Glaukos has filed a supplemental pre-market approval application with the US Food and Drug Administration (FDA) for its iStent Infinite trabecular micro-bypass system.
The investigational device is designed to reduce elevated intraocular pressure (IOP) in patients with open-angle glaucoma uncontrolled by prior surgical or medical therapy. Similar to the company’s already FDA-approved two-stent iStent Inject W trabecular micro-bypass system, the iStent Infinite includes three heparin-coated titanium stents preloaded into an auto-injection system, allowing stents to be injected across a span of up to six clock hours around Schlemm’s canal.
The iStent Infinite is supported by strong key data highlighting favourable safety and effectiveness, making it a compelling new treatment alternative, said Thomas Burns, Glaukos CEO.
For more Glaukos news, see http://www.eyeonoptics.co.nz/articles/archive/glaukos-accepts-ivantis-60m-settlement/
