To compare intraocular pressure (IOP)-lowering efficacy and safety of NCX 470, a nitric oxide (NO)-donating bimatoprost, to latanoprost in subjects with open-angle glaucoma (OAG) or ocular hypertension (OHT). Prospective, phase 3, randomized, adaptive dose-selection, double-masked, parallel-group trial. 691 subjects with OAG or OHT and unmedicated IOP ≥26 mmHg at 8AM, ≥24 mmHg at 10AM, and ≥22 mmHg at 4PM in the study eye were randomized to NCX 470 0.065%, NCX 470 0.1%, or latanoprost 0.005%. An interim analysis was performed to select the final dose of NCX 470. We evaluated noninferiority of NCX 470 versus latanoprost, based on IOP reduction from baseline at 8AM and 4PM at 2 weeks, 6 weeks, and 3 months. 661 subjects were analyzed; IOP was significantly reduced at all on-treatment time points, with reductions ranging from 8.0 to 9.7 mmHg ( < .0001 at each time point) in the NCX 470 0.1% group. Mean IOP reductions were greater with NCX 470 0.1% than latanoprost 0.005% at all 6 time points and significantly greater ( < .05) at 4 of the 6 time points. The most common adverse event was conjunctival/ocular hyperemia. The NO-donating prostaglandin analogue NCX 470 0.1% was well-tolerated and lowered IOP more than latanoprost in subjects with OAG or OHT at all 6 time points. With a dual mechanism of action that enhances both uveoscleral and trabecular outflow, NCX 470 could become an important first-line therapy for IOP reduction in glaucoma.

中文翻译：

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NCX 470（一种提供一氧化氮的比马前列素）和拉坦前列素在开角型青光眼或高眼压患者中的随机对照比较：MONT BLANC 研究

比较NCX 470（一种提供一氧化氮（NO）的比马前列素）与拉坦前列素在开角型青光眼（OAG）或高眼压症（OHT）受试者中的降低眼压（IOP）的功效和安全性。前瞻性、3 期、随机、适应性剂量选择、双盲、平行组试验。 691 名患有 OAG 或 OHT 且研究眼中未用药 IOP ≥26 mmHg（上午 8 点）、≥24 mmHg（上午 10 点）和 ≥22 mmHg（下午 4 点）的受试者被随机分配至 NCX 470 0.065%、NCX 470 0.1% 或拉坦前列素 0.005%。我们进行了中期分析来选择 NCX 470 的最终剂量。我们根据第 2 周、第 6 周和第 3 个月上午 8 点和下午 4 点相对于基线的 IOP 降低情况，评估了 NCX 470 相对于拉坦前列素的非劣效性。分析了 661 名受试者；在所有治疗时间点，IOP 均显着降低，NCX 470 0.1% 组的降低范围为 8.0 至 9.7 mmHg（每个时间点 < .0001）。在所有 6 个时间点，NCX 470 的平均 IOP 降低幅度为 0.1%，大于拉坦前列素的 0.005%，并且在 6 个时间点中的 4 个时间点显着降低 (< .05)。最常见的不良事件是结膜/眼充血。在所有 6 个时间点患有 OAG 或 OHT 的受试者中，NO 供体前列腺素类似物 NCX 470 0.1% 具有良好的耐受性，并且比拉坦前列素更能降低 IOP。 NCX 470 具有增强葡萄膜巩膜和小梁流出的双重作用机制，可能成为降低青光眼眼压的重要一线疗法。