ADX-2191 FDA Approval Status
Last updated by Judith Stewart, BPharm on June 23, 2023.
FDA Approved: No
Brand name: ADX-2191
Generic name: methotrexate
Company: Aldeyra Therapeutics, Inc.
Treatment for: Primary Vitreoretinal Lymphoma
ADX-2191 (methotrexate) is an intravitreal formulation of the folate analog metabolic inhibitor methotrexate in development for the treatment of primary vitreoretinal lymphoma.
- Primary vitreoretinal lymphoma is a rare, aggressive, and potentially fatal retinal cancer.
- The current standard of care for primary vitreoretinal lymphoma is compounded intravitreal methotrexate, which carries risks of infection and increased injection volume, potentially leading to ocular hypertension and corneal inflammation.
- ADX-2191 is a sterile, non-compounded intravitreal formulation of methotrexate that is preservative-free, vitreous-compatible, and optimized for excipient composition, viscosity, density, tonicity, pH, concentration, and volume of administration.
- On June 21, 2023, Aldeyra announced receipt of a Complete Response Letter from the U.S. FDA for the 505(b)(2) New Drug Application (NDA) of ADX-2191 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.
Development timeline for ADX-2191
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
