FDA Accepts NDA of ADX-2191 for Priority Review

The US Food and Drug Administration (FDA) has accepted for priority review a New Drug Application (NDA) of ADX-2191 for the treatment of primary vitreoretinal lymphoma.

ADX-2191 is a sterile, noncompounded intravitreal formulation of methotrexate for the potential prevention or treatment of specific rare retinal diseases, including primary vitreoretinal lymphoma. The drug could potentially be the first FDA-approved therapy available for this group of patients.

The NDA submission is based on more than three decades of published literature on the safety and efficacy of the drug’s active ingredient, methotrexate, as well as safety data from the recently completed phase III GUARD trial. The trial showed no safety signals and ADX-2191 was well tolerated, with the most common side effect being punctate keratitis.

The FDA assigned a Prescription Drug User Fee Act date of June 21, 2023, and noted that no potential filing review issues have been identified. Pending approval by the FDA, ADX-2191 is planned to be launched in the second half of 2023.

Source: Aldeyra Therapeutics, March 2023