The FDA has rejected Aldeyra Therapeutics’ application for reproxalap, an investigational treatment for dry eye disease, citing a lack of substantial evidence that the drug is effective.
In a Complete Response Letter, the agency said inconsistent study results raised concerns about the reliability of the drug’s clinical findings, according to a March 17 company statement. While no safety or manufacturing issues were identified, the FDA concluded the totality of evidence did not support approval.
The FDA recommended further exploration into why certain trials failed and whether specific patient populations may benefit but did not request new studies or additional confirmatory data. Aldeyra said it does not plan to conduct more clinical trials and will request a Type A meeting to clarify next steps.
Label drafts were exchanged with the FDA in December 2025 and March 2026, but Aldeyra said negotiations were not completed.
As of Dec. 31, 2025, the company reported $70 million in cash, cash equivalents and marketable securities and said it expects the funds will support operations into 2028.
At the Becker's 11th Annual IT + Revenue Cycle Conference: The Future of AI & Digital Health, taking place September 14–17 in Chicago, healthcare executives and digital leaders from across the country will come together to explore how AI, interoperability, cybersecurity, and revenue cycle innovation are transforming care delivery, strengthening financial performance, and driving the next era of digital health. Apply for complimentary registration now.
