Aldeyra Resubmits NDA for Reproxalap in Dry Eye Disease Treatment

Aldeyra Therapeutics has officially resubmitted its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for topical ocular reproxalap, targeting both the signs and symptoms of dry eye disease (DED).

New Data Aligned with FDA Guidance

According to Aldeyra, the only new clinical data included in the NDA resubmission were derived from a recently completed dry eye chamber trial, which successfully met its prespecified primary endpoint as agreed upon with the FDA.

“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 CEO of Aldeyra. “In conjunction with recent FDA discussions, we believe that previous concerns raised by the FDA have been addressed.”

Addressing FDA's Previous Concerns

The resubmission follows a Complete Response Letter (CRL) received in April 2025, which cited potential methodological issues in a previously completed dry eye chamber trial. Specifically, the FDA had noted baseline differences across treatment arms, potentially impacting result interpretation. The CRL requested an additional symptom trial to support a future NDA resubmission.

Positive Phase 3 Results Support Resubmission

In May 2025, Aldeyra announced successful achievement of the primary endpoint in a phase 3 randomized, double-masked, vehicle-controlled dry eye chamber trial evaluating reproxalap’s ability to reduce ocular discomfort.

Key findings include:

       • Statistically significant improvement in ocular discomfort scores with reproxalap (n=58) versus vehicle (n=58)

       • P=0.002 for the prespecified endpoint measured 80–100 minutes after chamber entry

       • LS mean difference [95% CI]: 6.5 [10.5, 2.5]

       • No safety concerns identified

       • Most common adverse event: mild, transient instillation site discomfort, typically lasting less than one minute

Next Steps Under PDUFA Guidelines

Per Prescription Drug User Fee Act (PDUFA) timelines, the FDA is expected to acknowledge acceptance for review within 30 days of submission and complete its review within 6 months.