LEXINGTON, Mass.– ldeyra Therapeutics (Nasdaq: ALDX) announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for the company’s resubmitted New Drug Application (NDA) for reproxalap, a treatment for the signs and symptoms of dry eye disease. The FDA concluded that the application failed to demonstrate efficacy in “adequate and well controlled studies” and recommended that at least one additional trial be conducted to support approval.
While the agency did not raise any safety or manufacturing concerns, it questioned the reliability of the submitted data, citing methodological issues and inconsistencies in baseline scores across treatment groups.
The decision marks the second CRL for reproxalap. The first, issued in November 2023, also called for additional clinical evidence, specifically a new symptom trial. Since then, Aldeyra has launched three new studies—a dry eye chamber trial, another chamber trial using a different model, and a six-week field trial—to address the FDA’s concerns.
Top-line data from the ongoing field and second chamber trials are expected in the second quarter of 2025. Should the results prove positive, Aldeyra plans to resubmit the NDA by mid-year. The company expects a six-month review period for the potential resubmission.
A Type A meeting with the FDA is anticipated in the coming weeks to discuss the latest CRL and the path forward.
“Pending positive results from the ongoing clinical trials and discussions with the FDA, we look forward to a potential NDA resubmission mid-year 2025,” said Dr. Todd C. Brady, President and CEO of Aldeyra. He emphasized reproxalap’s promise, noting it remains the only late-stage topical ocular therapy for chronic use that may offer rapid improvement in both redness and discomfort associated with dry eye disease.
As of the end of 2024, Aldeyra reported $101 million in cash, cash equivalents, and marketable securities. With most trial-related expenses incurred last year, the company expects approximately $6 million in clinical trial costs for 2025.
