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.
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