The iStent infinite is an investigational device intended for use in a standalone procedure to minimise elevated intraocular pressure in patients with open-angle glaucoma uncontrolled by prior surgical or medical therapy
Ophthalmic medical technology company Glaukos is seeking approval from the US Food and Drug Administration (FDA) for its iStent infinite trabecular micro-bypass system.
The company has submitted a supplemental pre-market approval (PMA) application to the regulator for the iStent infinite system.
Glaukos’ iStent infinite is an investigational device intended for use in a standalone procedure to minimise elevated intraocular pressure (IOP) in patients with open-angle glaucoma uncontrolled by prior surgical or medical therapy.
Consisting of three heparin-coated titanium stents preloaded into an auto-injection system, the device enables the surgeon to inject stents across a span of up to six clock hours around Schlemm’s canal, the eye’s primary drainage channel.
Upon the placement, the stents will reduce IOP through restoring the natural and physiological outflow of aqueous humor.
According to the company, the iStent infinite is similar to the firm’s two-stent iStent inject W trabecular micro-bypass system, which secured FDA approval to reduce IOP in adult mild-to-moderate primary open-angle glaucoma patients undergoing concomitant cataract surgery.
Glaukos president and CEO Thomas Burns said: “This filing marks a significant achievement for Glaukos as we continue to advance our deep pipeline of novel glaucoma surgical devices and sustained pharmaceuticals.
“Supported by strong pivotal data highlighting favorable safety and effectiveness, we believe iStent infinite may provide ophthalmic surgeons with a compelling new treatment alternative in a standalone procedure for patients with open-angle glaucoma uncontrolled by prior surgical or medical therapy.”
The iStent infinite prospective, unmasked, multi-centre, and single-arm clinical study recruited subjects who had undergone prior unsuccessful incisional or cilioablative glaucoma surgery and had IOP not adequately controlled with IOP-lowering medications.
In addition, the trial included subjects who had not undergone prior incisional or cilioablative glaucoma surgery but were on maximally tolerated IOP-lowering medications with uncontrolled IOP.
The company had implanted 72 subjects with the iStent infinite at 15 separate clinical sites in the study.