The US Food and Drug Administration (FDA) has granted Priority Review for Aldeyra’s New Drug Application (NDA) for ADX-2191, an investigational drug candidate for the treatment of primary vitreoretinal lymphoma (PVRL) and proliferative vitreoretinopathy.
ADX-2191 is a preservative-free, non-compounded intravitreal formulation of methotrexate for the potential prevention or treatment of specific rare retinal diseases. “The FDA’s decision underscores the significant need for an FDA-approved treatment of primary vitreoretinal lymphoma, a rare but potentially fatal cancer,” said Dr Todd Brady, Aldeyra’s president and CEO. “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.”
Alongside three decades of published literature on the safety and efficacy of methotrexate for primary vitreoretinal lymphoma treatment, Aldeyra said its NDA application was supported by safety data from its recently completed phase 3 Guard trial of ADX-2191 in patients with proliferative vitreoretinopathy. Guard trial researchers said no safety signals were observed and ADX-2191 was well tolerated. The most common adverse event associated with treatment was punctate keratitis, which was most commonly mild in severity.
Aldeyra’s GA treatment progresses
In separate news Aldeyra Therapeutics also announced it had advanced two investigational new drug candidates to clinical testing, including ADX-‑248 for the treatment of geographic atrophy (GA).
