Aldeyra Therapeutics announced that the FDA has accepted for review the resubmitted new drug application (NDA) of reproxalap to treat the signs and symptoms of dry eye disease (DED). The FDA assigned a Prescription Drug User Fee Act (PDUFA) target action date for December 16, 2025.

The resubmission acceptance comes 3 months after Aldeyra received its second complete response letter (CRL) from the FDA stating that potential methodological issues in a previously completed dry eye chamber trial, including a baseline difference across treatment arms, may have affected the interpretation of the results. The CRL stated that an additional symptom trial would be required for resubmission.

“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,” Todd C. Brady, MD, PhD, President and Chief Executive Officer of Aldeyra, said in a company news release. “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.”

In May 2025, Aldeyra announced the achievement of the primary endpoint (P=0.002) in a phase 3 randomized, double‑masked, vehicle‑controlled dry eye chamber trial that assessed the activity of reproxalap in reducing ocular discomfort. For the prespecified primary endpoint of ocular discomfort, reproxalap (n=58) was statistically significantly superior to vehicle (n=58) on ocular discomfort symptom score (0‑100) from 80 to 100 minutes after chamber entry (LS mean difference [95% confidence interval] ‑6.5 [‑10.5, ‑2.5], P=0.002). No safety concerns were identified. Consistent with prior clinical trials, the most common adverse event was mild and transient instillation site discomfort, which most commonly lasted less than one minute.