Glaukos has just received FDA approval for its iStent inject Trabecular Micro-Bypass System indicated for the reduction of intraocular pressure in primary open-angle glaucoma patients undergoing concomitant cataract surgery.
The FDA approval is based on pivotal trial data showing the iStent inject achieved a statistically significant reduction in unmedicated diurnal IOP in patients undergoing cataract surgery at 24 months.
The Glaukos iStent device is just 1 millimeter in length. It is one of the smallest medical device known to be implanted into humans.