Aldeyra Therapeutics announced on May 6, 2025, the achievement of the primary endpoint in a Phase 3 randomized, double-masked, vehicle-controlled dry eye chamber trial of 0.25% reproxalap ophthalmic solution. Reproxalap demonstrated statistical superiority to vehicle (P=0.002) for the prespecified primary endpoint of ocular discomfort, a key symptom of dry eye disease. This positive outcome is a crucial development for the company's lead investigational drug.
The company believes that these dry eye chamber trial results, which showed no notable differences in baseline scores across treatment arms, potentially address the U.S. Food and Drug Administration's (FDA) feedback from the Complete Response Letter received in April 2025. The previous CRL had identified concerns with methodological issues, including baseline differences, in a prior dry eye chamber trial. This new data directly aims to resolve those regulatory concerns.
Following these results and pending a Type A meeting with the FDA, Aldeyra anticipates resubmitting the New Drug Application (NDA) for reproxalap by mid-2025, with an expected six-month review period. A recently completed dry eye disease field trial, while numerically supportive, did not reach statistical significance but is expected to be included in the planned NDA resubmission as supportive data. No safety signals or treatment-related discontinuations were observed in the new trials, and reproxalap was well tolerated.
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