January 07, 2014
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FDA grants orphan drug designation for neurotrophic keratopathy therapy

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RegeneRx Biopharmaceuticals has received orphan drug designation from the U.S. Food and Drug Administration’s Office of Orphan Products Development for thymosin beta 4 to treat neurotrophic keratopathy, according to a press release.

A previous clinical study of RGN-259, RegeneRx’s preservative-free, sterile ophthalmic eye drop whose active ingredient is thymosin beta 4, found that the drug candidate stimulated healing within 4 to 8 weeks in neurotrophic keratopathy patients who had nonhealing corneas for at least 6 weeks and up to more than 1 year, J.J. Finkelstein, president and CEO of RegeneRx, said in the release.

The designation is for drugs that treat diseases with a prevalence of less than 200,000 patients in the U.S. and provides 7 years of extended marketing exclusivity, waiver of FDA user fees, tax credits for qualified clinical trial expenses and eligibility of FDA research grants for clinical trials.