Department of Ophthalmology, University Hospitals UZ Leuven, Louvain, Belgium.
Research Group of Ophthalmology, Department of Neurosciences, Catholic University KU Leuven, Louvain, Belgium.
Graefes Arch Clin Exp Ophthalmol. 2024 Jan;262(1):179-190. doi: 10.1007/s00417-023-06192-0. Epub 2023 Aug 24.
PURPOSE : To compare the efficacy and safety of the fixed-dose combination (FDC) of netarsudil 0.02%/latanoprost 0.005% ophthalmic solution (NET/LAT; Roclanda) with bimatoprost 0.03%/timolol maleate 0.5% (BIM/TIM; Ganfort) ophthalmic solution in the treatment of open-angle glaucoma (OAG) and ocular hypertension (OHT).
MERCURY-3 was a 6-month prospective, double-masked, randomized, multicenter, active-controlled, parallel-group, non-inferiority study. Patients (≥ 18 years) with a diagnosis of OAG or OHT in both eyes that was insufficiently controlled with topical medication (IOP ≥ 17 mmHg in ≥ 1 eye and < 28 mmHg in both eyes) were included. Following washout, patients were randomized to once-daily NET/LAT or BIM/TIM for up to 6 months; efficacy was assessed at Week 2, Week 4, and Month 3; safety was evaluated for 6 months. Comparison of NET/LAT relative to BIM/TIM for mean IOP at 08:00, 10:00, and 16:00 h was assessed at Week 2, Week 6, and Month 3. Non-inferiority of NET/LAT to BIM/TIM was defined as a difference of ≤ 1.5 mmHg at all nine time points through Month 3 and ≤ 1.0 mmHg at five or more of nine time points through Month 3.
Overall, 430 patients were randomized (NET/LAT, n = 218; BIM/TIM, n = 212), and all received at least one dose of study medication. Efficacy analyses were performed at Month 3 on 388 patients (NET/LAT, n = 184; BIM/TIM, n = 204). NET/LAT demonstrated non-inferiority to BIM/TIM, with a between-treatment difference in IOP of ≤ 1.5 mmHg achieved at all time points and ≤ 1.0 mmHg at the majority of time points (six of nine) through Month 3. Mean diurnal IOP during the study ranged from 15.4 to 15.6 mmHg and 15.2 to 15.6 mmHg in the NET/LAT and BIM/TIM groups respectively, with no between-group statistically significant difference. No significant differences were observed in key secondary endpoints. No serious, treatment-related adverse events (AEs) were observed, and AEs were typically mild/moderate in severity. The most common treatment-related AEs were conjunctival hyperemia (NET/LAT, 30.7%; BIM/TIM, 9.0%) and cornea verticillata (NET/LAT, 11.0%; BIM/TIM, 0%).
Once-daily NET/LAT was non-inferior to BIM/TIM in IOP reduction in OAG and OHT, with AEs consistent with previous findings. NET/LAT offers a compelling alternative FDC treatment option for OAG and OHT.
比较固定剂量组合（FDC）netarsudil 0.02%/latanoprost 0.005%滴眼液（NET/LAT；Roclanda）与 bimatoprost 0.03%/timolol 马来酸盐 0.5%（BIM/TIM；Ganfort）滴眼液在治疗开角型青光眼（OAG）和眼高压（OHT）中的疗效和安全性。
MERCURY-3 是一项为期 6 个月的前瞻性、双盲、随机、多中心、活性对照、平行组、非劣效性研究。患有双眼 OAG 或 OHT（IOP 在至少 1 只眼为≥17mmHg，且双眼均<28mmHg）且局部药物治疗控制不足的患者（≥18 岁）被纳入研究。洗脱期后，患者随机接受每日一次 NET/LAT 或 BIM/TIM 治疗，最长 6 个月；在第 2 周、第 4 周和第 3 个月评估疗效；在 6 个月内评估安全性。在第 2 周、第 6 周和第 3 个月评估 NET/LAT 相对于 BIM/TIM 在 08:00、10:00 和 16:00 时的平均 IOP 比较。NET/LAT 与 BIM/TIM 的非劣效性定义为在第 3 个月的所有 9 个时间点的差值≤1.5mmHg，在第 3 个月的 5 个或更多时间点的差值≤1.0mmHg。
共有 430 名患者随机分组（NET/LAT，n=218；BIM/TIM，n=212），所有患者均至少接受了一剂研究药物。在第 3 个月对 388 名患者（NET/LAT，n=184；BIM/TIM，n=204）进行了疗效分析。NET/LAT 与 BIM/TIM 相比具有非劣效性，在所有时间点的 IOP 差值均≤1.5mmHg，在第 3 个月的大多数时间点（6/9）差值≤1.0mmHg。研究期间，日间平均 IOP 为 15.4 至 15.6mmHg，NET/LAT 和 BIM/TIM 组分别为 15.2 至 15.6mmHg，两组间无统计学显著差异。关键次要终点无显著差异。未观察到严重的、与治疗相关的不良事件（AE），AE 通常为轻度/中度。最常见的与治疗相关的 AE 是结膜充血（NET/LAT，30.7%；BIM/TIM，9.0%）和角膜卷丝状（NET/LAT，11.0%；BIM/TIM，0%）。
每日一次 NET/LAT 在降低 OAG 和 OHT 的 IOP 方面与 BIM/TIM 非劣效，AE 与既往发现一致。NET/LAT 为 OAG 和 OHT 提供了一种有吸引力的替代 FDC 治疗选择。
