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FDA fast tracks potential treatment to prevent proliferative vitreoretinopathy
The FDA has granted fast track designation to ADX-2191 for the prevention of proliferative vitreoretinopathy, Aldeyra Therapeutics announced in a press release.
A phase 3 trial of ADX-2191 is planned for the fourth quarter and will compare recurrence rates of proliferative vitreoretinopathy-related retinal detachment in those treated with ADX-2191 compared with those treated with standard of care following surgical repair of retinal detachment.
“Fast track designation is an important milestone for our retinal disease platform and promising news for PVR patients,” Todd C. Brady, MD, PhD, president and CEO of Aldeyra, said in the release. “The FDA’s decision underscores the potential of ADX-2191 to prevent this devastating condition and creates the framework for ADX-2191 to reach the market promptly if approved.”