近日，美国FDA批准青光眼新药VYZULTA（latanoprostene bunod 滴眼液 0.024%）上市。这也是首款获批上市，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。
此次，获批的VYZULTA是一款每日一次的单一药物疗法。该药物的有效成分拉坦前列素酸（latanoprost acid）和丁二醇单硝酸酯（butanediol mononitrate），在青光眼的治疗上有着双重作用机制——既能作用于葡萄膜巩膜通路，又能通过释放一氧化氮作用于小梁网和许莱姆氏管（Schlemm's canal），促进房水排出。这种双管齐下疗法的疗效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性；与拉坦前列素相比，VYZULTA能更显著地降低眼压。此外，它的短期疗效与长期安全性也得到了证实。

Vyzulta (Latanoprostene Bunod Ophthalmic Solution)
VYZULTA Rx
Generic Name and Formulations:
Latanoprostene bunod 0.024%; oph soln; contains benzalkonium chloride.
Company:
Valeant Pharmaceuticals, Inc
Indications for VYZULTA:
Open-angle glaucoma. Ocular hypertension.
Adult:
>16yrs: 1 drop once daily in the PM.
Children:
≤16yrs: not recommended.
Warnings/Precautions:
Do not exceed recommended dose (may reduce efficacy). History of ocular inflammation: not recommended if active inflammation. Aphakia. Pseudophakia with torn posterior lens capsule. Risk of macular edema. Bacterial keratitis may occur (due to multiple-dose containers). Contact lenses (remove; may reinsert lenses 15mins after administration). Pregnancy. Nursing mothers.
Interactions:
Allow at least 5mins between application of other topical oph agents.
Pharmacological Class:
Prostaglandin analogue.
Adverse Reactions:
Conjunctival hyperemia, eye irritation, eye pain, instillation site pain; increased ocular pigmentation (eg, iris [may be permanent], eyelid, eyelashes), other eyelash/lid changes, macular edema (including cystoid macular edema).
Generic Availability:
NO
How Supplied:
Soln—5mL