Shares of Aldeyra Therapeutics fell over 65% in trading on March 17, 2026, after the company disclosed that it received a Complete Response Letter from the U.S. Food and Drug Administration for reproxalap for dry eye disease. Aldeyra stated that the application “has failed to demonstrate efficacy in adequate and well controlled studies in the treatment of signs and symptoms of dry eye disease” and that “the totality of evidence from the completed clinical trials does not support the effectiveness of the product.” Aldeyra previously disclosed on April 3, 2025 that the FDA stated the reproxalap NDA “failed to demonstrate efficacy in adequate and well controlled studies in treating ocular symptoms associated with dry eyes” and that “at least one additional adequate and well controlled study to demonstrate a positive effect on the treatment of ocular symptoms of dry eye” should be conducted. Block & Leviton is investigating.
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