On April 3, 2025, Aldeyra issued a press release, in which it announced, “receipt of a Complete Response Letter from the U.S. Food and Drug Administration (FDA) for the resubmission of the New Drug Application (NDA) of reproxalap, an investigational drug candidate, for the treatment of dry eye disease.” The press release stated that “the 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.” The press release further stated that “[t]he letter identified concerns with the data from the trial submitted to the NDA that may have affected interpretation of the results.”
On this news, Aldeyra’s stock price fell $3.90 per share, or 73.31% to close at $1.42 per share on April 3, 2025.
