近日，FDA批准其青光眼新药VYZULTA（latanoprostene 中文译名：拉坦前列素酸滴眼液，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。 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。通过现有的药物或手术疗法来降低眼压，能减缓疾病发展，降低致盲的风险。 VYZULTA是一款每日一次的单药疗法，在青光眼的治疗上有着双重作用机制——拉坦前列素酸（latanoprost acid）能作用于葡萄膜巩膜通路，促进房水的排出；丁二醇单硝酸酯（butanediol mononitrate）则能释放一氧化氮，通过小梁网和许莱姆氏管（Schlemm's canal），促进房水排出。这种双管齐下的疗法在一系列临床试验中得到了验证：与马来酸噻吗洛尔滴眼液相比，VYZULTA展现出了非劣效与优效；与拉坦前列素相比，VYZULTA能更显着地降低眼压。 批准日期：2017年11月15日 公司：Valeant制药 VYZULTA TM（拉坦前列酮[latanoprostene bunod ophthalmic solution]）眼用溶液 0.024％ 适应症 VYZULTA™（拉坦前列酮bunod眼科溶液 0.024％）用于降低开角型青光眼或高眼压症患者的眼内压（IOP）。 剂量和给药 推荐的剂量是在傍晚每天一次受影响的眼睛的结膜囊中的一滴。由于已经表明更频繁地施用前列腺素类似物可以降低眼内压降低效果，因此不要使用VYZULTA TM（拉坦前列酮bunod眼用溶液），每天多于0.024％。 如果VYZULTA与其他局部用眼科药品同时使用以降低眼内压，则应分开给药每种药品至少五（5）分钟。 如何提供 剂型和强度 VYZULTA是一种局部眼用溶液，含有0.24 mg / mL的拉坦前列酮。 存储和处理 VYZULTA™（拉坦前列腺素眼用溶液），0.024％以天然低密度聚乙烯，7.5mL带滴头的瓶子和一个装满5mL填充体积的绿松石瓶盖（NDC 24208-504-05）提供。 存储 未开封的瓶子应该在2°至8°C（36°至46°F）的温度下冷藏。一旦打开瓶子，可将其储存在2°至25°C（36°至77°F）的环境中8周。 VYZULTA™ (latanoprostene bunod ophthalmic solution), 0.024% 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%)