Glaukos has received the US Food and Drug Administration (FDA) premarket approval for its iStent infinite trabecular micro-bypass system to reduce intraocular pressure (IOP) in patients with primary open-angle glaucoma.
Developed with a similar mechanism of action to the company’s two-stent iStent inject, the iStent infinite includes three heparin-coated titanium stents preloaded into an auto-injection system, allowing the surgeon to inject stents across a span of up to approximately six clock hours around Schlemm’s canal. The stents are designed to restore the natural outflow of aqueous humour in patients whose IOP is uncontrolled by prior medical and surgical therapy.
The FDA clearance represents a significant milestone for Glaukos, said Thomas Burns, chairman and CEO. “Supported by strong pivotal data highlighting favourable safety and effectiveness, we believe iStent infinite provides ophthalmic surgeons a compelling new interventional glaucoma alternative.”
The commercial launch is scheduled for late 2022.
