FDA accepts Aldeyra's NDA for ADX-2191 with Priority Review; PDUFA June 21, 2023

Aldeyra Therapeutics, Inc.

FDA accepted NDA for ADX-2191 (methotrexate injection) for primary vitreoretinal lymphoma with Priority Review.
PDUFA date set for June 21, 2023; FDA noted no potential filing review issues identified.
Planned U.S. launch in second half of 2023, pending FDA approval.
NDA supported by over 30 years of published literature and safety data from Phase 3 GUARD Trial.
ADX-2191 has potential to be first FDA-approved drug for primary vitreoretinal lymphoma.

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