RegeneRx Biopharmaceuticals, Inc. (OTC: RGRX) ("the Company" or "RegeneRx") 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 trial expenses, and eligibility of FDA research grants for clinical trials.
"Orphan designation offers us a number of opportunities that would not otherwise have been available. It is an important milestone -- the result of the significant and growing body of data supporting Tβ4's development for this serious disorder, often caused by the herpes zoster virus and diabetes mellitus. In a previous physician-sponsored clinical study with RGN-259 (our preservative-free, sterile, ophthalmic eye drop whose active ingredient is Tβ4), the drug candidate stimulated healing within 4-8 weeks in patients with NK who had non-healing corneas for a minimum of six weeks to over a year. Our clinical experience to date also indicates that RGN-259 is safe, well-tolerated, and significantly improves patient comfort," explained J.J. Finkelstein, RegeneRx's president & CEO.
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