---
schema_version: "secwatch.filing_event.v1"
accession: "0001213900-25-058035"
form_type: "8-K"
ticker: "ALDX"
cik: "0001341235"
company_name: "Aldeyra Therapeutics, Inc."
filed_at: "2025-06-26T23:59:59+00:00"
generated_at: "2026-05-18T17:40:03.905823+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

# Aldeyra receives FDA Special Protocol Assessment for ADX-2191 in primary vitreoretinal lymphoma

## Summary
- SPA agreement provides FDA alignment on clinical trial design for ADX-2191 (methotrexate injection) to treat PVRL, a rare and fatal cancer with no approved therapy.
- Trial will randomize up to 20 patients 1:1 to a single intravitreal injection vs. eight injections; primary endpoint is cancer cell clearance at 30 days.
- Trial expected to start H2 2025 and conclude in 2026; positive SPA may support NDA resubmission with one adequate and well-controlled study plus literature.
- Prior NDA for ADX-2191 received a Complete Response Letter in June 2023 due to insufficient literature-based efficacy evidence.
- ADX-2191 is a novel, vitreous-compatible methotrexate formulation designed for intraocular injection potentially reducing injection volume vs. compounded methotrexate.

## SEC filing metadata
- accession: 0001213900-25-058035
- form_type: 8-K
- ticker: ALDX
- cik: 0001341235
- company_name: Aldeyra Therapeutics, Inc.
- filed_at: 2025-06-26T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.85
- calibrated_materiality_score: 0.85
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1341235/000121390025058035/0001213900-25-058035-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1341235/000121390025058035/ea0247000-8k_aldeyra.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001213900-25-058035
- JSON: https://secwatch.observer/filing/0001213900-25-058035.json
- Plain text: https://secwatch.observer/filing/0001213900-25-058035.txt

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