Dompé farmaceutici bags Oxervate FDA approval for neurotrophic keratitis
Oxervate FDA approval : Italian pharma company Dompé farmaceutici has bagged an approval for Oxervate (cenegermin) eye drops from the US Food and Drug Administration (FDA) for the treatment of a rare eye disease called neurotrophic keratitis.
Oxervate is now the first US FDA approved drug for neurotrophic keratitis treatment.
A degenerative disease, neurotrophic keratitis results from a loss of corneal sensation which impairs corneal health. Subsequently, the loss of corneal sensation leads to progressive damage to the cornea’s top layer, including corneal thinning, perforation and ulceration in severe cases, said the FDA.
The rare eye disease has been estimated to affect less than five in 10,000 people.
Commenting on Oxervate FDA approval, Wiley Chambers – an ophthalmologist at FDA Center for Drug Evaluation and Research, said: “While the prevalence of neurotrophic keratitis is low, the impact of this serious condition on an individual patient can be devastating.
“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.”
Oxervate FDA approval was driven by two eight-week double-masked safety and efficacy trials of the biotechnological drug in 151 neurotrophic keratitis patients.
Oxervate, which is a topical eye drop containing cenegermin, in both the studies could deliver complete corneal healing in eight weeks in 70% of patients compared to 28% of patients treated without cenegermin.
The FDA advised that the most common adverse reactions seen in patients subjected to Oxervate include eye pain, ocular hyperemia – which is enlarged blood vessels in the white area of the eyes, eye inflammation and increased lacrimation – which is watery eyes.
Previously Oxervate was granted Orphan Drug designation and Priority Review designation by the US FDA.
In July 2017, Oxervate was approved by the European Commission for the treatment of moderate to severe neurotrophic keratitis.
For more pharma regulatory news like the Oxervate FDA approval for neurotrophic keratitis treatment, keep following PharmaNewsDaily.com.