Aldeyra’s ADX-2191 Receives FDA’s Fast Track Designation to Prevent Proliferative Vitreoretinopathy

Shots:

• The US FDA has granted FT designation to ADX-2191 for the prevention of proliferative vitreoretinopathy and provides it eligibility for Priority Review and rolling NDA submission
• The FDA’s FT designation facilitates the development and expedites the review of drugs that treat serious conditions, potentially accelerating patient access to new therapies
• ADX-2191 is an intravitreal formulation of methotrexate and has received FDA’s ODD for preventing PVR with its expected onset of P-III GUARD Trial in Q4’19. The study will evaluate recurrence rates of PVR-related retinal detachment in patients treated with ADX-2191 or SoC following surgical repair of retinal detachment

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