‘Lack of Substantial Evidence’ Leads to FDA Rejection of Aldeyra Dry Eye Disease Drug

Frank Vinluan / medcitynews - Aldeyra said the FDA did not ask for another clinical trial for reproxalap in dry eye disease, but the drug’s mixed record in clinical testing warrants exploration about the reasons for failure, which could identify the appropriate patients for the eye dr…

AI Summary: The FDA has rejected Aldeyra’s reproxalap application, citing a lack of substantial evidence—marking the company’s third setback. Regulators did not demand a fresh, large trial but flagged inconsistent results, prompting investor angst and a slide in the stock. The decision underscores the gap between hopeful early data and regulatory standards.