The Food and Drug Administration (FDA) has granted Fast Track designation to ADX-2191 (Aldeyra Therapeutics) for the prevention of proliferative vitreoretinopathy (PVR).
PVR is a rare inflammatory disorder of the retina that leads to severe retinal scarring and blindness and often occurs following surgeries for retinal detachment repair or after ocular injury. ADX-2191 is an intravitreal formulation of methotrexate that is believed to inhibit cell growth resulting in diminished scar formation, which is commonly seen in PVR.
The Company is expecting to initiate a phase 3 trial (GUARD) of ADX-2191 for the prevention of PVR in the fourth quarter of 2019. The FDA previously granted Orphan Drug designation to ADX-2191 for the prevention of PVR in April 2018.
“Fast track designation is an important milestone for our retinal disease platform, and promising news for PVR patients,” said Todd C. Brady, MD, PhD, 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.”
For more information visit aldeyra.com.