Simbrinza悬液获准用于治疗青光眼

圣路易斯(MD Consult)——2013年4月19日，Alcon宣布美国食品药品管理局(FDA)已批准Simbrinza悬液上市，适用于降低原发性开角型青光眼或高眼压症患者的高眼压。Simbrinza是一种固定剂量复方制剂，包含一种碳酸酐酶抑制剂(布林佐胺1.0%)和一种α2肾上腺素能受体激动剂(酒石酸溴莫尼定0.2%)。用法为患眼每次1滴，每日3次。

FDA批准Simbrinza是基于2项关键3期临床试验的数据。这2项研究共招募了大约1,300例患者，评估了布林佐胺1.0%与溴莫尼定0.2%固定剂量复方制剂每日给药3次的安全性与有效性，并与仅给予其中一种成分进行了比较。这2项研究均达到了其主要终点，证明在3个月内所有时间点的平均眼压方面，Simbrinza相对于单一成分具有统计学优势。在这2项研究中，Simbrinza组患者的3个月时眼压比基线时(22~36 mmHg)下降了5~9 mmHg。

在这2项为期3个月的临床试验中，接受Simbrinza治疗的患者最常报告的不良反应为视力模糊、眼刺激、味觉障碍、口干和眼过敏。Simbrinza组患者有11%停药，主要原因是不能耐受不良反应。Simbrinza的安全性特征与其所含的2种活性成分一致。此外，在接受Simbrinza治疗的患者中未发生明显的心血管或肺部事件。

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ST LOUIS (MD Consult) - On April 19, 2013, Alcon announced that the US Food and Drug Administration (FDA) has approved Simbrinza suspension, indicated for the reduction of elevated intraocular pressure (IOP) in patients with primary open-angle glaucoma or ocular hypertension. Simbrinza is a fixed-dose combination of a carbonic anhydrase inhibitor (brinzolamide 1.0%) and an alpha-2 adrenergic receptor agonist (brimonidine tartrate 0.2%). The dose for Simbrinza is 1 drop instilled into the affected eye(s) 3 times daily.

The FDA approval of Simbrinza was granted on the basis of data from 2 pivotal phase 3 clinical trials that included approximately 1,300 patients. The studies evaluated the safety and efficacy of a fixed-dose combination of brinzolamide 1.0% and brimonidine 0.2%, administered 3 times daily, compared with separate 3-times-daily dosing of one or the other component. Both studies met their primary end point and demonstrated that Simbrinza was statistically superior compared with either component regarding mean IOP at month 3 for all time points. In both studies, Simbrinza achieved a 5- to 9-mm Hg reduction from baseline to month 3. Participants' mean IOP at baseline was 22- to 36-mm Hg.

In both 3-month clinical trials, the most frequently reported adverse reactions in patients treated with Simbrinza were blurred vision, eye irritation, dysgeusia, dry mouth, and eye allergy. Treatment discontinuation mainly attributed to adverse reaction was reported in 11% of Simbrinza-treated patients. The safety profile of Simbrinza was comparable with each of the individual components. Additionally, no significant cardiovascular or pulmonary events occurred in Simbrinza-treated patients in either study.

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