Glaukos announced that it has submitted a supplemental pre-market approval (PMA) application to the FDA for the iStent infinite Trabecular Micro-Bypass System. The iStent infinite is an investigational device designed for use in a standalone procedure to reduce elevated IOP in patients with open-angle glaucoma uncontrolled by prior surgical or medical therapy. It 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 6 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 is similar 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.