Benzinga | Sep 3, 2021 09:45AM EDT

Glaukos Files Pre-Market Application For Intraocular Pressure Device

* Glaukos Corp (NYSE:GKOS) has submitted a supplemental premarket approval (PMA) application to the FDA for its iStent infinite Trabecular Micro-Bypass System.

* Related Content: William Blair Downgrades Glaukos After Disappointing CMS Rate

* The iStent infinite is an investigational device designed 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.

* The iStent infinite trial at 12 months showed that 76% of subjects achieved a 20% or greater reduction in mean diurnal IOP from baseline on the same or lower ocular hypotensive medication burden.

* Over 50% of subjects achieved Month 12 IOP reduction greater than 30%.

* Subjects also achieved a 13% reduction in mean medication burden at 12 months.

* Price Action: GKOS shares traded 0.48% lower at $59.52 on the last check Friday.