secwatch.observer — SEC 8-K summary
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Issuer:     Aldeyra Therapeutics, Inc. (ALDX)
CIK:        0001341235
Form:       8-K
Filed at:   2022-12-21T23:59:59+00:00
Accession:  0001157523-22-001777
Event type: other_material
Sentiment:  positive
Materiality: 0.75
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Aldeyra submits NDA to FDA for ADX-2191 for primary vitreoretinal lymphoma
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- NDA submitted for ADX-2191 (methotrexate) for primary vitreoretinal lymphoma, a rare cancer with no FDA-approved therapy.
- Supported by published literature and Phase 3 GUARD trial safety data; no serious adverse events observed; punctate keratitis most common AE.
- ADX-2191 has FDA Orphan Drug Designation; Priority Review requested for 6-month review target.
- Type C meeting for ADX-2191 in PVR planned H1 2023; Phase 2 results in retinitis pigmentosa expected H1 2023.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1341235/000115752322001777/0001157523-22-001777-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1341235/000115752322001777/a53110252.htm
  HTML page:      https://secwatch.observer/filing/0001157523-22-001777

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer