Aldeyra Therapeutics encounters a significant setback, with its stock value plummeting nearly 70%. The FDA indicates a potential Complete Response Letter (CRL) for reproxalap, a dry eye treatment, despite a scheduled Prescription Drug User Fee Act (PDUFA) date of November 23, 2023.
Aldeyra Therapeutics’ path toward FDA acceptance of reproxalap, for the treatment of dry eye disease, may have hit a large speed bump.
Early, Monday October 16, 2023, stocks for Aldeyra Therapeutics plummeted nearly 70%,1 after the company received minutes from a late-cycle review meeting (the “Minutes”) with the US FDA indicating the organization may not approve the NDA.
The Minutes identified “substantive review issues in connection with the NDA for reproxalap.” With the FDA stating, “[i]t does not appear that you have data to support the clinical relevance of the ocular signs to support your dry eye indication.”2
According to a document from the United States Securities and Exchange Commission (SEC), “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.”2
It is later stated in the document that “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 (“PDUFA”) 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.”2
The FDA had previously accepted the NDA for reproxalap in the treatment of DED back in February 2023, and if a CRL were issued, would come months after a CRL was previously issued to Outlook Therapeutics’ ONS-5010 for geographic atrophy.