July 23, 2014
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Dompe receives orphan drug status for neurotrophic keratitis treatment
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The U.S. Food and Drug Administration has granted orphan drug designation for a recombinant human nerve growth factor-based treatment.
Recombinant human nerve growth factor (rhNGF, Dompe) is indicated for the treatment of neurotrophic keratitis, a corneal disease that impacts fewer than 1 in 5,000 people, according to a press release.
Currently, the safety and effectiveness of the drug are being evaluated through the REPARO study, which is taking place across 39 centers in nine European countries.
The FDA and European Medicines Agency previously designated rhNGF as an orphan drug for the treatment of retinitis pigmentosa, which affects more than 1 million people worldwide, according to the release.