FDA issues Complete Response Letter for reproxalap NDA in dry eye disease; additional trial required

Aldeyra Therapeutics, Inc.

FDA CRL states NDA did not demonstrate efficacy on ocular symptoms; requires at least one additional adequate and well-controlled study.
No safety or manufacturing issues identified.
Aldeyra submitted SPA for chamber crossover trial on Nov 16; expects FDA feedback in Dec 2023.
Proposed trial cost <$2M, top-line results expected H1 2024; potential NDA resubmission in H1 2024.
Cash runway extended to late 2025, with $143M cash as of Sep 30, 2023.

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