Aldeyra Therapeutics announced in a press release that the US Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) target action date for the reproxalap new drug application (NDA) for the treatment of dry eye disease. The extended PDUFA target action date is March 16, 2026.

Following submission on June 16, 2025, the NDA was accepted for review as a “complete class 2 response” by the FDA on July 16, 2025, with a target PDUFA action date of December 16, 2025.

According to the company, the FDA met with Aldeyra on December 12, 2025, to request submission to the NDA of the clinical study report (CSR) for the dry eye disease field trial of reproxalap, for which top-line results were announced on May 5, 2025. The field trial, which was supportive of the activity of reproxalap relative to vehicle, did not meet the primary endpoint of improvement in dry eye symptoms relative to the vehicle control. Prior to submitting the NDA in June, the field trial was discussed with the FDA, the company says in the press release. 

According to Aldeyra, at the December 12 meeting, the FDA made no other requests and did not identify any other specific issues with the NDA review. The CSR, which had been previously submitted to the investigational new drug (IND) file for reproxalap, was submitted to the NDA the same day of the meeting and was considered a major amendment to the NDA by the FDA, the company notes. Per the FDA’s earlier request during the NDA review, the safety data from the field trial was submitted to the NDA on August 21, 2025. The CSR has been reviewed by the FDA under the IND, the company says.

According to the company, in early December, the FDA shared with Aldeyra a draft of the prospective label, and Aldeyra has submitted a response. The FDA notified Aldeyra that if no major deficiencies are identified during the extended review, the FDA plans to communicate proposed labeling requests and, if necessary, any anticipated postmarketing requirements by February 16, 2026, the company says in the press release.