奈沙地尔/拉坦前列素固定剂量联合治疗开角型青光眼或高眼压。

Jake E. Radell, J. Serle
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引用次数: 5

摘要

奈沙地尔0.02%/拉坦前列素0.005%的固定剂量组合(FDC)于2019年3月12日获得美国食品和药物管理局(FDA)批准,用于降低开角型青光眼(OAG)和高眼压(OHT)患者的眼压(IOP)。奈沙地尔是一种Rho激酶(ROCK)抑制剂,拉坦前列素是前列腺素类似物(PGA)。这种FDC每天一次,通过增强小梁通路(ROCK抑制)和巩膜通路(PGA)的水流出来降低IOP。两项III期临床试验,MERCURY-1和MERCURY-2,证实了FDC比单个成分的疗效显著更高,与单独使用拉坦前列素的29-37%和单独使用奈沙地尔的21-29%相比,使用FDC的59-65%的受试者IOP降低30%或更高。FDC耐受性良好,眼部副作用轻微,全身副作用有限。本文将回顾导致FDA批准的工作和使用该组合的临床适应症。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Netarsudil/latanoprost fixed-dose combination for the treatment of open-angle glaucoma or ocular hypertension.
The fixed-dose combination (FDC) of netarsudil 0.02%/ latanoprost 0.005% was approved by the United States Food and Drug Administration (FDA) on March 12, 2019, for the reduction of intraocular pressure (IOP) in patients with open-angle glaucoma (OAG) and ocular hypertension (OHT). Netarsudil is a Rho kinase (ROCK) inhibitor and latanoprost is a prostaglandin analogue (PGA). Once-daily administration of this FDC reduces IOP by enhancing aqueous outflow through both the trabecular pathways (ROCK inhibition) and uveoscleral pathways (PGA). Two phase III clinical trials, MERCURY-1 and MERCURY-2, confirmed significantly greater efficacy of the FDC than the individual components, with IOP reductions of 30% or greater observed in 59-65% of subjects treated with FDC compared with 29-37% of subjects treated with latanoprost alone and 21-29% of subjects treated with netarsudil alone. The FDC was well tolerated with mostly mild ocular side effects and limited systemic side effects. This paper will review the work leading to FDA approval and the clinical indications for the use of this combination.
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