青光眼和白内障以及黄斑变性是三大致盲的严重眼科疾病。其主要病因是眼内产生的房水无法正常排出，导致眼压升高。长期的眼压升高会压迫视神经使其受损，进而造成视力衰退，甚至失明。近日，Valeant Pharmaceuticals全资子公司Bausch Lomb宣布，FDA批准其青光眼新药VYZULTA（latanoprostene bunod滴眼液，0.024%）上市。VYZULTA是首款获批上市，可降低眼压的前列腺素类似物。
批准日期：2017年11月3日  公司：Valeant Pharmaceuticals
VYZULTA(latanoprostene bunod)眼科溶液0.024%，用于局部眼科
美国初步批准:2017年
作用机制
Latanoprostene bunod被认为通过小梁网和葡萄膜通道增加房水流出来降低眼压。眼压是青光眼进展的主要危险因素。降低眼压可降低青光眼视野丧失的风险。
适应症和用法
VYZULTA是前列腺素类似物，用于降低开角型青光眼或高眼压患者的眼压。
(1) 剂量和管理
每天晚上滴一滴在受影响的眼睛里。
剂型及强度
局部眼药水:0.24mg/mL latanoprostene bunod(0.024%)
禁忌症
没有。
警告和预防措施
•色素沉着:虹膜和眶周组织(眼睑)色素沉着增加。虹膜色素沉着可能是永久性的。
•睫毛的变化:睫毛的逐渐变化，包括睫毛的长度、厚度和数量的增加。通常在停止治疗时是可逆的。
不良反应
最常见的眼部不良反应发生率≥2%是结膜充血(6%)、眼睛刺激性(4%)、眼部疼痛(3%),和滴剂部位疼痛(2%)。
包装提供/存储和处理
VYZULTA™(latanoprostene bunod眼科解决方案),提供0.024%的低密度聚乙烯瓶滴管技巧和绿松石上限以下尺寸:
2.5mL装在4mL白色容器中- NDC 24208-504-02
5毫升灌装在7.5毫升的天然容器- NDC 24208-504-05
储存:未开封瓶应该存储冷藏2º8ºC(36º46ºF)。一旦打开一瓶可能存储在2º25ºC(36º到77ºF) 8周。
在装运期间,瓶子可能会保持在温度高达40°C (104°F)一段不超过14天。
从光保护。防止冻结。
VYZULTA(latanoprostene bunod ophthalmic solution), 0.024%
INDICATION
VYZULTA™ (latanoprostene bunod ophthalmic solution), 0.024% is indicated for the reduction of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.
IMPORTANT SAFETY INFORMATION
Increased pigmentation of the iris and periorbital tissue (eyelid) can occur. Iris pigmentation is likely to be permanent
Gradual changes to eyelashes, including increased length, increased thickness, and number of eyelashes, may occur. These changes are usually reversible upon treatment discontinuation
Use with caution in patients with a history of intraocular inflammation (iritis/uveitis). VYZULTA should generally not be used in patients with active intraocular inflammation
Macular edema, including cystoid macular edema, has been reported during treatment with prostaglandin analogs. Use with caution in aphakic patients, in pseudophakic patients with a torn posterior lens capsule, or in patients with known risk factors for macular edema
There have been reports of bacterial keratitis associated with the use of multiple-dose containers of topical ophthalmic products that were inadvertently contaminated by patients
Contact lenses should be removed prior to the administration of VYZULTA and may be reinserted 15 minutes after administration
Most common ocular adverse reactions with incidence ≥2% are conjunctival hyperemia (6%), eye irritation (4%), eye pain (3%), and instillation site pain (2%)
1）：https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=60ce7900-a677-4fc2-88d0-1603baa9dbd4
2）：http://www.bausch.com/Portals/69/-/m/BL/United%20States/USFiles/Package%20Inserts/Pharma/vyzulta-prescribing-information.pdf