The US Food and Drug Administration (FDA) has approved the first drug — Oxervate (cenegermin) to Dompé farmaceutici SpA —for neurotrophic keratitis, which is a rare eye disease that affects the cornea.
Eye
“While the prevalence of neurotrophic keratitis is low, the impact of this serious condition on an individual patient can be devastating,” said Dr Wiley Chambers, an ophthalmologist in the FDA’s Center for Drug Evaluation and Research. “In the past, it has often been necessary to turn to surgical interventions; these treatments are usually only palliative in this disease. Today’s approval provides a novel topical treatment and a major advance that offers complete corneal healing for many of these patients.”
Safety and efficacy of Oxervate was assessed in a study including a total of 151 patients with neurotrophic keratitis in two, eight-week randomised controlled multicentre, double-masked studies. In these studies, the eye drop treatment was found to heal the cornea completely within eight weeks in about 70% of patients, compared with only 28% of patients who were treated without cenegermin — the active ingredient in Oxervate.
“There are numerous clinical conditions that can lead to subnormal corneal sensitivity and neurotrophic keratitis due to damage to the rich nerve supply provided to the eye via the trigeminal nerve,” commented Reza Dana, professor of Ophthalmology at Harvard Medical School, and director of the Cornea Service and senior scientist at the Massachusetts Eye and Ear, Boston, USA. “In the more severe cases, neurotrophic keratitis can lead to ulcers, corneal necrosis and perforation, and visual loss. Considering the possible severity of neurotrophic keratitis, and the lack of good response to standard therapies in many cases, having a valid therapeutic option that can directly promote nerve function is a major contribution to the field and to the community of ophthalmologists, not to mention the many patients suffering from this condition.”