secwatch.observer — SEC 8-K summary
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Issuer:     Aldeyra Therapeutics, Inc. (ALDX)
CIK:        0001341235
Form:       8-K
Filed at:   2025-06-26T23:59:59+00:00
Accession:  0001213900-25-058035
Event type: regulatory
Sentiment:  positive
Materiality: 0.85
Item codes: 7.01, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

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

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1341235/000121390025058035/0001213900-25-058035-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1341235/000121390025058035/ea0247000-8k_aldeyra.htm
  HTML page:      https://secwatch.observer/filing/0001213900-25-058035

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