<br>曲伏前列素眼内植入物在减少开角型青光眼或高眼压患者局部降眼压药物负担方面的功效和安全性,Drugs

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曲伏前列素眼内植入物在减少开角型青光眼或高眼压患者局部降眼压药物负担方面的功效和安全性
Drugs ( IF 13.0 ) Pub Date : 2023-12-07 , DOI: 10.1007/s40265-023-01973-7
John P Berdahl ₁ , Steven R Sarkisian ₂ , Robert E Ang ₃ , Long V Doan ₄ , Angela C Kothe ₄ , Dale W Usner ₄ , L Jay Katz _{4,

5,

6} , Tomas Navratil ₄ ,

Affiliation

目的

一项随机、双盲、多中心、2 期试验，旨在评估曲伏前列素眼内植入物的长期安全性和有效性，曲伏前列素是一种缓释药物输送系统，旨在提供不间断的持续眼内压 (IOP) 降低治疗，从而减少患者的眼压治疗负担并提高降眼压药物的依从性。

方法

开角型青光眼或高眼压患者接受快速洗脱植入物（FE 植入物， n = 51）并接受每日两次（BID）安慰剂滴眼液，缓慢洗脱（SE 植入物， n = 54）并接受BID 安慰剂滴眼液，或接受假手术并接受 BID 0.5% 噻吗洛尔 ( n = 49)。在基线、第 1-2 天、第 10 天、第 4 周、第 6 周、第 3 个月以及此后每 3 个月测量一次 IOP，直至 36 个月。通过从上午 8:00 未用药基线 IOP 到第 36 个月的平均变化以及筛选时（研究前）接受相同或更少的局部降眼压药物的患者百分比来评估疗效。通过不良事件和眼科参数评估安全性。

结果

与 BID 噻吗洛尔相比，单次施用曲伏前列素植入物后第 36 个月观察到临床和统计学相关的 IOP 降低治疗效果，FE 植入物组平均 IOP 降低范围为 7.6 至 8.8 mmHg，SE 为 7.3 至 8.0 mmHg植入组在上午 8:00 时间点从 7.3 降至 7.9（所有治疗组在所有就诊时P < 0.0001）。在第 12、24 和 36 个月时，与噻吗洛尔患者相比，使用相同或更少的局部降眼压药物得到良好控制的 FE 和 SE 植入患者比例更高，而筛查时 FE 和 SE 植入组的比例为 63% 和 69%。第 36 个月时，噻吗洛尔组分别为 45%。植入物的安全性良好；没有移位，没有外植，没有结膜充血或眶周脂肪萎缩的不良事件，没有因研究眼不良事件而中断，也没有研究眼发生任何严重不良事件。在 36 个月内，三个治疗组观察到角膜内皮细胞计数相对于基线的可比变化。

结论

曲伏前列素眼内植入物表现出强大的降眼压作用，并在单次给药后长达 36 个月内显着减少局部降眼压药物负担，同时保持良好的安全性。曲伏前列素眼内植入物有望成为介入性青光眼治疗方案的一个有意义的补充，它解决了局部降眼压药物的主要缺点，包括依从性低和局部副作用，同时控制眼压长达 36 个月。

试验登记处

ClinicalTrials.gov 标识符 NCT02754596 于 2016 年 4 月 28 日注册。

"点击查看英文标题和摘要"

Efficacy and Safety of the Travoprost Intraocular Implant in Reducing Topical IOP-Lowering Medication Burden in Patients with Open-Angle Glaucoma or Ocular Hypertension

Purpose

A randomized, double-masked, multicenter, phase 2 trial to evaluate the long-term safety and efficacy of travoprost intraocular implant, an extended-release drug delivery system designed to provide uninterrupted sustained intraocular pressure (IOP)-lowering therapy, thereby reducing patient treatment burden and improving adherence with IOP-lowering medication.

Methods

Patients with open-angle glaucoma or ocular hypertension were administered a fast-eluting implant (FE implant, n = 51) and received twice-daily (BID) placebo eye drops, a slow-eluting (SE implant, n = 54) and received BID placebo eye drops, or underwent a sham surgical procedure and received BID timolol 0.5% (n = 49). IOP was measured at baseline, day 1–2, day 10, week 4, week 6, month 3, and every 3 months thereafter through 36 months. Efficacy was evaluated by mean change from 8:00 AM unmedicated baseline IOP through month 36, and the percentage of patients receiving the same or fewer topical IOP-lowering medications as at screening (pre-study). Safety was evaluated by adverse events and ophthalmic parameters.

Results

Clinically and statistically relevant IOP-lowering treatment effects were observed through month 36 after a single administration of the travoprost implant compared with BID timolol with mean IOP reductions ranging from 7.6 to 8.8 mmHg for the FE implant group, from 7.3 to 8.0 mmHg for the SE implant group, and from 7.3 to 7.9 for the timolol group at the 8:00 AM timepoint (P < 0.0001 for all treatment groups at all visits). At months 12, 24, and 36, a greater percentage of FE and SE implant patients versus timolol patients were well controlled on the same or fewer topical IOP-lowering medications compared with screening with 63 and 69% for the FE and SE implants groups, respectively, versus 45% for the timolol group at month 36. The safety profile of the implant was favorable; there were no dislodgements, no explantations, no adverse events of conjunctival hyperemia or periorbital fat atrophy, no discontinuations due to study eye adverse events, nor any serious adverse events in the study eye. Comparable changes from baseline in corneal endothelial cell counts were observed in the three treatment groups over the 36 months.

Conclusion

The travoprost intraocular implant demonstrated robust IOP-lowering and substantially reduced topical IOP-lowering medication burden for up to 36 months following a single administration, while maintaining a favorable safety profile. The travoprost intraocular implant promises to be a meaningful addition to the interventional glaucoma armamentarium by addressing the key shortcomings of topical IOP-lowering medications, including low adherence and topical side effects while controlling IOP for up to 36 months.