Posted by Michael Wonder on 22 Dec 2022
Aldeyra Therapeutics submits new drug application to the US FDA for ADX‑2191 for the treatment of primary vitreoretinal lymphoma
21 December 2022 - Aldeyra Therapeutics today announced the submission of a new drug application to the US FDA for ADX‑2191 (methotrexate injection, USP), an investigational drug candidate, for the treatment of primary vitreoretinal lymphoma, a rare but potentially fatal cancer with no FDA approved therapy.
The submission is supported by a combination of published literature on the safety and efficacy of methotrexate for the treatment of primary vitreoretinal lymphoma and safety data from the recently completed Phase 3 GUARD Trial of ADX‑2191 for the prevention of proliferative vitreoretinopathy.
