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.
iStent is not only the smallest medical implant known to be implanted in the human body, it also started a revolution in glaucoma surgery and treatment as the first Micro-Invasive Glaucoma Surgery device. The first MIGS device approved by the FDA, iStent has been implanted in over 300,000 eyes around the world.
Glaukos says it plans to begin initial commercial launch activities for the iStent inject later this fall.