FDA Extends Review Timeline For Aldeyra's Dry Eye Disease Drug

The U.S. Food and Drug Administration (FDA) on Monday extended the Prescription Drug User Fee Act (PDUFA) target action date (decision date) for Aldeyra Therapeutics, Inc.’s (NASDAQ:ALDX) reproxalap New Drug Application (NDA) for dry eye disease.

The extended PDUFA target action date is March 16, 2026.

NDA Review Background And Prior FDA Actions

Following submission on June 16, 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.

Also Read: FDA Rejects Aldeyra’s Reproxalap For Dry Eye Disease Again, Citing Efficacy Concerns

Last Friday, the FDA met with Aldeyra 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 the vehicle, did not meet the primary endpoint of improvement in dry eye symptoms relative to the vehicle control.

Before submitting the NDA in June, the field trial was discussed with the FDA.

NDA Amendment And Regulatory Review Details

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 on the same day of the meeting and was considered a major amendment to the NDA by the FDA.

Per the FDA’s earlier request during the NDA review, the safety data from the field trial were submitted to the NDA on August 21. The FDA has reviewed the CSR under the IND.

Labeling Discussions And Next Regulatory Milestones

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.

ALDX Stock Action: Aldeyra Therapeutics shares fell 12.1% to close at $3.99 on Monday. The stock slipped another 1.5% in premarket trading Tuesday to $3.93, according to Benzinga Pro data.

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