Glaukos is one step closer to bringing a new Minimally invasive Glaucoma Surgery technology to the market. The San Clemente, CA-based company said it has submitted a supplemental PMA application to FDA for the iStent infiniteTrabecular Micro-Bypass System.
The device is designed 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.
Glaukos said the iStent infinite is similar to the company’s two-stent iStent inject W Trabecular Micro-Bypass System.
Results from the iStent infinite IDE pivotal study showed patients entered the trial 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.
Results go on to show 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.
During an August earnings call, Thomas Burns, president and CEO of Glaukos spoke of the promise of the iStent infinity and an update of when the device could be available on the market, according to a transcript from the Motley Fool.
“As a testament to this, we continue to invest in and advance our fulsome pipeline based on our core novel platforms where we anticipate and are planning for a robust cadence of new product introductions over the coming years that have the potential to significantly expand our addressable market opportunities and fundamentally transform Glaukos over time,” Burns said according to a transcript from the Motley Fool. “We are hard at work preparing for an iStent infinite regulatory submission and continue to target FDA approval around the end of this year.”