Oxervate(cenegermin-bkbj)-为首个神经营养性角膜炎药物
近日，FDA批准首个用于治疗神经营养性角膜炎的药物Oxervate（cenegermin），神经营养性角膜炎是一种罕见病，其对角膜（覆盖眼睛前部彩色部分的透明层）有影响。
FDA药物评价与研究中心的眼科专家Chambers博士称：虽然神经营养性角膜炎的发病率较低，但这种严重疾病对患者的影响可能是灾难性的。以往，手术介入往往是必要的，对于这种疾病，这些治疗手段往往只起到缓解作用。但今日的批准提供了一种新的局部治疗方法，这也是一项重大进展，可以为众多这样的患者提供彻底的角膜治疗。
批准日期：2018年8月22日  研发公司：Dompe farmaceutici SpA
OXERVATETM（cenegermin-bkbj）局部用眼用溶液，眼科使用
美国最初批准：2018年
作用机制
神经生长因子是参与分化和维持的内源蛋白通过特定的高亲和力（即TrkA）和低亲和力（即p75NTR）起作用的神经元神经生长因子受体在眼前段支持角膜神经支配和诚信。
适应症和用法
OXERVATE是一种重组人神经生长因子，用于治疗神经营养性角膜炎。
剂量和给药
受影响的眼睛中滴一滴OXERVATE，每天2次，间隔2次，持续8周。
剂量形式和强度
眼科溶液：多剂量小瓶中的cenegermin-bkbj 0.002％（20mcg/mL）。
禁忌症
没有。
警告和注意事项
患者应在使用OXERVATE前摘除隐形眼镜，并在重新插入前滴注剂量后等待15分钟。
不良反应
最常见的不良反应（发生率> 5％）是眼痛，眼部充血，眼部炎症和泪液增加。
包装提供/存储和处理
OXERVATE（cenegermin-bkbj）眼用溶液，0.002％（20mcg/mL），是无菌的，在多剂量小瓶中不含防腐剂的透明无色溶液，用橡皮塞封闭（不是用天然橡胶乳胶制成），而是用聚丙烯翻盖制成的铝制外壳。
OXERVATE以每周一箱的形式提供，包含7个多剂量小瓶（NDC 71981-020-07）在交付系统套件（NDC 71981-020-01）中的绝缘包装中。
交付系统套件包含8个样品瓶适配器，45个移液器，45个无菌消毒湿巾和一张剂量卡。
在从药房配药之前将每周纸箱存放在-4°F（-20°C）或更低温度的冰箱中。分发每周纸箱交付系统套件中的绝缘包装。
从药房开始配药
离开药房后5小时内，将每周纸箱存放在冰箱之间36°F至46°F（2°C至8°C），最长14天。打开的小瓶可以存储在原始的每周中冰箱中的纸箱温度在36°F到46°F（2°C到8°C）之间或室温高达77°F（25°C），最长12小时[见剂量和给药方法]。不要重新冷冻。别摇了小瓶12小时后丢弃任何未使用的部分。

完整资料附件：https://www.multivu.com/players/English/8382351-dompe-oxervate-eye-drops-fda-approval/docs/OxervateLabel_1534986447197-2032025308.pdf
Oxervate Approved for the Treatment of Neurotrophic Keratitis
Dompé announced that the Food and Drug Administration (FDA) has approved Oxervate (cenegermin-bkbj) ophthalmic solution for the treatment of neurotrophic keratitis in patients aged ≥2 years.
Neurotrophic keratitis is a rare and progressive ophthalmic disease that results from impaired function of corneal nerves. Prior to the approval, treatment was limited to symptomatic relief such as artificial tears, antibiotics, autologous serum-derived eye drops, tarsorrhaphy, and botulinum-induced ptosis, or surgical interventions (eg, conjuctival flap surgeries, corneal transplants).
“In the past, it has often been necessary to turn to surgical interventions; these treatments are usually only palliative in this disease, " said Wiley Chambers, MD, an ophthalmologist in the FDA's Center for Drug Evaluation and Research. "Today's approval provides a novel topical treatment and a major advance that offers complete corneal healing for many of these patients.”
Oxervate,a recombinant form of human nerve growth factor (rhNGF), is structurally similar to endogenous NGF protein, which acts directly on corneal epithelial cells to stimulate growth and survival and binds to receptors on lacrimal glands to promote tear production.
The safety and efficacy of Oxervate were evaluated in 2 independent, double-masked, randomized, multicenter, controlled clinical trials involving patients with moderate to severe neurotrophic keratitis. In Study NGF0212 (N=104), 72% of patients treated with Oxervate for 8 weeks had complete corneal healing, defined as absence of staining of the corneal lesion and no persistent staining in the rest of the cornea after 8 weeks of treatment; 80% of these patients remained healed after 1 year. In Study NGF0214 (N=48), 65.2% of patients treated with Oxervate had complete corneal healing at week 8; recurrences occurred in 14% of healed patients.
With regard to safety, eye pain, ocular hyperemia, eye inflammation, and increased lacrimation were the most common adverse events seen with Oxervate.
Oxervate will be available as a 0.002% preservative-free solution in multi-dose vials in 7-count weekly cartons.