FDA issues complete response letter for Aldeyra’s reproxalap dry eye NDA

Reuters03-17

FDA issues complete response letter for Aldeyra’s reproxalap dry eye NDA

Aldeyra said the FDA issued a Complete Response Letter for the reproxalap New Drug Application for dry eye disease, citing a lack of substantial evidence from adequate and well-controlled studies to support efficacy. The FDA also said inconsistency of study results raised concerns about the reliability and meaningfulness of positive findings, and that the totality of evidence from completed clinical trials did not support effectiveness. Aldeyra reported cash, cash equivalents, and marketable securities of USD 70 million as of Dec. 31, 2025, and said it expects this to support operations into 2028.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Aldeyra Therapeutics Inc. published the original content used to generate this news brief via Business Wire (Ref. ID: 20260317167510) on March 17, 2026, and is solely responsible for the information contained therein.

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