Aldeyra Therapeutics announced the resubmission of a new drug application (NDA) to the US Food and Drug Administration (FDA) for topical ocular reproxalap, an investigational new drug candidate, for the treatment of signs and symptoms of dry eye disease. Per FDA agreement, the only new clinical data included in the resubmitted NDA were from the recently completed dry eye chamber trial, which achieved the primary endpoint, the company said in a press release.

“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,” stated Todd C. Brady, MD, PhD, president and chief executive officer of Aldeyra, in the press release. “Based on the lack of notable baseline differences across treatment arms and the highly statistically significant achievement of the prespecified primary endpoint in favor of reproxalap over vehicle, in conjunction with recent FDA discussions, we believe that previous concerns raised by the FDA have been addressed.”

In April 2025, Aldeyra received a Complete Response Letter from the FDA that stated 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 letter stated that an additional symptom trial would be required for resubmission. 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, an FDA‑accepted symptom of dry eye disease. According to the company, no notable differences in baseline scores across treatment arms were observed in the clinical trial, and 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 1 minute.

The Prescription Drug User Fee Act target guidelines for NDA resubmissions include acknowledgment of acceptance for review within 30 days of submission, and completion of submission review within 6 months.