Abstract：
Purpose: To evaluate the time course of biodegradation of an intracameral, biodegradable, sustained-release bimatoprost implant that lowers intraocular pressure without the need for daily eye drops. Methods: In 2 identically designed, randomized, phase 3 clinical trials, adults with open-angle glaucoma or ocular hypertension and open iridocorneal angles inferiorly in the study eye were administered 10- or 15-μg bimatoprost implant (day 1 and weeks 16 and 32) or twice-daily topical timolol 0.5%. Implants were assessed on gonioscopy throughout the studies. Investigators reported whether implants were visible, estimated the size of visible implants relative to their initial size at implantation, and reported the implant location. Data for 10-μg implant placed on day 1 were pooled from both studies for analysis. Results: A total of 372 patients received the 10-μg bimatoprost implant. The degree of implant biodegradation at each follow-up time point was variable among patients. The implant frequently swelled during the initial phase of biodegradation from 6 to 28 weeks. Accelerated biodegradation occurred between 31 and 52 weeks, resulting in 82% of implants absent or ≤25% of initial size by 52 weeks. By month 20, 95% of implants had biodegraded to absent or ≤25% of initial size. The implant was predominantly located inferiorly in the iridocorneal angle. Conclusions: Bimatoprost implant biodegradation in phase 3 studies showed some degree of variability among patients. Clinically significant implant biodegradation was observed in the majority of patients by 12 months. Clinical studies are in progress to further understand implant biodegradation and the ideal timing for implant re-administration. ClinicalTrials.gov NCT02247804; ClinicalTrials.gov NCT02250651.
摘要：
目的：评估前房内生物降解的时间过程，可生物降解，比马前列素缓释植入物，可降低眼内压，无需每日滴眼液。方法：在2个相同设计中，随机化，3期临床试验,在研究眼中患有开角型青光眼或高眼压和开放虹膜角膜角的成年人接受了10或15μg比马前列素植入剂(第1天和第16周和第32周)或每日两次局部用噻吗洛尔0.5%.在整个研究中,在房角镜检查上评估植入物。调查人员报告了植入物是否可见，估计可见植入物的大小相对于其植入时的初始大小，并报告了植入位置。将来自两项研究的在第1天放置的10μg植入物的数据合并用于分析。结果：总共372例患者接受了10-μg比马前列素植入物。每个随访时间点的植入物生物降解程度在患者之间是可变的。植入物在6至28周的生物降解的初始阶段经常膨胀。加速生物降解发生在31至52周之间，导致82％的植入物在52周内缺失或≤25％的初始尺寸。到第20个月，95％的植入物已生物降解至初始尺寸的缺失或≤25％。植入物主要位于虹膜角膜角的下方。结论：比马前列素植入物生物降解在3期研究中显示患者之间存在一定程度的差异。到12个月时，在大多数患者中观察到临床上显着的植入物生物降解。临床研究正在进行中，以进一步了解植入物的生物降解和植入物再给药的理想时机。ClinicalTrials.govNCT02247804；ClinicalTrials.govNCT02250651。
