RARE Daily

FDA Grants Fast Track Designation to Aldeyra Therapeutics for PRV Therapy

September 25, 2019

Rare Daily Staff

The U.S. Food and Drug Administration granted Aldeyra Therapeutics fast track designation for ADX-2191, the company’s experimental therapy for the prevention of proliferative vitreoretinopathy (PVR), a serious, sight-threatening condition.

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.

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 percent of PVR cases result in severe uncorrectable vision loss, and 76 percent of PVR patients suffer from at least moderate uncorrectable vision loss.

ADX-2191, an intravitreal formulation of methotrexate, has been granted orphan drug designation for the prevention of 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 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.

“Fast track designation is an important milestone for our retinal disease platform, and promising news for PVR patients,” said Todd Brady, CEO 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.”

Photo: Todd Brady, CEO of Aldeyra

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