FDA Priority Review for ADX 2191 NDA to treat 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 FDA’s decision to grant Priority Review with a PDUFA date four months from NDA acceptance underscores the significant need for an FDA-approved treatment of primary vitreoretinal lymphoma, a rare but potentially fatal cancer,” stated Todd C. Brady, M.D., Ph.D., Aldeyra’s President and Chief Executive Officer. “We are working closely with the FDA during the review process to bring ADX 2191 to patients as quickly as possible, and plan to launch ADX 2191 in the United States in the second half of this year, pending approval by the FDA.”

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.