Aldeyra Therapeutics announced that the FDA has extended the Prescription Drug User Fee Act (PDUFA) target action date for the new drug application (NDA) for reproxalap, its investigational treatment for dry eye disease. The new PDUFA target action date is March 16, 2026.

The reproxalap NDA was submitted to the FDA on June 16, 2025, and subsequently accepted for review as a “complete class 2 response” on July 16, 2025. At that time, the FDA assigned an original PDUFA action date of December 16, 2025.

According to Aldeyra, the FDA met with the company on December 12, 2025, during which the agency requested submission of the Clinical Study Report (CSR) for a dry eye disease field trial of reproxalap. Topline results from that trial were announced on May 5, 2025. While the study supported the activity of reproxalap relative to vehicle, it did not meet its primary endpoint of improvement in dry eye symptoms compared with the vehicle control. Aldeyra noted that the field trial and its results had been discussed with the FDA prior to NDA submission.

The CSR, which had previously been submitted to the investigational new drug (IND) file for reproxalap, was submitted to the NDA on the same day as the December 12 meeting. The FDA classified the submission as a major amendment, triggering the extension of the PDUFA review period. Safety data from the field trial had already been submitted to the NDA on August 21, 2025, at the FDA’s earlier request. The agency has reviewed the CSR under the IND.

Aldeyra stated that, aside from the CSR submission, the FDA made no additional requests and did not identify other specific issues with the NDA during the December 12 meeting. In early December, the FDA also shared a draft of the proposed product label with Aldeyra, and the company has since submitted its response. The FDA informed Aldeyra that, if no major deficiencies are identified during the extended review, it plans to communicate proposed labeling requests and any anticipated postmarketing requirements, if necessary, by February 16, 2026.