Aldeyra Therapeutics announced on July 17, 2025, that the U.S. Food and Drug Administration (FDA) has accepted for review the resubmitted New Drug Application (NDA) for topical ocular reproxalap. This first-in-class investigational drug candidate is being developed for the treatment of the signs and symptoms of dry eye disease. The FDA's acceptance signifies a critical step forward in the regulatory process.
The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of December 16, 2025. This date provides a clear timeline for a potential regulatory decision on reproxalap. The NDA resubmission, per FDA requirements, contained a single clinical trial that successfully achieved its primary endpoint of reducing ocular discomfort relative to the vehicle control.
Aldeyra's President and Chief Executive Officer, Todd C. Brady, M.D., Ph.D., stated that the company looks forward to a productive dialogue with the FDA during the review. Reproxalap remains the only late-stage topical ocular therapy to have demonstrated acute activity in reducing both ocular discomfort and redness in pivotal trials, addressing key aspects of dry eye disease flares.
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