Dompé's Oxervate gains FDA approval as first drug treatment for neurotrophic keratitis

The FDA announced the approval of Dompé Farmaceutici's topical eye drop Oxervate (cenegermin-bkbj) as the first drug treatment in the US for neurotrophic keratitis. Wiley Chambers, an ophthalmologist in the agency's Center for Drug Evaluation and Research, noted "in the past, it has often been necessary to turn to surgical interventions," adding the clearance of Oxervate "provides a novel topical treatment and a major advance that offers complete corneal healing for many of these patients."

Results supporting the approval come from two studies that included 151 patients with neurotrophic keratitis, with subjects administered either Oxervate, an eye drop with a different concentration of cenegermin or an eye drop not containing the drug's active ingredient. Across the two studies, data showed that complete corneal healing in eight weeks was demonstrated in 70 percent of patients treated with Oxervate compared to 28 percent of patients treated with an eye drop not containing the drug's active ingredient.

"Oxervate represents the first therapy from Dompé that will be available in the [US]," noted Sergio Dompé, chairman of the company, with the product expected to be launched by early 2019. The therapy, which was approved last year by regulators in Europe for the treatment of moderate-to-severe neurotrophic keratitis, is a recombinant human nerve growth factor structurally identical to the nerve growth factor protein produced in the human body.

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