Glaukos Corporation announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the iStent infinite® Trabecular Micro-Bypass System indicated for use in a standalone procedure to reduce elevated intraocular pressure (IOP) in patients with primary open-angle glaucoma uncontrolled by prior medical and surgical therapy. The iStent infinite includes three heparin-coated titanium stents preloaded into an auto-injection system that allows the surgeon to inject stents across a span of up to approximately six clock hours around Schlemm's canal, the eye's primary drainage channel. Once in place, the stents are designed to lower IOP by restoring the natural, physiological outflow of aqueous humor.

The iStent infinite has a similar mechanism of action to the company's two-stent iStent inject® W Trabecular Micro-Bypass System, which is approved by the FDA for the reduction of IOP in adult mild-to-moderate primary open-angle glaucoma patients undergoing concomitant cataract surgery.