In July 2025, the U.S. FDA accepted Aldeyra Therapeutics’ resubmitted New Drug Application (NDA) for Reproxalap, an investigational treatment for dry eye disease, assigning a Prescription Drug User Fee Act (PDUFA) target date of December 16, 2025. The NDA resubmission followed a successful randomized, vehicle-controlled chamber trial that addressed prior agency concerns about efficacy. The trial enrolled approximately 116 patients and demonstrated a statistically significant reduction in ocular discomfort symptoms under dry eye chamber conditions (P=0.002), with a favorable safety profile. This chamber-based design, considered a regulatory benchmark for dry eye efficacy, validated the rapid onset and symptom relief potential of Reproxalap. The FDA had previously issued Complete Response Letters due to lack of sufficient efficacy data. By specifically designing a trial to meet regulatory expectations for acute symptom control, Aldeyra has now aligned its development pathway with clinical and regulatory standards. A positive decision in December would mark the approval of a new class of reactive aldehyde species (RASP) modulators for DED.

Citation:
https://ir.aldeyra.com/news-releases/news-release-details/aldeyra-therapeutics-resubmits-reproxalap-new-drug-application-0

Implications:
The FDA’s NDA acceptance and strong chamber trial results position Reproxalap for potential market entry in late 2025. If approved, it would represent the first RASP modulator, offering differentiated mechanism and rapid symptom relief for DED patients.