■ Glaukos Corporation announced it has received 510(k) clearance for the iStent infinite trabecular microbypass system indicated for use in a standalone procedure to reduce elevated IOP in patients with primary open-angle glaucoma (POAG) uncontrolled by prior therapy. The iStent infinite comprises 3 heparin-coated titanium stents preloaded into an autoinjection system that allows the surgeon to inject stents across approximately 6 clock hours of Schlemm's canal, according to the company. The stents lower IOP by restoring the natural, physiologic outflow of aqueous humor. The mechanism of action is similar to the company’s 2-stent iStent inject W trabecular microbypass system, FDA approved for the reduction of IOP in adult mild-to-moderate POAG patients undergoing concomitant cataract surgery.

“This FDA clearance represents a significant milestone as iStent infinite is the first microinvasive implantable device indicated for use as a standalone treatment option,” said Thomas Burns, chairman and CEO, in a news release. “We believe iStent infinite provides ophthalmic surgeons a compelling new interventional glaucoma alternative designed to provide foundational, 24/7 IOP control.”

The company intends to commence initial commercial launch activities for iStent infinite in late 2022.