Sustained-release steroid injection for postop inflammation shows promise

A new way to deliver dexamethasone to reduce inflammation after cataract surgery was shown effective in a phase 3 clinical trial.

IBI-10090 uses Icon Bioscience’s Verisome system to dispense an extended-release formulation of dexamethasone through a single injection into the anterior chamber immediately after cataract surgery.

“This is a novel therapeutic designed to improve the management of post-surgery inflammation,” said David S. Tierney, MD, president and CEO of Icon. “IBI-10090 has been developed to increase efficacy by placing the drug at the site of action and to help patients, in a largely elderly population, avoid noncompliance and dosing errors associated with the comparatively burdensome process of multiple, self-administered, daily eye drops.”

The prospective, randomized, double-masked, placebo-controlled, multicenter clinical trial included 394 patients undergoing unilateral phacoemulsification with posterior chamber intraocular lens implantation. They received placebo or IBI-10090 342 µg or 517 µg placed into the anterior chamber at the end of surgery.

At day 8, significantly more patients in each of the treatment groups had anterior chamber cell clearing than those in the placebo group, achieving the study’s primary endpoint. Additionally, significantly more treated patients achieved anterior chamber flair clearing at day 8 and anterior chamber cell and flare clearing at day 8 compared with those who received placebo.

The subjects were followed for 90 days, with no ocular serious adverse events reported and adverse events similar among the three groups.