RegeneRx Announces Orphan Drug Designation for Tβ4 for Treatment of Neurotrophic Keratopathy

RegeneRx Biopharmaceuticals

announced that it has received Orphan Drug designation from U.S. FDA's Office of Orphan Products Development (OOPD) for its drug candidate, Thymosin beta 4 (Tβ4), for the treatment of Neurotrophic Keratopathy (NK), a serious degenerative disease of the corneal epithelium (the outside layer of the eye). A reduction in corneal sensitivity or complete corneal anesthesia is the hallmark of this disease and is responsible for producing corneal ulceration, perforation, pain and impaired vision. The designation, for novel drugs to treat diseases with a prevalence of less than 200,000 patients in the U.S., provides seven years of extended marketing exclusivity, waiver of FDA user fees, tax credits of up to 50% of qualified clinical