LEXINGTON, Mass. — Aldeyra Therapeutics announced that the U.S. Food and Drug Administration (FDA) has accepted for review the company’s resubmitted New Drug Application (NDA) for reproxalap, an investigational topical ocular therapy for the treatment of dry eye disease. The agency has set a Prescription Drug User Fee Act (PDUFA) target action date of December 16, 2025.
Reproxalap is a first-in-class small-molecule modulator of reactive aldehyde species (RASP), which are known to be elevated in both ocular and systemic inflammatory diseases. The resubmission follows the FDA’s prior request for additional clinical data. According to Aldeyra, the new NDA includes a single clinical trial that met its primary endpoint, demonstrating a statistically significant reduction in ocular discomfort compared to vehicle control.
“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,” said Dr. Todd C. Brady, President and Chief Executive Officer of Aldeyra Therapeutics. “We look forward to a productive dialog with the FDA during the NDA review of reproxalap, which, to our knowledge, remains the only dry eye disease investigational therapy to have demonstrated acute activity in reducing ocular discomfort and redness in pivotal trials simulating the disease flares that are likely the most bothersome aspects of dry eye disease.”
Reproxalap is also in development for allergic conjunctivitis and has been studied in more than 2,900 patients. Across clinical trials, the drug has shown no major safety concerns, with the most common adverse event being mild and transient irritation at the application site. If approved, reproxalap could represent a novel therapeutic option for millions of people affected by dry eye disease.
