■ Glaukos has received premarket approval from the FDA for its next-generation iStent inject Trabecular Micro-Bypass System indicated for the reduction of IOP in adult mild-to-moderate primary open-angle glaucoma (POAG) patients undergoing concomitant cataract surgery. According to the company, the iStent inject is the smallest medical device ever approved by the FDA.
The iStent inject is designed to optimize the natural physiological outflow of aqueous humor by creating two bypasses through the trabecular meshwork, the main source of resistance in glaucomatous eyes, resulting in multi-directional flow through Schlemm’s canal. It includes two heparin-coated titanium stents preloaded into an auto-injection system that allows the surgeon to precisely implant stents into two trabecular meshwork locations through a single corneal entry point in a straightforward click-and-release motion. The iStent inject is based on the same fluidic method of action as the company’s first-generation pioneering iStent, which has been implanted in more than 400,000 eyes worldwide since its introduction in 2012.
The FDA approval is based on the iStent inject US IDE pivotal study, a prospective, randomized, multicenter clinical trial of 505 POAG patients randomized to receive iStent inject in combination with cataract surgery (n=387) or cataract surgery only (n=118). The trial data showed that the iStent inject achieved a statistically significant reduction in unmedicated diurnal IOP in patients undergoing cataract surgery at 24 months, as 75.8% of the iStent inject cohort achieved a 20% or greater reduction in unmedicated IOP and the mean unmedicated IOP reduction was 7.0 mmHg for the iStent inject cohort.