Johns Hopkins University School of Medicine, 600 N. Wolfe Street, 110, Baltimore, MD, 21287, USA.
Keystone Research, Ltd, Austin, TX, USA.
Drugs. 2020 Feb;80(2):167-179. doi: 10.1007/s40265-019-01248-0.
The objective of this study was to evaluate the safety and intraocular pressure (IOP)-lowering effects over 24 months of biodegradable bimatoprost sustained-release implant (Bimatoprost SR) administration versus topical bimatoprost 0.03% in patients with open-angle glaucoma (OAG).
This was a phase I/II, prospective, 24-month, dose-ranging, paired-eye controlled clinical trial. At baseline following washout, adult patients with OAG (N = 75) received Bimatoprost SR (6, 10, 15, or 20 µg) intracamerally in the study eye; the fellow eye received topical bimatoprost 0.03% once daily. Rescue topical IOP-lowering medication or single repeat administration with implant was permitted. The primary endpoint was IOP change from baseline. Safety measures included adverse events (AEs).
At month 24, mean IOP reduction from baseline was 7.5, 7.3, 7.3, and 8.9 mmHg in eyes treated with Bimatoprost SR 6, 10, 15, and 20 µg, respectively, versus 8.2 mmHg in pooled fellow eyes; 68, 40, and 28% of pooled study eyes had not been rescued/retreated at months 6, 12, and 24, respectively. AEs in study eyes that occurred ≤ 2 days post-procedure typically were transient. After 2 days post-procedure, overall AE incidence was similar between study and fellow eyes, with some events typically associated with topical prostaglandin analogs having lower incidence in study eyes.
Bimatoprost SR showed favorable efficacy and safety profiles up to 24 months, with all evaluated dose strengths demonstrating overall IOP-reducing effects comparable to those of topical bimatoprost. Targeted and sustained delivery of bimatoprost resulted in protracted IOP lowering, suggesting that Bimatoprost SR may represent a transformational new approach to glaucoma therapy. Clinicaltrials.gov identifier: NCT01157364.
本研究旨在评估与局部使用 0.03%比马前列素相比，在开角型青光眼（OAG）患者中使用 24 个月的可生物降解贝美前列素持续释放植入物（Bimatoprost SR）的安全性和降眼压（IOP）效果。
这是一项 I/II 期、前瞻性、24 个月、剂量范围、配对眼对照临床试验。在基线洗脱后，75 例 OAG 成年患者在研究眼中接受 Bimatoprost SR（6、10、15 或 20μg）腔内给药；对侧眼接受每日一次局部使用 0.03%比马前列素。允许使用降眼压的局部补救药物或重复植入。主要终点是从基线开始的 IOP 变化。安全性措施包括不良事件（AE）。
在第 24 个月，接受 Bimatoprost SR 6、10、15 和 20μg 治疗的眼中，与 pooled 对侧眼的 8.2mmHg 相比，IOP 从基线的平均降低分别为 7.5、7.3、7.3 和 8.9mmHg；在第 6、12 和 24 个月时，pooled 研究眼中分别有 68%、40%和 28%的眼未进行补救/重复治疗。术后≤2 天发生的研究眼中的 AE 通常是短暂的。术后 2 天，研究眼和对侧眼的总体 AE 发生率相似，一些与局部前列腺素类似物相关的事件在研究眼中的发生率较低。
Bimatoprost SR 在长达 24 个月的时间内显示出良好的疗效和安全性，所有评估的剂量强度均显示出与局部使用比马前列素相当的总体降 IOP 效果。贝美前列素的靶向和持续递送导致 IOP 持续降低，表明 Bimatoprost SR 可能代表一种变革性的青光眼治疗新方法。Clinicaltrials.gov 标识符：NCT01157364。
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