Benzinga | Sep 3, 2021 07:02AM EDT

Glaukos Announces Submission of Supplemental Pre-Market Approval Application for iStent infinite

Glaukos Corporation (NYSE:GKOS), an ophthalmic medical technology and pharmaceutical company focused on novel therapies for the treatment of glaucoma, corneal disorders and retinal diseases, today announced that it has submitted a supplemental pre-market approval (PMA) application to the U.S. Food and Drug Administration (FDA) for the iStent infinite(tm)Trabecular Micro-Bypass System.

The iStent infinite is an investigational devicedesigned for use in a standalone procedure to reduce elevated intraocular pressure (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 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 is similar to the company's two-stent iStent inject(r) 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.

"This filing marks a significant achievement for Glaukos as we continue to advance our deep pipeline of novel glaucoma surgical devices and sustained pharmaceuticals," said Thomas Burns, president and chief executive officer. "Supported by strong pivotal data highlighting favorable safety and effectiveness, we believe iStent infinite may provide ophthalmic surgeons with a compelling new treatment alternative in a standalone procedure for patients with open-angle glaucoma uncontrolled by prior surgical or medical therapy."

The iStent infinite prospective, unmasked, multi-center, single-arm clinical trial enrolled subjects who had undergone prior unsuccessful incisional or cilioablative glaucoma surgery and had IOP not adequately controlled with IOP-lowering medications as well as subjects who had not undergone prior incisional or cilioablative glaucoma surgery but were on maximally tolerated IOP-lowering medications with uncontrolled IOP. In the trial, 72 subjects were implanted with the iStent infinite at 15 separate clinical sites.

Patients entered the iStent infinite IDE pivotal study with a mean baseline IOP of 23.4 mmHg on an average of 3.1 medications and an average of 2 failed prior surgeries. At 12 months, 76% of subjects achieved 20% or greater reduction in mean diurnal IOP from baseline on the same or lower ocular hypotensive medication burden. Further, more than 50% of subjects achieved Month 12 IOP reduction ? 30%. Subjects also achieved a 13% reduction in mean medication burden at 12 months. The safety profile in the study was highly favorable, with no explants, infections or device-related interventions or hypotony reported through 12 months.