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Aldeyra Therapeutics said, on March 17, 2026, that the FDA issued a Complete Response Letter for reproxalap, rejecting the company’s New Drug Application in dry eye disease.
According to the company, the agency said the application failed to provide substantial evidence of efficacy from adequate and well-controlled investigations, and that inconsistent trial results raised concerns about the reliability and meaning of positive findings. The FDA also said the overall clinical evidence did not support effectiveness. No safety or manufacturing deficiencies were identified.
Aldeyra Therapeutics had been engaged in labeling discussions prior to the decision, with draft labeling provided by the FDA in December 2025 and March 2026. The agency did not recommend additional clinical trials or request further confirmatory evidence, instead recommending that Aldeyra investigate the reasons for differing trial results and identify patient populations in which reproxalap may be effective.
As of December 31, 2025, Aldeyra reported $70 million in cash, cash equivalents, and marketable securities, which it said should fund operations into 2028.
Sources: Aldeyra
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