Aldeyra: FDA may not approve reproxalap NDA by Nov 23 PDUFA; additional trial needed

Aldeyra Therapeutics, Inc.

FDA late-cycle review states reproxalap lacks data to support clinical relevance of ocular signs for dry eye.
FDA indicated Aldeyra needs to conduct an additional clinical trial to satisfy efficacy requirements.
Based on review timeline, FDA may issue Complete Response Letter and not approve by Nov 23, 2023 PDUFA date.
Aldeyra submitted responses to mitigate issues, but FDA has not opined on sufficiency and has no obligation to review.
Reproxalap NDA accepted in Feb 2023; approval now uncertain, requiring more resources and time.

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