Purpose

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.

Design

Prospective, randomized, double-masked, multicenter trial.

Participants

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.

Methods

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.

Main Outcome Measures

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.

Results

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.

Conclusions

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.

中文翻译：

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地塞米松前房内药物混悬液治疗白内障手术引起的炎症

目的

评估前房前腔内地塞米松药物递送悬浮液（IBI-10090; DEXYCU; Icon Bioscience Inc.，Newark，CA）的安全性和有效性，该药物可单用一次，可提供长达21天的药物治疗患者术后炎症接受白内障手术。

设计

前瞻性，随机，双掩蔽，多中心试验。

参加者

接受超声乳化单侧白内障手术的术前最佳矫正视力为20/30至20/200的患者被随机分配接受IBI-10090或安慰剂。

方法

在白内障手术结束时，将394例患者按1：2：2的比例随机分配接受5-μl安慰剂注射或5-μl342或517μgIBI-10090地塞米松药物递送混悬液注入前房。手术后对患者进行了90天的随访。

主要观察指标

主要结局是术后第8天（POD）时研究眼的前房细胞（ACC）清除（ACC评分为0）。次要结局指标是研究眼中的前房耀斑和ACC加上耀斑清除。评估了眼和非眼的不良事件。

结果

在安慰剂组中，分别在25.0％的眼中和342-μg和517-μg治疗组中的63.1％和66.0％的眼中实现了POD 8前房细胞的清除（P <0.001）。在安慰剂组中，分别有63.8％的眼睛和342-μg和517-μgIBI-10090治疗组的92.4％和89.1％的眼睛实现了POD 8的前房耀斑清除（P <0.001）。在接受安慰剂的眼睛中，分别有33.8％和342-517 g IBI-10090的眼睛中有63.1％的患者获得了前房细胞和耀斑的清除（517.6％）（P <0.001）。3组之间的不良事件相似，并且直到POD 90为止都没有严重的眼部不良事件的报道。

结论

在白内障手术后将IBI-10090地塞米松药物输送悬浮液以342和517μg的浓度放置在白内障手术前室是安全有效的，可治疗白内障手术后发生的炎症，并且可能是该患者人群中糖皮质激素滴剂的替代选择。