Aldeyra Therapeutics, Inc., a biotechnology company, discovers and develops therapies designed to treat immune-mediated diseases. Its lead product candidate is reproxalap, a reactive aldehyde species (RASP) modulator, which is in Phase III clinical trial for the treatment of dry eye disease and allergic conjunctivitis; and ADX-2191, a dihydrofolate reductase inhibitor for the treatment of primary vitreoretinal lymphoma and retinitis pigmentosa. The company also develops ADX-629, an orally administered RASP modulator that is in Phase 2 clinical trials for the treatment of COVID-19, atopic asthma, psoriasis, and alcohol intoxication. In addition, it develops preclinical RASP platforms, including ADX 248, ADX 246, and other novel RASP modulators for the treatment of various diseases associated with RASP. The company was formerly known as Aldexa Therapeutics, Inc. and changed its name to Aldeyra Therapeutics, Inc. in March 2014. Aldeyra Therapeutics, Inc. was incorporated in 2004 and is based in Lexington, Massachusetts.
Aldeyra Therapeutics Announces Intent to Submit Formal Dispute Resolution Request for Reproxalap to Treat Dry Eye Disease
Aldeyra Therapeutics announced it will submit a Formal Dispute Resolution Request to the FDA appealing the March 16, 2026 Complete Response Letter that denied approval of reproxalap for dry eye disease.
This is the third CRL for reproxalap across three NDA submissions; the most recent stated the totality of evidence does not support the product's effectiveness. Aldeyra expects the FDRR to be reviewed by the Office of New Drugs with a meeting in Q4 2026.
The company reported $45.1M in cash as of June 30, 2026 and updated guidance to extend its operational cash runway into 2029.
The FDRR outcome is uncertain and may depend on whether the deciding official requests additional data or convenes an advisory panel.