Aldeyra has submitted a new drug application to the FDA for ADX2191 for the treatment of primary vitreoretinal lymphoma, according to a company press release.
The submission is supported by positive safety data from the phase 3 GUARD Trial that investigated ADX2191 (methotrexate injection, USP) for the prevention of proliferative vitreoretinopathy as well as previously published literature supporting the safety and efficacy of the drug in primary vitreoretinal lymphoma treatment.
According to the release, there were no observed treatment-emergent serious adverse events associated with ADX2191,