Aldeyra Therapeutics announced that the FDA extended the PDUFA target action date for the reproxalap NDA for dry eye disease to March 16, 2026.
The NDA review process included the submission of the Clinical Study Report for the field trial of reproxalap.
The field trial did not meet the primary endpoint of improvement in dry eye symptoms relative to the vehicle control.
PDUFA Extension
FDA extended the PDUFA target action date to March 16, 2026.
Clinical Study Report
Submission of the CSR was requested during the NDA review process.
Field Trial Results
The field trial did not show improvement in dry eye symptoms compared to the control.
Prospective Labeling
Aldeyra received a draft of the prospective label from the FDA.
Conference Call
A conference call will be held on December 16, 2025, to discuss the PDUFA extension.
- The extension of the PDUFA target action date gives Aldeyra more time to address any deficiencies in the NDA review.
- The field trial results not meeting the primary endpoint could impact the potential approval of reproxalap for dry eye disease.
Aldeyra Therapeutics faces a critical period as they work towards addressing the issues raised during the NDA review process for reproxalap.