FDA approves first drug for neurotrophic keratitis

The US Food and Drug Administration yesterday approved the first drug, Oxervate (cenegermin), for the treatment of neurotrophic keratitis, a rare disease affecting the cornea (the clear layer that covers the colored portion of the front of the eye).

The FDA granted approval of Oxervate to Dompé Farmaceutici, an Italian family-owned enterprise that has been run by a long line of Dompés stretching back to 1853. The drug was approved in Europe in July 2017.

“While the prevalence of neurotrophic keratitis is low, the impact of this serious condition on an individual patient can be devastating,” said 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,” Dr Chambers added.