FDA issues second Complete Response Letter for Aldeyra's reproxalap NDA; efficacy concerns cited

Aldeyra Therapeutics, Inc.

CRL states 'lack of substantial evidence' and 'failed to demonstrate efficacy' for dry eye disease signs and symptoms.
No safety or manufacturing concerns identified; FDA did not recommend additional trials or confirmatory evidence.
Aldeyra intends to request Type A meeting within 30 days to determine next steps for approval.
Cash and marketable securities of $70M as of Dec 31, 2025 expected to fund operations into 2028.

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