---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-23-283679"
form_type: "8-K"
ticker: "ALDX"
cik: "0001341235"
company_name: "Aldeyra Therapeutics, Inc."
filed_at: "2023-11-28T23:59:59+00:00"
generated_at: "2026-06-07T20:53:44.589808+00:00"
event_type: "regulatory"
sentiment: "negative"
materiality_score: 0.8
calibrated_materiality_score: 0.8
confidence: "high"
source: SEC EDGAR
---

# FDA issues Complete Response Letter for reproxalap NDA in dry eye disease; additional trial required

## Summary
- FDA CRL states NDA did not demonstrate efficacy on ocular symptoms; requires at least one additional adequate and well-controlled study.
- No safety or manufacturing issues identified.
- Aldeyra submitted SPA for chamber crossover trial on Nov 16; expects FDA feedback in Dec 2023.
- Proposed trial cost <$2M, top-line results expected H1 2024; potential NDA resubmission in H1 2024.
- Cash runway extended to late 2025, with $143M cash as of Sep 30, 2023.

## SEC filing metadata
- accession: 0001193125-23-283679
- form_type: 8-K
- ticker: ALDX
- cik: 0001341235
- company_name: Aldeyra Therapeutics, Inc.
- filed_at: 2023-11-28T23:59:59+00:00
- event_type: regulatory
- sentiment: negative
- materiality_score: 0.8
- calibrated_materiality_score: 0.8
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1341235/000119312523283679/0001193125-23-283679-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1341235/000119312523283679/d723036d8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-23-283679
- JSON: https://secwatch.observer/filing/0001193125-23-283679.json
- Plain text: https://secwatch.observer/filing/0001193125-23-283679.txt

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