Fresh off a meeting with the FDA, Aldeyra Therapeutics has announced plans to submit a new drug application (NDA) to the FDA for ADX-2191 for the treatment of primary vitreoretinal lymphoma (PVL) by, potentially, the end of 2022.
Tell me more about ADX-2191
ADX-2191 is a sterile, preservative-free, non-compounded methotrexate formulation that inhibits cell replication in rare retinal diseases.
It was granted orphan drug designation (ODD) by the FDA for the treatment of PVL and retinitis pigmentosa (PR), and the prevention of proliferative vitreoretinopathy (PVR).
What did clinical trials show?
The phase 3 GUARD trial found ADX-2191 to be well tolerated, with no treatment-emergent adverse events (AEs) observed. A mild form of punctate keratitis—a common side effect of intravitreal methotrexate—was the most common AE, but was observed less frequently than in previous studies of intravitreal injections with methotrexate. (via)
What’s next?
Aldeyra intends to request a priority review designation for ADX-2191, which will shorten the FDA review period.
Anything else?
An FDA Type C meeting, essentially a “catch-all” meeting for anything not covered under Type A or B meetings, is planned for the first half of 2023 to discuss the clinical development completion of ADX-2191 for PVR. The company expects results from the phase 2 trial of ADX-2191 for RP before the second half of 2023. (via)