IBI-10090 dexamethasone drug-delivery suspension safe, effective for postoperative inflammation
An anterior chamber intracameral dexamethasone drug-delivery suspension (IBI-10090) at concentrations of 342 and 517 μg is safe and effective in treating postoperative inflammation in patients undergoing cataract surgery, according to a study. In addition, IBI-10090 may replace corticosteroid drop installation in these patients.
A total of 394 patients undergoing unilateral cataract surgery by phacoemulsification were randomized 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. All patients were followed for 90 days after surgery.
Anterior chamber cell (ACC) clearing (ACC score of 0) in the study eye at postoperative day (POD) 8 was the primary outcome. Secondary outcomes were anterior chamber flare and ACC plus flare clearing in the study eye. The investigators also assessed ocular and nonocular adverse events.
More eyes in the 342- and 517-μg IBI-10090 treatment groups (63.1 percent and 66.0 percent, respectively) vs the placebo group (25.0 percent) achieved ACC clearing at POD 8 (p<0.001). Likewise, more eyes in the 342- and 517-μg treatment groups (92.4 percent and 89.1 percent, respectively) vs the placebo group (63.8 percent) achieved anterior chamber flare clearing at POD 8 (p<0.001).
Moreover, anterior chamber cell plus flare clearing at POD 8 was achieved in 63.1 percent and 67.3 percent of eyes receiving 342- and 517-μg IBI-10090, respectively, and in 33.8 percent of eyes receiving placebo (p<0.001).
Adverse events were comparable among the three groups, and there were no reports of serious ocular adverse events up to POD 90.