---
schema_version: "secwatch.filing_event.v1"
accession: "0001213900-25-064869"
form_type: "8-K"
ticker: "ALDX"
cik: "0001341235"
company_name: "Aldeyra Therapeutics, Inc."
filed_at: "2025-07-17T23:59:59+00:00"
generated_at: "2026-05-18T05:55:53.310298+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# FDA accepts Aldeyra's reproxalap NDA resubmission for dry eye disease; PDUFA Dec 16, 2025

## Summary
- FDA accepted for review the resubmitted NDA for topical ocular reproxalap, a first-in-class candidate for dry eye disease.
- PDUFA target action date set for December 16, 2025.
- Resubmission includes a single clinical trial that met primary endpoint of reducing ocular discomfort vs vehicle control.
- Reproxalap is the only dry eye investigational therapy to show acute activity reducing ocular discomfort and redness in pivotal trials simulating disease flares.

## SEC filing metadata
- accession: 0001213900-25-064869
- form_type: 8-K
- ticker: ALDX
- cik: 0001341235
- company_name: Aldeyra Therapeutics, Inc.
- filed_at: 2025-07-17T23:59:59+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/1341235/000121390025064869/0001213900-25-064869-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1341235/000121390025064869/ea0249257-8k_aldeyra.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001213900-25-064869
- JSON: https://secwatch.observer/filing/0001213900-25-064869.json
- Plain text: https://secwatch.observer/filing/0001213900-25-064869.txt

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