Ophthalmic Consultants of Long Island, Garden City, New York, and Department of Ophthalmology, New York University, New York, New York.
Cornea Services, Cincinnati Eye Institute, Department of Ophthalmology, University of Cincinnati, Cincinnati, Ohio.
Ophthalmology. 2018 Jun;125(6):799-806. doi: 10.1016/j.ophtha.2017.12.029. Epub 2018 Feb 13.
To evaluate the safety and efficacy of an anterior chamber intracameral dexamethasone drug-delivery suspension (IBI-10090; DEXYCU; Icon Bioscience Inc., Newark, CA) that provides medication for up to 21 days with a single application in treating postoperative inflammation in patients undergoing cataract surgery.
Prospective, randomized, double-masked, multicenter trial.
Patients with preoperative best-corrected visual acuity of 20/30 to 20/200 undergoing unilateral cataract surgery by phacoemulsification were randomized to receive IBI-10090 or placebo.
Three hundred ninety-four patients were randomized 1:2:2 to receive 5-μl injections of placebo or 5-μl injections of 342 or 517 μg IBI-10090 dexamethasone drug delivery suspension injected into the anterior chamber at the conclusion of cataract surgery. Patients were followed for 90 days after surgery.
Primary outcome was anterior chamber cell (ACC) clearing (ACC score of 0) in the study eye at postoperative day (POD) 8. Secondary outcome measures were anterior chamber flare and ACC plus flare clearing in the study eye. Ocular and nonocular adverse events were assessed.
Anterior chamber cell clearing at POD 8 was achieved in 25.0% of eyes in the placebo group and in 63.1% and 66.0% of eyes in the 342- and 517-μg treatment groups, respectively (P < 0.001). Anterior chamber flare clearing at POD 8 was achieved by 63.8% of eyes in the placebo group and in 92.4% and 89.1% of eyes in the 342- and 517-μg IBI-10090 treatment groups, respectively (P < 0.001). Anterior chamber cell plus flare clearing at POD 8 was achieved in 33.8% of eyes receiving placebo and in 63.1% and 67.3% of eyes receiving 342- and 517-μg IBI-10090, respectively (P < 0.001). Adverse events among the 3 groups were similar, and no serious ocular adverse events were reported up to POD 90.
The IBI-10090 dexamethasone drug-delivery suspension placed in the anterior chamber after cataract surgery at concentrations of 342 and 517 μg was safe and effective in treating inflammation occurring after cataract surgery and may be an alternative to corticosteroid drop installation in this patient population.
评估前房内曲安奈德药物输送悬浮液（IBI-10090；DEXYCU；Icon Bioscience Inc.，加利福尼亚州纽瓦克）的安全性和疗效，该药物在白内障手术后可提供长达 21 天的药物治疗，单次应用即可。
前瞻性、随机、双盲、多中心试验。
接受超声乳化白内障吸除术的单侧白内障患者，术前最佳矫正视力为 20/30 至 20/200，随机分为接受 IBI-10090 或安慰剂治疗。
394 名患者按 1:2:2 的比例随机接受 5μl 安慰剂或 5μl 342μg 或 517μg IBI-10090 曲安奈德药物输送悬浮液注射到白内障手术后前房。患者在手术后 90 天内接受随访。
主要结局是术后第 8 天研究眼的前房细胞（ACC）清除（ACC 评分 0）。次要观察指标为研究眼的前房闪光和 ACC 加闪光清除。评估眼部和非眼部不良事件。
安慰剂组研究眼在术后第 8 天达到前房细胞清除的比例为 25.0%，342μg 和 517μg 治疗组分别为 63.1%和 66.0%（P<0.001）。安慰剂组研究眼在术后第 8 天达到前房闪光清除的比例为 63.8%，342μg 和 517μg IBI-10090 治疗组分别为 92.4%和 89.1%（P<0.001）。安慰剂组研究眼在术后第 8 天达到前房细胞加闪光清除的比例为 33.8%，342μg 和 517μg IBI-10090 治疗组分别为 63.1%和 67.3%（P<0.001）。3 组间不良反应相似，至第 90 天未报告严重眼部不良事件。
在白内障手术后前房内放置浓度为 342μg 和 517μg 的 IBI-10090 曲安奈德药物输送悬浮液是安全有效的，可用于治疗白内障手术后发生的炎症，可能是该患者人群中皮质类固醇滴眼剂治疗的替代方法。
