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August 24, 2018

Dompé’s Oxervate gets approval to treat neurotrophic keratitis in US

Italian biopharmaceutical firm Dompé farmaceutici has secured approval from the US Food and Drug Administration (FDA) for the use of its Oxervate medicine to treat neurotrophic keratitis.

Italian biopharmaceutical company Dompé farmaceutici has secured approval from the US Food and Drug Administration (FDA) for the use of its Oxervate medicine to treat neurotrophic keratitis.

Oxervate is said to be the first FDA-approved drug for this rare, degenerative disease, which causes corneal scarring and vision loss.

The drug is based on a recombinant human nerve growth factor (rhNGF) called cenegermin-bkbj. This nerve growth factor is similar in structure to a natural one present in human body.

FDA Center for Drug Evaluation and Research ophthalmologist Wiley Chambers said: “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.”

“Today’s approval provides a novel topical treatment and a major advance that offers complete corneal healing.”

Oxervate’s safety and efficacy were assessed in two randomised, controlled, multi-centre, double-masked clinical studies conducted in a total of 150 subjects over eight weeks.

The first study enrolled patients with neurotrophic keratitis in only one eye, while the second study involved subjects who were affected in both eyes. Oxervate eye drops were administered six times daily.

Patients in the first trial were treated with Oxervate, an eye drop with a different concentration of cenegermin, or an eye drop without cenegermin.

During the second study, participants were randomised to receive either Oxervate or an eye drop without cenegermin.

Data from both the trials showed that 70% of the patients treated with Oxervate achieved complete corneal healing in eight weeks, compared to 28% who were administered eye drop without cenegermin.

The most common adverse reactions associated with Oxervate were eye pain, ocular hyperaemia, eye inflammation and increased lacrimation.

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