Ophthalmic medical technology and pharmaceutical company Glaukos Corporation has received clearance from the US Food and Drug Administration (FDA) for its iStent infinite trabecular micro-bypass system.
The novel system is indicated for use in a standalone procedure to reduce elevated intraocular pressure (IOP) in patients with primary open-angle glaucoma uncontrolled by prior medical and surgical therapy.
The iStent infinite 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 has a similar mechanism of action to the company’s two-stent iStent inject 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.
Glaukos chairman and CEO, Mr Thomas Burns, expressed his gratitude to the researchers and patients who took part in the device’s critical trials.
“This FDA clearance for iStent infinite represents a significant milestone for Glaukos and the MIGS market as the first FDA-cleared micro-invasive implantable device indicated for use as a standalone treatment option for glaucoma patients not undergoing concomitant cataract surgery,” Burns said.
“Supported by strong pivotal data highlighting favourable safety and effectiveness, we believe iStent infinite provides ophthalmic surgeons a compelling new interventional glaucoma alternative designed to provide foundational, 24/7 IOP control for their patients in need.
“We are grateful to the clinical investigators and patients who participated in the clinical trial for their instrumental roles in helping us reach this pioneering achievement and bring iStent infinite to the US.”
After launching its first micro-invasive glaucoma surgery (MIGS) device commercially in 2012, Glaukos has since developed a portfolio of technologically distinct platforms to support ongoing pharmaceutical and medical device innovations.
The company intends to commence initial commercial launch activities for iStent infinite later this year.