ADX-2191 named orphan medicinal product in Europe
ADX-2191 was designated as an orphan medicinal product by the European Commission for the treatment of retinal detachment, according to a press release from Aldeyra Therapeutics.
Treatments that qualify for this designation are intended to treat a life-threatening or chronically debilitating condition that affects five or fewer people in 10,000 throughout the European Union.
The investigational therapy, an intravitreal formulation of methotrexate, which is in clinical development in the United States for the prevention of proliferative vitreoretinopathy, previously received orphan drug status and fast track designation from the FDA.
Patient enrollment in the two-part, multicenter, randomized, controlled, adaptive phase 3 GUARD clinical trial began in December 2019 to evaluate efficacy of intravitreal injections of ADX-2191 vs. standard of care in the prevention of PVR. Primary intraocular lymphoma is another indication under evaluation.
“ADX-2191 represents a novel therapeutic approach that we believe has the potential to decrease the development of scar tissue that characterizes PVR, breaking the cycle of complex reattachment surgeries and severe vision loss that often are a consequence of this devastating disease. ADX-2191 has the potential to be the first pharmacological prophylaxis to prevent retinal detachment associated with PVR,” Todd C. Brady, MD, PhD, president and CEO of Aldeyra, said in the release.