Garcia Giancarlo A, Ngai Philip, Mosaed Sameh, Lin Ken Y
Department of Ophthalmology, Gavin Herbert Eye Institute, University of California, Irvine, Irvine, CA, USA.
Clin Ophthalmol. 2016 Oct 18;10:2035-2050. doi: 10.2147/OPTH.S103985. eCollection 2016.
Latanoprostene bunod (LBN) is a novel nitric oxide-donating prostaglandin F receptor agonist in clinical development for intraocular pressure lowering in open-angle glaucoma and ocular hypertension. Currently in Phase III clinical trials in the USA, European Union, and Japan, LBN has demonstrated promising efficacy while maintaining safety and tolerability. We review preclinical and clinical developmental efforts and evaluate the potential role of LBN monotherapy in the management of open-angle glaucoma and ocular hypertension. The current LBN clinical development program comprises eight trials, four of which have resulted in publication of complete methodology and outcomes. We additionally pool adverse events data to determine incidences across three pivotal studies. Evidence thus far indicates that LBN may be a safe and effective ocular hypotensive agent, although the potential neuroprotective effects and the impact on visual field loss remain to be evaluated.
比马前列素氮氧化物(LBN)是一种新型的一氧化氮供体型前列腺素F受体激动剂,正处于临床开发阶段,用于降低开角型青光眼和高眼压症患者的眼压。目前,LBN正在美国、欧盟和日本进行III期临床试验,已显示出有前景的疗效,同时保持了安全性和耐受性。我们回顾了临床前和临床开发工作,并评估了LBN单药治疗在开角型青光眼和高眼压症管理中的潜在作用。当前的LBN临床开发项目包括八项试验,其中四项试验的完整方法和结果已发表。我们还汇总了不良事件数据,以确定三项关键研究中的发生率。迄今为止的证据表明,LBN可能是一种安全有效的降眼压药物,尽管其潜在的神经保护作用以及对视野缺损的影响仍有待评估。