FDA Approves First Drug for Neurotrophic Keratitis

Share this content:
FDA Approves First Drug for Neurotrophic Keratitis
FDA Approves First Drug for Neurotrophic Keratitis

THURSDAY, Aug. 23, 2018 (HealthDay News) -- Oxervate (cenegermin) has been approved by the U.S. Food and Drug Administration to treat neurotrophic keratitis, a rare degenerative disease of the cornea.

This application received priority review by the FDA and was approved under the designation of orphan drug.

Oxervate, produced as an eyedrop, was evaluated in two clinical studies involving a total of 151 patients 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 patients 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, ocular hyperemia, eye inflammation, and increased lacrimation.

"While the prevalence of neurotrophic keratitis is low, the impact of this serious condition on an individual patient can be devastating," Wiley Chambers, M.D., an ophthalmologist in the FDA's Center for Drug Evaluation and Research, said in a statement. "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 is produced by the Italian firm Dompé farmaceutici.

More Information

Share this content:

is free, fast, and customized just for you!




Already a member?

Sign In Now »

Trending Activities

All Professions

Drug Lookup

Browse drugs by: BrandGenericDisease

More in Home

CDC: Progress in HIV Prevention Has Stalled in the United States

CDC: Progress in HIV Prevention Has Stalled in ...

Agency says effective HIV prevention, treatment not reaching those who could most benefit

AAAAI: Egg Oral Immunotherapy Shows Sustained Benefit in Children

AAAAI: Egg Oral Immunotherapy Shows Sustained Benefit in ...

All children with sustained unresponsiveness ingested concentrated and baked egg

Prenatal Vitamin Intake in Early Pregnancy May Cut Autism Risk

Prenatal Vitamin Intake in Early Pregnancy May Cut ...

ASD risk down for children whose mothers took prenatal vitamins during first month of pregnancy

is free, fast, and customized just for you!




Already a member?

Sign In Now »