The Food and Drug Administration (FDA) has accepted for Priority Review the New Drug Application (NDA) for ADX-2191 (methotrexate injection) for the treatment of primary vitreoretinal lymphoma, a rare, aggressive retinal cancer.
ADX-2191 is a preservative-free, intravitreal formulation of methotrexate designed to be vitreous-compatible. The application is supported by safety data from the phase 3 GUARD trial (ClinicalTrials.gov Identifier: NCT04136366), which compared treatment with repeated intravitreal injections of ADX-2191 to standard of care in patients with proliferative vitreoretinopathy.
Findings showed that ADX-2191 was well tolerated; no safety signals or treatment-emergent serious adverse events were observed in the trial. The most common adverse event reported was punctate keratitis, which was mild in severity.
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A Prescription Drug User Fee Act (PDUFA) target date of June 21, 2023 has been set for the application.
“The FDA’s decision to grant Priority Review with a PDUFA date 4 months from NDA acceptance underscores the significant need for an FDA-approved treatment of primary vitreoretinal lymphoma, a rare but potentially fatal cancer,” stated Todd C. Brady, MD, PhD, Aldeyra’s President and CEO. “We are working closely with the FDA during the review process to bring ADX‑2191 to patients as quickly as possible, and plan to launch ADX-2191 in the United States in the second half of this year, pending approval by the FDA.”
Reference
FDA accepts for Priority Review ADX-2191 New Drug Application for the treatment of primary vitreoretinal lymphoma. News release. Aldeyra Therapeutics, Inc. Accessed March 2, 2023. https://www.businesswire.com/news/home/20230301005873/en/FDA-Accepts-for-Priority-Review-ADX-2191-New-Drug-Application-for-the-Treatment-of-Primary-Vitreoretinal-Lymphoma.
This article originally appeared on MPR
