FDA Designates Orphan Drug for Rare Degenerative Eye Disease

Dompe announced that the FDA has designated Recombinant Human Nerve Growth Factor (rhNGF) Orphan Drug status for the treatment of neurotrophic keratitis.

rhNGF is currently being studied in the REPARO study, a randomized, double-blind trial in patients with unilateral neurotrophic keratitis with Grade 2 lesions (persistent epithelial defect) or Grade 3 lesions (corneal ulcers) that do not respond to currently available treatments. The objective of the trial is to evaluate the safety, tolerability, and effectiveness of two different doses of rhNGF compared to placebo. Patients were randomized to three different treatment arms consisting of two different doses of rhNGF and placebo.

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rhNGF is identical to the protein that is naturally produced by the body and promotes the development and survival of nerve cells, including those of the retina. The protein stimulates the growth, maintenance, and survival of nerve cells, in addition to the cells of the cornea and the retina. Treatment with rhNGF-based ophthalmic solution aims to restore the innervation of the corneal area that has been compromised by the disease in order to promote recovery of visual function.

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