Primary vitreoretinal lymphoma treatment receives orphan drug designation
The FDA has granted orphan drug designation to ADX-2191 for the treatment of primary vitreoretinal lymphoma, according to a press release from Aldeyra Therapeutics.
ADX-2191 (methotrexate for intravitreal injection) works by inhibiting dihydrofolate reductase, “an enzyme involved in cellular replication and activation,” the release said.
“The FDA’s orphan drug designation fosters an important clinical development and commercialization pathway for ADX-2191, which represents the first methotrexate preparation specifically formulated for intraocular injection,” Todd C. Brady, MD, PhD, president and CEO of Aldeyra, said in the release.
Currently, there are no approved treatments for primary vitreoretinal lymphoma. The FDA previously fast-tracked ADX-2191 for the prevention of proliferative vitreoretinopathy.