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Dompe announces the Food and Drug Administration (FDA) has granted orphan drug designation to its rhNGF-based treatment for neurotrophic keratitis
Date:7/23/2014

NEW YORK, July 23, 2014 /PRNewswire/ -- Dompe, a leader in R&D for new therapeutic solutions for the treatment of rare diseases, announces that rhNGF (Recombinant Human Nerve Growth Factor) has been designated as an orphan drug by the American Food and Drug Administration (FDA).

The candidate drug, developed by the research of Dompe, has been designated as an orphan drug for the treatment of neurotrophic keratitis, a degenerative corneal disease that affects less than 1 in 5,000 people1 and is currently without a cure. This is the second orphan drug designation by the FDA for rhNGF, after the recent designation for the treatment of retinitis pigmentosa, a rare genetic disease that affects more than 1 million people worldwide2.

This acknowledgment represents an important step in the clinical development of the drug, which is currently in advanced stages of experimentation for the treatment of neurotrophic keratitis in the REPARO study. The randomized, double-blind study includes 39 centers in 9 European countries (Italy, Great Britain, Germany, France, Belgium, Spain, Portugal, Poland, 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 objective of the trial is to evaluate the safety, tolerability, and effectiveness of two different doses of recombinant human nerve growth factor (rhNGF) compared to the placebo. The more than 170 patients enrolled in the study are divided into three different groups, treated respectively with two different doses of rhNGF and with the placebo. The
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