with current options.

## SEC filing metadata
- accession: 0001157523-23-000181
- form_type: 8-K
- ticker: ALDX
- cik: 0001341235
- company_name: Aldeyra Therapeutics, Inc.
- filed_at: 2023-02-07T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.9
- calibrated_materiality_score: 0.9
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1341235/000115752323000181/0001157523-23-000181-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1341235/000115752323000181/a53304873.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001157523-23-000181
- JSON: https://secwatch.observer/filing/0001157523-23-000181.json
- Plain text: https://secwatch.observer/filing/0001157523-23-000181.txt

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