Posted by Michael Wonder on 24 Sep 2019
Aldeyra Therapeutics receives fast track designation for ADX-2191 for the prevention of proliferative vitreoretinopathy
24 September 2019 - Aldeyra Therapeutics today announced that the U.S. FDA has granted fast track designation to ADX-2191 for the prevention of proliferative vitreoretinopathy.
Proliferative vitreoretinopathy (PVR) is a serious, sight-threatening condition with no approved treatment. More than 50% of PVR cases result in severe uncorrectable vision loss, and 76% of PVR patients suffer from at least moderate uncorrectable vision loss.
Aldeyra expects to initiate its adaptive Phase 3 GUARD Trial of ADX-2191 for the prevention of PVR in the fourth quarter of 2019. The trial will compare recurrence rates of PVR-related retinal detachment across patients treated with ADX-2191 or standard of care following surgical repair of retinal detachment.
