Glaukos Receives FDA 510(k) Clearance For iStent infinite

The U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for Glaukos’ GKOS 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 company highlighted that the iStent infinite is the first FDA-cleared micro-invasive implantable device indicated for use as a standalone treatment option for glaucoma patients not undergoing concomitant cataract surgery.

Thomas Burns, Chairman and chief executive officer, stated : “Supported by strong pivotal data highlighting favorable safety and effectiveness, we believe iStent infinite provides ophthalmic surgeons a compelling new interventional glaucoma alternative designed to provide foundational, 24/7 IOP control for their patients in need.”

Technically, 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.

The company is planning to start initial commercial launch activities for iStent infinite later this year.

FDA grants 510(k) clearance to pre-marketing application (PMA) that contains sufficient valid scientific evidence to assure that the device is safe and effective for its intended use.

Price Action : Glaukos shares are trading at $53.35 on Wednesday during after-hours session.