Aldeyra Therapeutics FDA Extends Reproxalap Target Action Date to March 16, 2026
The company states: "Aldeyra Therapeutics announced that the FDA has extended the Prescription Drug User Fee Act (PDUFA) target action date for the reproxalap New Drug Application 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. On December 12, 2025, 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 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."
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FDA Prolongs Review Period for Aldeyra's Drug for Dry Eye Disease
FDA Action on Aldeyra's NDA: The FDA has extended the target action date for Aldeyra Therapeutics' New Drug Application (NDA) for reproxalap, a treatment for dry eye disease, to March 16, 2026, following a request for additional clinical data.
Clinical Trial Results: The field trial for reproxalap did not meet its primary endpoint of improving dry eye symptoms compared to the vehicle control, despite being supportive of the drug's activity.
Regulatory Review Process: Aldeyra submitted a Clinical Study Report (CSR) as a major amendment to the NDA, and the FDA plans to communicate any proposed labeling requests by February 16, 2026, if no major deficiencies are found.
Stock Market Reaction: Following the FDA's announcement, Aldeyra Therapeutics' stock fell by 12.1% to $3.99, with a further decline of 1.5% in premarket trading.
