ADX 2191 filed with FDA for primary vitreoretinal lymphoma.- Aldeyra Therapeutics

The NDA submission is supported by a combination of published literature on the safety and efficacy of methotrexate for the treatment of primary vitreoretinal lymphoma and safety data from the recently completed Phase III GUARD Trial of ADX 2191 for the prevention of 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. In the Phase III GUARD Trial, the incidence of punctate keratitis with ADX 2191 administration was observed to be less than that previously reported with intravitreal injection of compounded methotrexate.

ADX 2191 has received FDA Orphan Drug Designation for the treatment of primary vitreoretinal lymphoma. In addition, as part of the NDA submission, Aldeyra requested Priority Review Designation, which reduces the review period during which the FDA aims to take action on an NDA to within 6 months, compared to 10 months under standard review. A Type C meeting with the FDA to discuss the completion of clinical development of ADX 2191 for the prevention of proliferative vitreoretinopathy is planned for the first half of 2023, and results from the Phase II clinical trial of ADX 2191 in retinitis pigmentosa are expected in the first half of 2023.