2017年8月14日，意大利生物制药公司Dompe宣布，欧盟委员会(EC)已批准Oxervate(cenegermin滴眼液)用于中度至重度神经营养性角膜炎(neurotrophic keratitis，NK)成人患者的治疗。Oxervate以滴眼液的形式给药，可帮助恢复眼部的正常愈合过程、修复角膜损伤。
Oxervate的上市剂型为滴眼液，规格为20mg/mL
成份
Oxervate的活性成分Cenegermin，是人类神经生长因子(NGF)的重组版本，由诺贝尔奖获得者Rita Levi Montalcini发现。该蛋白主要参与神经细胞的发育和生长。
作用机制
具有神经营养性角膜炎患者的物质水平低于正常水平，包括由三叉神经提供的生长因子，该因子在角膜细胞生长和存活中起重要作用。Oxervate的活性成分cenegermin是一种称为神经生长因子的人类生长因子复制体。当神经营养性角膜炎患者用药时，cenegermin可帮助恢复眼部的正常愈合过程，并修复角膜的损伤。
适应证
Oxervate是一种用于治疗神经营养性角膜炎
用法与用量
Oxervate以滴眼液的形式给药。推荐剂量为每2小时1次，每天6次，治疗应持续8周。
Oxervate只能用处方获得，由眼科专家监督和治疗。进一步的信息，请详见包装说明书
临床研究
两项主要研究表明，Oxervate有助于修复角膜的损伤，这些研究入组了204例中度至重度神经营养性角膜炎成年患者。在第一项研究中，74%（50例中有37例）的患者使用Oxervate治疗8周后角膜完全愈合；相比之下，使用不含活性成分的同样滴眼液配方治疗的患者只有43%（51例中有22例）角膜愈合。在第二项研究中，使用Oxervate治疗的治愈率为70%（23例中的16例），而使用安慰剂组治疗的只有29%（24例中的7例）的治愈率。

 
CHMP Backs Cenegermin (Oxervate) for Neurotrophic Keratitis
The European Medicines Agency's (EMA's) Committee for Medicinal Products for Human Use (CHMP) recommended granting marketing authorization for cenegermin (Oxervate, Dompé farmaceutici S.p.A.) for the treatment of adults with moderate (persistent epithelial defect) or severe (corneal ulcer) neurotrophic keratitis on May 18, 2017.
Cenegermin was designated as an orphan medicinal product on December 14, 2015, and was reviewed under the agency's accelerated assessment program. It will be available as an eye drop solution containing 20 microgram/mL.
Neurotrophic keratitis is a rare eye disease that can result in blindness. "Patients with neurotrophic keratitis have damage to the trigeminal nerve (one of the nerves that supplies the eye). This results in reduced or lack of sensation in the cornea (the clear layer at the front of the eye), and reduced production of the substances that play an important role in repairing damage and ensuring survival of cornea cells," according to an EMA news release.
No satisfactory treatment currently exists for neurotrophic keratitis. On the basis of the extent of their disease, patients may receive eye drops to lubricate the eye, antibiotics to treat eye infections, and protective contact lenses. Some patients may undergo surgery.
Cenegermin is a recombinant form of human nerve growth factor that stimulates corneal epithelial cell growth and survival. It stimulates corneal healing and restores the surface integrity of the eye in patients with persistent epithelial defects or corneal ulcers as a result of neurotrophic keratitis.
"Oxervate is produced by 'recombinant DNA technology.' It is made by bacteria into which a gene (DNA) has been introduced, that enables the bacteria to produce human nerve growth factor," according to the EMA news release.
The recommendation follows consideration of data from two phase 2 clinical trials in 204 patients with moderate and severe neurotrophic keratitis. In both studies, more patients treated with cenegermin achieved complete corneal healing after 8 weeks compared with patients treated with placebo.
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产地国家：德国
原产地英文商品名:
Oxervate 20mg/mL（1ml）/vial 7vial/box
原产地英文药品名:
cenegermin
中文参考商品译名:
Oxervate滴眼液 20毫克/毫升（1毫升）/瓶 7瓶/盒
中文参考药品译名:
重组人神经生长因子
生产厂家英文名:
DOMPÉ FARMACEUTICI S.p.A