21 June 2023 - Based on US FDA determination of lack of adequate and well controlled investigations in the scientific literature, complete response letter received for new drug application of ADX-2191 (methotrexate) for the treatment of primary vitreoretinal lymphoma.
Aldeyra today announced receipt of a complete response letter from the US FDA for the new drug application of ADX-2191 (methotrexate), an investigational drug candidate, for the treatment of primary vitreoretinal lymphoma.