The U.S. Food and Drug Administration granted Aldeyra Therapeutics Inc. a fast-track designation for ADX-2191, a preventive treatment for a rare, blinding eye disorder.
The disorder, called proliferative vitreoretinopathy, or PVR, leads to severe uncorrectable vision loss in more than half of all cases and at least moderate vision loss in three-quarters of patients, Aldeyra said in a Sept. 24 release.
Following retinal detachment surgery or injury to the eye, scarring can lead to blindness, and the Lexington, Mass.-based company's ADX-2191 is designed to slow the inflamed reaction that leads to PVR.
Aldeyra plans to begin a phase 3 study in the fourth quarter comparing rates of PVR in patients taking ADX-2191 versus the standard of care.
"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," Aldeyra Chief Medical Officer David Clark said.
Aldeyra picked up ADX-2191 when it acquired Helio Vision in January.
