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The FDA has designated Dompé’s rhNGF (recombinant human nerve growth factor) as an orphan drug for the treatment of neurotrophic keratitis.
Milan-The FDA has designated Dompé’s rhNGF (recombinant human nerve growth factor) as an orphan drug for the treatment of neurotrophic keratitis.
This is the second orphan drug designation by the FDA for rhNGF, after the recent designation for the treatment of retinitis pigmentosa.
The drug is currently in advanced stages of experimentation for neurotrophic keratitis in the REPARO study. The randomized, double-blind study includes 39 centers in nine European countries-Italy, Great Britain, Germany, France, Belgium, Spain, Portugal, Poland, and Hungary-and involves patients suffering from unilateral neurotrophic keratitis with grade 2 lesions (persistent epithelial defect) or grade 3 lesions (corneal ulcers) that do not respond to the currently available medical treatment.
The goal of the trial is to examine the safety, tolerability, and effectiveness of two different doses of rhNGF compared with placebo. The more than 170 patients enrolled in the study are divided into three different groups, treated respectively with two different doses of the treatment and with placebo. The secondary objectives include the evaluation of corneal lesion healing, improvement in visual acuity, and the sensitivity of the cornea.
“We are particularly proud of this new FDA designation, which represents an important recognition of our research and development efforts in the field of ophthalmology on a global scale, particularly in North America,” said Eugenio Aringhieri, chief executive officer of the Dompé Group. “It is another confirmation of the constant dialogue with the international regulatory agencies in order to bring health issues that still need to be resolved to the forefront as well as possible therapeutic solutions for diseases that are currently without a cure.
“This is the direction that the efforts of our group is taking, focused on the identification of innovative drugs to protect patients around the world,” he added.
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