Aldeyra to challenge FDA rejection of dry eye drug reproxalap

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Go back to Aldeyra to challenge FDA rejection of dry eye drug reproxalap

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

September 29, 2026 7:00 AM EDT

CONCORD, Mass.--(BUSINESS WIRE)-- 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 FDAs Office of New Drugs (OND), is designed to appeal the March 16, 2026 Complete Response Letter that denied approval of a New Drug Application... More