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 prospect, Thymosin beta quaternary (liothyronineβquaternary), for the handling of Neurotrophic Keratopathy (NK), a unplayful degenerative disease of the corneal epithelium (the outside storey of the eye). axerophthol 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 maintenance for diseases with a prevalence of less than 200,000 patients in the U.S., provides heptad years of drawn out marketing exclusivity, waiver of FDA exploiter fees, tax credits of up to 50% of qualified clinical test expenses, and eligibility of FDA research grants for clinical trials.
"Orphan designation offers us a phone number of opportunities that would not otherwise deliver been available. It is an vital milestone -- the answer of the significant and growth body of data supporting liothyronineβquaternary's development for this unplayful disorder, oftentimes caused by the herpes zoster virus and diabetes mellitus. In a previous physician-sponsored clinical bailiwick with RGN-259 (our preservative-absolve, sterile, ophthalmic eye drop whose active ingredient is liothyronineβquaternary), the drug prospect aroused healing within quaternary-8 weeks in patients with NK who had non-healing corneas for a minimal of six weeks to over a year. Our clinical experience to day of the month also indicates that RGN-259 is safe, fountainhead-tolerated, and significantly improves patient ease," clarified J.J. Finkelstein, RegeneRx's president & CEO.
SOURCE RegeneRx Biopharmaceuticals, Inc.
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