Aldeyra Therapeutics Says FDA Accepts Resubmitted NDA For Reproxalap To Treat Dry Eye Disease

(RTTNews) - Aldeyra Therapeutics, Inc. (ALDX) announced Thursday that the U.S. Food and Drug Administration (FDA) has accepted for review the resubmitted New Drug Application (NDA) for topical ocular reproxalap, a first-in-class investigational new drug candidate, for the treatment of the signs and symptoms of dry eye disease.

The FDA assigned a Prescription Drug User Fee Act (PDUFA) target action date of December 16, 2025.

Reproxalap is an investigational new drug candidate in development for the treatment of dry eye disease and allergic conjunctivitis, two of the largest markets in ophthalmology.