FDA grants orphan drug designation for neurotrophic keratopathy therapy

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, (Read more...)

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