Industry News

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, 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.

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.