Aldeyra Therapeutics Gets CRL From FDA For NDA Of ADX-2191 To Treat Primary Vitreoretinal Lymphoma

(RTTNews) - Biotechnology company Aldeyra Therapeutics, Inc. (ALDX) announced Wednesday the receipt of a Complete Response Letter from the U.S. Food and Drug Administration (FDA) for the 505(b)(2) New Drug Application (NDA) of ADX-2191 (methotrexate for injection, USP), an investigational drug candidate, for the treatment of primary vitreoretinal lymphoma (PVRL).

Although no safety or manufacturing issues with ADX-2191 were identified, the FDA stated that there was a "lack of substantial evidence of effectiveness" due to "a lack of adequate and well-controlled investigations" in the literature-based NDA submission.

Based on prior discussions with the FDA, Aldeyra did not conduct any clinical trials of ADX-2191 in PVRL.

PVRL is a rare, high-grade, aggressive cancer, with a median survival of less than five years. Methotrexate, the compounded intravitreal injection of which is the standard of care for the treatment of PVRL, is currently in shortage, per the FDA Drug Shortages database.

Aldeyra plans to discuss ADX-2191 for the treatment of PVRL with the FDA, including the potential to make ADX-2191 accessible to PVRL patients under an Expanded Access Program protocol.