Evaluate the safety and intraocular pressure (IOP)-lowering efficacy of two models of the travoprost intraocular implant (fast-eluting [FE-implant] and slow eluting [SE-implant]) from one of two pivotal trials (GC-010). Phase 3, multicenter, randomized, double-masked, sham-controlled, non-inferiority trial. Subjects with open-angle glaucoma or ocular hypertension, using 0 to 3 IOP-lowering medications at screening and having an unmedicated baseline mean diurnal IOP (average of 8AM, 10AM and 4PM timepoints) of ≥ 21 mmHg, and an unmedicated baseline IOP of ≤ 36 mmHg at each timepoint in the study eye. Study eyes were randomized to the travoprost intraocular implant (FE-implant [n=200] or SE-implant [n=197] model) plus twice-daily (BID) placebo eye drops, or to sham procedure plus timolol ophthalmic solution, 0.5% BID (n=193). The primary outcome was mean change from baseline IOP in the study eye at 8AM and 10AM, at each of day 10, week 6, and month 3. Safety outcomes included adverse events (AEs), corneal endothelial cell counts, visual acuity, and conjunctival hyperemia assessment. Mean IOP reduction from baseline over the 6 timepoints ranged from 6.6 to 8.4 mmHg for the FE-implant group, from 6.6 to 8.5 mmHg for the SE-implant group, and from 6.5 to 7.7 mmHg for the timolol group. The primary efficacy endpoint was met; the upper limit of the 95% confidence interval of the difference between the implant groups and the timolol group was < 1 mmHg at all 6 timepoints. Study eye AEs, most of mild or moderate severity, were reported in 21.5%, 27.2% and 10.8% of subjects in the FE-implant, SE-implant and timolol groups, respectively. The most common AEs included iritis (FE-implant, 0.5%; SE-implant, 5.1%), ocular hyperaemia (FE-implant, 3.0%; SE-implant, 2.6%), visual acuity reduced (FE-implant, 1.0%; SE-implant, 4.1%; timolol, 0.5%), and IOP increased (FE-implant, 3.5%; SE-implant, 2.6%; timolol, 2.1%). There was one serious study eye AE (endophthalmitis). The travoprost intraocular implant demonstrated robust IOP reduction over the 3-month primary efficacy evaluation period following a single administration. The IOP-lowering efficacy of both implant groups was statistically and clinically non-inferior to the timolol group, with a favorable safety profile.

中文翻译：

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曲伏前列素眼内植入物治疗开角型青光眼或高眼压症患者安全性和有效性的 3 期随机临床试验

根据两项关键试验 (GC-010) 之一评估两种曲伏前列素眼内植入物模型（快速洗脱 [FE 植入物] 和慢速洗脱 [SE 植入物]）的安全性和降低眼压 (IOP) 的功效。3 期、多中心、随机、双盲、假对照、非劣效性试验。患有开角型青光眼或高眼压症的受试者，在筛查时使用 0 至 3 种降低 IOP 的药物，且未经药物治疗的基线每日平均 IOP（上午 8 点、上午 10 点和下午 4 点时间点的平均值）≥ 21 mmHg，且未经药物治疗的基线 IOP ≤研究眼每个时间点的压力为 36 mmHg。研究眼睛被随机分配至曲伏前列素眼内植入物（FE 植入物 [n=200] 或 SE 植入物 [n=197] 模型）加每日两次 (BID) 安慰剂滴眼液，或假手术加噻吗洛尔眼用溶液，0.5 % 出价 (n=193)。主要结局是研究眼睛在第 10 天、第 6 周和第 3 个月每天上午 8 点和上午 10 点相对于基线 IOP 的平均变化。安全性结局包括不良事件 (AE)、角膜内皮细胞计数、视力和结膜。充血评估。FE 植入组在 6 个时间点相对于基线的平均 IOP 降低范围为 6.6 至 8.4 mmHg，SE 植入组为 6.6 至 8.5 mmHg，噻吗洛尔组为 6.5 至 7.7 mmHg。达到主要疗效终点；植入物组和噻吗洛尔组之间差异的 95% 置信区间上限在所有 6 个时间点均 < 1 mmHg。FE 植入物组、SE 植入物组和噻吗洛尔组中分别有 21.5%、27.2% 和 10.8% 的受试者报告了研究眼部 AE，大多数为轻度或中度严重程度。最常见的 AE 包括虹膜炎（FE 植入物，0.5%；SE 植入物，5.1%）、眼部充血（FE 植入物，3.0%；SE 植入物，2.6%）、视力下降（FE 植入物，1.0%） ；SE-植入物，4.1%；噻吗洛尔，0.5%），眼压增加（FE-植入物，3.5%；SE-植入物，2.6%；噻吗洛尔，2.1%）。研究中出现了一项严重的眼部 AE（眼内炎）。曲伏前列素眼内植入物在单次给药后的 3 个月主要疗效评估期内显示出强劲的眼压降低效果。两个植入物组的降眼压功效在统计学和临床​​上均不劣于噻吗洛尔组，并且具有良好的安全性。