FDA issues Complete Response Letter for Aldeyra's reproxalap dry eye NDA; additional study required

Aldeyra Therapeutics, Inc.

FDA CRL states reproxalap 'failed to demonstrate efficacy' in adequate studies; no safety or manufacturing issues.
Type A meeting expected within ~30 days; top-line data from ongoing chamber and field trials due Q2 2025.
Aldeyra plans NDA resubmission mid-2025 pending positive results and FDA discussions; review period expected 6 months.
Cash, equivalents, and marketable securities $101M as of Dec 31, 2024; 2025 trial costs ~$6M.

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