Aldeyra Therapeutics Announces Intent to Submit Formal Dispute Resolution Request for Reproxalap to Treat Dry Eye Disease

Aldeyra Therapeutics Announces Intent to Submit Formal Dispute Resolution Request for Reproxalap to Treat Dry Eye Disease

Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra), a biotechnology company devoted to discovering and developing innovative therapies designed to treat immune-mediated diseases, today announced intent to submit to the U.S. Food and Drug Administration (FDA) a Formal Dispute Resolution Request (FDRR) for reproxalap, an investigational drug candidate, for the treatment of dry eye disease. The FDRR, which is expected to be reviewed by the FDA’s Office of New Drugs (OND), is designed to appeal the March 16, 2026 Complete Response Letter that denied approval of a New Drug Application (NDA) for reproxalap for the treatment of dry eye disease. Submission of the FDRR and a meeting with the OND are expected in the fourth quarter of 2026.