First Drug Cenegermin (Oxervate) Approved for Rare Eye Disease
THURSDAY, Aug. 23, 2018 -- Oxervate (cenegermin) has been approved by the U.S. Food and Drug Administration to treat neurotrophic keratitis, a rare disease of the eye's cornea.
The cornea is the clear layer that covers the colored portion at the front of the eye.
Neurotrophic keratitis affects fewer than five in 10,000 people, the FDA said. The disease, causing loss of corneal sensation, leads to damage of this vital part of the eye.
"While the prevalence of neurotrophic keratitis is low, the impact of this serious condition on an individual patient can be devastating," Dr. Wiley Chambers, an ophthalmologist in the FDA's Center for Drug Evaluation and Research, said in an agency news release.
Oxervate, produced as an eyedrop, was evaluated in a clinical study involving 151 people with neurotrophic keratitis. Some participants were given Oxervate, while others were given a placebo eye drop. Complete corneal healing was reported among 70 percent of people treated with Oxervate, compared with 28 percent of those given the placebo, the FDA said.
The most common side effects of the drug included eye pain, enlarged blood vessels in the eye, eye inflammation and watery eyes.
Oxervate is produced by the Italian firm Dompé farmaceutici.
Visit the FDA to learn more.
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Posted: August 2018