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On August 14, Cenegermin eye drops were approved for sale in China to treat neurotrophic corneitis.
the drug, developed by Dompé Pharmaceuticals, is one of the first clinically urgent overseas drugs.
neurotrophic cornealitis is a rare eye disease caused by herpes or other infections, eyelid damage, eye or neurosurgery, and systemic diseases such as diabetes that impair corneal perception and nutrition.
if not detected and controlled in a timely manner, the disease gradually worsens and leads to persistent epithal defects, corneal ulcers, substring dissolution, perforation and vision loss.
Cenegermin eye drop is a local surface drop of eye drops, given 6 times a day for 8 weeks to treat neurotrophic corneitis.
14, 2015, Cenegermin was identified by the European Union as an orphan drug.
in the European Union in July 2017 and in the United States in August 2018, the first FDA-approved treatment for neurotrophic corneitis.
Cenegermin is a new type of recombined human neurogenesist factor (rhNGF) that is structurally identical to the neurogenespheric factor (NGF) protein produced in the human body and contained in eye tissue.
this endo-protein provides strong support for corneal integrity through a variety of mechanisms.
NGF directly on corneal cells to stimulate cell growth and survival.
addition, NGF is known to bind to the subjects in the tear glands, promote tear secretion, and provide lubrication and natural protection for the eyes from pathogens and injuries.
protein has been shown to support corneal nerve control, a nerve function that has been lost in neurotrophic cornealitis.
and safety of Cenegermin have been confirmed in two separate double-blind randomized multi-center controlled clinical trials.
the project had the largest population of neurotrophic cornea patients in randomized controlled trials.
both trials studied Cenegermin Senegigmin eye drop monotherapy (20 μg/mL) in patients with moderate or severe neurotrophic corneitis and compared it with treatments without preservative artificial tear fluid-like epinoratives.
study conducted in Europe, NGF0212 randomly assigned 52 patients to subgroups.
after eight weeks of treatment, about 72% of the patients in the treatment group were completely cured.
study conducted in the United States, NGF0214 randomly assigned 24 patients to subgroups, of which 65.2% were completely cured.
follow-up to the REPARO study, which found that about 82 percent of patients who were cured after an eight-week course of treatment remained stable for a year.
Cenegermin is well-to-do in clinical trials.
is the most common adverse reaction, with about 16 percent of patients reporting eye pain, which may be related to loss of consciousness due to illness to recover.
adverse events reported in more than 5% of patients included swelling (inflammation), increased tear fluid (increased tear secretion) and eye congestion.
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