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用于治疗神经营养性角膜炎的cenegermin。

Cenegermin for the treatment of neurotrophic keratitis.

作者信息

Sacchetti M, Bruscolini A, Lambiase A

机构信息

Department of Sense Organs, University Sapienza of Rome, Rome, Italy.

出版信息

Drugs Today (Barc). 2017 Nov;53(11):585-595. doi: 10.1358/dot.2017.53.11.2722395.

Abstract

The trigeminal nerve provides corneal sensitivity and trophic supply to corneal tissues. The impairment of corneal innervation leads to development of neurotrophic keratitis (NK). NK is a rare, degenerative corneal disease characterized by corneal hypo/anesthesia and development of nonhealing corneal epithelial defects and ulcers. NK is a challenging condition with high medical need due to the lack of approved treatments that can restore corneal integrity. Current treatment of NK aims at stimulating corneal healing and preventing disease progression. Cenegermin is a recombinant human nerve growth factor that was safe and well tolerated in preclinical and clinical studies. Cenegermin eye drops were safe and effective in restoring corneal integrity in two phase II clinical trials in patients with NK. The European Commission granted a full marketing authorization to cenegermin eye drops for the treatment of moderate to severe NK in July 2017.

摘要

三叉神经为角膜组织提供感觉功能和营养供应。角膜神经支配受损会导致神经营养性角膜炎(NK)的发生。NK是一种罕见的退行性角膜疾病,其特征为角膜感觉减退/缺失以及出现不愈合的角膜上皮缺损和溃疡。由于缺乏能够恢复角膜完整性的获批治疗方法,NK是一种具有高度医疗需求的挑战性疾病。目前NK的治疗旨在促进角膜愈合并防止疾病进展。西奈吉明是一种重组人神经生长因子,在临床前和临床研究中均安全且耐受性良好。在两项针对NK患者的II期临床试验中,西奈吉明滴眼液在恢复角膜完整性方面安全有效。2017年7月,欧盟委员会授予西奈吉明滴眼液治疗中重度NK的全面上市许可。

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