LEXINGTON, Mass. – Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) has resubmitted its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its investigational drug reproxalap, a topical ocular treatment targeting the signs and symptoms of dry eye disease. The resubmission follows the completion of a new Phase 3 dry eye chamber trial that successfully met its primary endpoint, as agreed upon with the FDA.
The new clinical data included in the filing comes from a randomized, double-masked, vehicle-controlled trial that evaluated reproxalap’s ability to reduce ocular discomfort, an FDA-accepted symptom of dry eye disease. The trial demonstrated statistically significant efficacy with a primary endpoint achievement (P=0.002) and no notable baseline differences across treatment arms—key concerns raised in the FDA’s prior Complete Response Letter (CRL) from April 2025.
“Consistent with a number of clinical trials that suggest the potential of reproxalap to rapidly improve the symptoms of dry eye disease, we believe the clinical trial results included in the resubmission announced today are robust,” said Dr. Todd C. Brady, President and CEO of Aldeyra. “Based on the highly statistically significant achievement of the prespecified primary endpoint and recent discussions with the FDA, we believe that previous concerns have been addressed.”
The April CRL cited potential methodological issues in a previous trial, particularly regarding baseline imbalances across treatment groups, and requested an additional symptom-focused study. Aldeyra’s newly completed trial showed no such imbalances and confirmed the safety profile of reproxalap. The most common adverse event was mild, transient discomfort at the site of eye drop instillation, typically lasting less than one minute.
The NDA resubmission will be subject to standard Prescription Drug User Fee Act (PDUFA) guidelines, including FDA acknowledgment of review acceptance within 30 days and a review period expected to be completed within six months.
If approved, reproxalap could offer a new treatment option for millions of patients affected by dry eye disease, a chronic condition for which therapeutic innovation remains limited.
