US regulators have approved the first drug to treat neurotrophic keratitis, a rare degenerative disease affecting the cornea.
Dompé farmaceutici’s Oxervate (cenegermin) is the first-ever application of a human nerve growth factor as drug or treatment, and is the first-ever topical biologic medication approved in ophthalmology.
Neurotrophic keratitis results from a loss of corneal sensation, which causes progressive damage to the top layer of the cornea, including corneal thinning, ulceration and perforation in severe cases.
The prevalence of the condition has been estimated to be less than five in 10,000 individuals.
In clinical trials, complete corneal healing in eight weeks was demonstrated in 70 percent of patients treated with Oxervate compared to 28 percent of those who did not receive the drug.
"Neurotrophic keratitis can be disabling, hard to treat, and many patients do not respond well to existing therapies," said Reza Dana, Professor of Ophthalmology at Harvard Medical School, director of the Cornea Service, senior scientist at the Massachusetts Eye and Ear, and Dompé medical advisor.
"By directly promoting corneal healing, Oxervate has the potential to change the way neurotrophic keratitis is treated, and may eventually result in a new standard of care for patients with this rare condition."
Oxervate was granted a priority review and also carries orphan drug status.