---
schema_version: "secwatch.filing_event.v1"
accession: "0001213900-25-054949"
form_type: "8-K"
ticker: "ALDX"
cik: "0001341235"
company_name: "Aldeyra Therapeutics, Inc."
filed_at: "2025-06-17T23:59:59+00:00"
generated_at: "2026-05-19T04:25:47.287999+00:00"
event_type: "regulatory"
sentiment: "neutral"
materiality_score: 0.8
calibrated_materiality_score: 0.8
confidence: "high"
source: SEC EDGAR
---

# Aldeyra resubmits reproxalap NDA for dry eye disease after CRL, Phase 3 trial met primary endpoint

## Summary
- Resubmitted NDA to FDA for topical ocular reproxalap to treat signs and symptoms of dry eye disease.
- Earlier CRL in April 2025 cited potential methodological issues; new Phase 3 dry eye chamber trial achieved primary endpoint (P=0.002).
- No notable baseline differences across treatment arms; mild transient instillation site discomfort was most common AE.
- PDUFA goal: FDA acceptance decision within 30 days, review completion within 6 months of submission.

## SEC filing metadata
- accession: 0001213900-25-054949
- form_type: 8-K
- ticker: ALDX
- cik: 0001341235
- company_name: Aldeyra Therapeutics, Inc.
- filed_at: 2025-06-17T23:59:59+00:00
- event_type: regulatory
- sentiment: neutral
- materiality_score: 0.8
- calibrated_materiality_score: 0.8
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1341235/000121390025054949/0001213900-25-054949-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1341235/000121390025054949/ea0245870-8k_aldeyra.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001213900-25-054949
- JSON: https://secwatch.observer/filing/0001213900-25-054949.json
- Plain text: https://secwatch.observer/filing/0001213900-25-054949.txt

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