Aldeyra Therapeutics announced that the US Food and Drug Administration (FDA) has granted fast track designation to ADX-2191 for the prevention of proliferative vitreoretinopathy (PVR). PVR is a serious, sight-threatening condition with no approved treatment.
“Fast track designation is an important milestone for our retinal disease platform, and promising news for PVR patients,” said Todd C. Brady, M.D., Ph.D., President and Chief Executive Officer of Aldeyra.
“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.”
PVR, a rare inflammatory disorder of the retina that leads to severe retinal scarring and blindness, occurs most commonly following retinal detachment repair surgery or ocular injury. 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.
The fast track designation is designed to facilitate the development and expedite the review of drugs that treat serious conditions, potentially accelerating patient access to new therapies.
“Fast track designation enables us to engage in more frequent communications with the FDA to discuss our development plan for ADX-2191, and provides eligibility for Priority Review and rolling New Drug Application submission,” said David J. Clark, M.D., Chief Medical Officer of Aldeyra. “We look forward to working with the FDA as we advance ADX-2191 into Phase 3 development.”
ADX-2191, an intravitreal formulation of methotrexate, has been granted orphan drug designation for the prevention of proliferative vitreoretinopathy (PVR). The observed clinical activity of ADX-2191 in patients with PVR is believed to be the result of down-regulation of aberrant retinal cell proliferation and activity, thereby leading to reduced retinal scarring that is characteristic of PVR. Aldeyra retains an exclusive license to certain patents related to the use of ADX-2191 for the prevention of PVR.
Source: Company Press Release