Glaukos, based in San Clemente, California, won FDA approval to introduce its iStent inject Trabecular Micro-Bypass System in the United States. The device, designed to treat mild to moderate primary open-angle glaucoma, is implanted alongside cataract surgeries to reduce intraocular pressure.
The implant is tiny, measuring only 0.23 mm x 0.36 mm, and Glaukos believes it is the smallest device ever approved by the FDA. It’s positioned to allow for fluid to move through the trabecular meshwork, producing flow in both direction within the Schlemm’s canal.
Some details about the study that led to the approval, according to Glaukos:
The FDA approval is based on the iStent inject U.S. IDE pivotal study, a prospective, randomized, multicenter clinical trial that included 41 investigational sites and 505 mild-to-moderate POAG eyes that were randomized to receive iStent inject in combination with cataract surgery (n=387) or cataract surgery only (n=118.) The pivotal trial data show 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. In addition to meeting the study’s primary and secondary effectiveness endpoints, at 24 months, observed data show that the iStent inject cohort achieved a 31% mean reduction, or 7.7 mmHg, in unmedicated IOP from an unmedicated mean baseline IOP of 24.8 mmHg to 17.1 mmHg. Finally, through 24 months, the overall rate of adverse events for the iStent inject cohort was similar to cataract surgery alone.
Here’s an animation demonstrating how the iStent inject is implanted and how it works:
Product page: iStent inject…