FDA Accepts Aldeyra's Resubmitted NDA For Reproxalap For Treatment Of Dry Eye Disease

(RTTNews) - Aldeyra Therapeutics, Inc. (ALDX) Thursday said that the U.S. Food and Drug Administration (FDA) has accepted the resubmitted New Drug Application (NDA) for reproxalap for the treatment of dry eye disease.

Prescription Drug User Fee Act (PDUFA) target action date, the date on which a decision from the regulator is expected, is December 16, 2025.

"Based on the FDA's requirement for an additional clinical trial demonstrating the efficacy of reproxalap in treating the symptoms of dry eye disease, and per agreement with the FDA, the NDA resubmission contained a single clinical trial that achieved the primary endpoint of reducing ocular discomfort relative to the vehicle control," stated Todd C. Brady, President and Chief Executive Officer of Aldeyra.