Patients who experience loss of corneal sensation from damage to the trigeminal nerve finally have a potential remedy that doesn’t require surgery. Yesterday the FDA announced its approval of Oxervate (cenegermin) to treat neurotrophic keratitis; the drug is manufactured by Dompé Farmaceutici, based in Milan.
“In the past, it has often been necessary to turn to surgical interventions; these treatments are usually only palliative in this disease,” said Wiley Chambers, MD, an ophthalmologist in the FDA’s Center for Drug Evaluation and Research in an agency press release. “Today’s approval provides a novel topical treatment and a major advance that offers complete corneal healing for many of these patients.”
Most commonly caused by herpes simplex or zoster infection, neurotrophic keratitis induces anesthesia of the cornea and increases the patient’s risk of corneal thinning, ulceration and, in severe cases, perforation.
The safety and efficacy of topical Oxervate was demonstrated in 151 patients in two randomized controlled trials of eight weeks’ duration, each using a 6x/day dosing regimen. Complete corneal healing was demonstrated in 70% of patients treated with Oxervate vs. 28% in controls, according to the FDA. The most common adverse reactions were pain, hyperemia, inflammation and increased lacrimation.