The US FDA has approved the first drug to treat neurotrophic keratitis, a degenerative condition that affects the eyes. Approval of the drug, called Oxervate (cenegermin), is granted to Oxervate to Dompé farmaceutici SpA. For more detailed information, you can read the source press release here, at the FDA’s website.
About Neurotrophic Keratitis
Neurotrophic keratitis is a condition that causes progressive damage to the eye’s cornea (clear covering). According to NICE, it is linked to damage of the nerve that connects to the cornea, and, as a result, the eye can suffer from a loss of sensation and difficulty healing, which can lead to more damage over time.
Neurotrophic keratitis may be caused by several different factors, including viral infections, eye injuries, and systemic conditions such as diabetes or multiple sclerosis, amongst other causes.
Research into Oxervate (cenegermin)
Oxervate is a topical eye drop that contains an active ingredient called cenegermin. Two clinical trials involving a combined total of 151 patients were completed to investigate how safe and effective Ocervate is. Both were randomised, controlled, double-masked studies that involved eye drop treatment six times daily for a period of eight weeks.
The first study contained three groups of patients; one group that was given Oxervate, another that was given eye drops that contained cenegermin in another concentration, and a third that was given eye drops without any cenegermin. This study only involved patients affected by neurotrophic keratitis in one eye.
The second study included two groups of patients; one that was given Oxervate, and another that was given eye drops without cenegermin. Patients in this study suffered from neurotropic keratitis in both eyes and therefore received treatment in both.
The results of the two studies showed that, following the eight-week treatment period, 70% of patients who were given Oxervate showed complete corneal healing, compared to 28% of patients given eye drops that didn’t contain cenegermin.
For more information, you can view the source article at the FDA’s website here.