Shares of Aldeyra Therapeutics Inc. (ALDX) plummeted nearly 75% in pre-market trading on Tuesday, after the U.S. Food and Drug Administration issued a complete response letter stating insufficient and inconsistent clinical data for the company’s dry eye treatment.
Responding to the company’s application for reproxalap, the FDA cited “a lack of substantial evidence consisting of adequate and well-controlled investigations … that the drug product will have the effect it purports or is represented to have under the conditions of use prescribed, recommended, or suggested in its proposed labelling.”
The letter also read “the application has failed to demonstrate efficacy in adequate and well controlled studies in the treatment of signs and symptoms of dry eye disease.”
Aldeyra said that it does not plan to conduct additional trials and will instead request a Type A meeting with the FDA to determine the steps needed for approval.
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