Aldeyra Therapeutics Resubmits New Drug Application for Reproxalap to FDA for Dry Eye Disease Treatment

Reuters
06/17
Aldeyra <a href="https://laohu8.com/S/LENZ">Therapeutics</a> Resubmits New Drug Application for Reproxalap to FDA for Dry Eye Disease Treatment

Aldeyra Therapeutics Inc., a biotechnology company focused on developing innovative therapies for immune-mediated and metabolic diseases, has announced the resubmission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for reproxalap, an investigational drug for dry eye disease. This resubmission follows the achievement of the primary endpoint in a Phase 3 clinical trial, addressing previous methodological concerns raised by the FDA in a Complete Response Letter received in April 2025. The trial showed statistically significant results favoring reproxalap, with no notable baseline differences across treatment arms and no safety concerns. The FDA is expected to acknowledge acceptance for review within 30 days and complete the review within 6 months as per the Prescription Drug User Fee Act guidelines.

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: 20250617568242) on June 17, 2025, and is solely responsible for the information contained therein.

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