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.
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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.
