FDA accepts for priority review ADX 2191 NDA for the treatment of primary vitreoretinal lymphoma. -Aldeyra Pharma
Aldeyra Therapeutics, Inc. announced that the FDA accepted for Priority Review the New Drug Application (NDA) for ADX 2191 (methotrexate injection, USP), an investigational drug candidate, for the treatment of primary vitreoretinal lymphoma. The FDA assigned a Prescription Drug User Fee Act (PDUFA) date of June 21, 2023. The FDA noted that no potential filing review issues have been identified.
The NDA submission is supported by a combination of more than three decades of published literature on the safety and efficacy of methotrexate, the active ingredient of ADX 2191, for the treatment of primary vitreoretinal lymphoma, in addition to safety data from the recently completed Phase III GUARD Trial of ADX 2191 in patients with proliferative vitreoretinopathy. During the Phase III GUARD Trial, no safety signals were observed, and ADX 2191 was well tolerated; there were no observed treatment-emergent serious adverse events. The most common adverse event associated with ADX 2191 treatment was punctate keratitis, a frequently observed side effect of intravitreal methotrexate, that was most commonly mild in severity.
Learning Zones
The Learning Zones are an educational resource for healthcare professionals that provide medical information on the epidemiology, pathophysiology and burden of disease, as well as diagnostic techniques and treatment regimens.