FDA approves Oxervate developed by Domp? for treatment of neurotrophic keratitis
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Last Update: 2020-06-11
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Source: Internet
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Author: User
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neurotrophic keratitis is a rare degenerative disease caused by loss of cornea sensationLoss of cornea sensation softens the cornea's surface, including thinning of the cornea, ulceration, and perforation in severe casestoday, the U.SFDA(announced the approval of theof Domp?
, developed for the treatment of neurotrophic keratitisThis is the first FDA-approvednew drug(a treatment) for this rare eye diseasecenegerminCenegermin is a recombinant protein for human neurogrowth factor (neural growth factor, NGF)It plays an important role in the development, repair and survival of nerve cellsIn the form of eye drops for patients with neurotrophic keratitis, it can help restore the normal healing process of the eye, thereby repairing corneal damageCenegermin has been qualified and qualified for the FDA's grant of orphan medicinesIn May, it was approved by the European Unionthis FDA approval is based on two multicenter, randomized double-blind clinical trial (a total of 151 patients) In the first trial, patients were divided into three groups, one using Oxervate, the other using another eye droplet with different cenegermin concentrations, and the third group using eye water that did not contain cenegermin second trial, patients were divided into two groups, one using Oxervate and the control group using eye drops without cenegermin Patients received eye drops 6 times a day for 8 weeks results showed that in two trials, patients treated with Oxervate had 70 percent of patients who sat fully healed their corneas after 8 weeks, compared with 28 percent of those treated with out-of-cenegermin eye drops
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