Aldeyra says FDA noted substantive review issues related to NDA for reproxalap

In a regulatory filing, earlier this morning, the company stated: “On October 16, 2023, Aldeyra Therapeutics announced that it received minutes from a late-cycle review meeting with the U.S. Food and Drug Administration relating to the new drug application for reproxalap for the treatment of the signs and symptoms of dry eye disease. The Minutes identified substantive review issues in connection with the NDA for reproxalap. The FDA stated that “(i)t does not appear that you have data to support the clinical relevance of the ocular signs to support your dry eye indication.” In subsequent communications between Aldeyra and the FDA, Aldeyra has submitted responses to the FDA that Aldeyra believes to be sufficient to mitigate the identified issues, but the FDA has not directly opined on the sufficiency of the information submitted, has no legal obligation to review the information submitted by Aldeyra, and has indicated that Aldeyra needs to conduct an additional clinical trial to satisfy efficacy requirements. As such, based on the time remaining in the NDA review cycle, the FDA may not be in the position to approve the NDA for reproxalap on or about the Prescription Drug User Fee Act target action date of November 23, 2023 or afterwards, and it may issue a Complete Response Letter and require that Aldeyra conduct additional clinical trials and submit the results of those clinical trials before the application will be reconsidered.”