Glaukos (NYSE:GKOS) announced today that it submitted a supplemental premarket approval application to the FDA for its iStent Infinite system.
San Clemente, California–based Glaukos designed the iStent Infinite trabecular micro-bypass system for use in a standalone procedure to reduce elevated intraocular pressure (IOP) in patients with open-angle glaucoma uncontrolled by prior surgery or medical therapy.
According to a news release, the platform 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 eye’s primary drainage channel. Glaukos designed the stents so that, once in place, they lower IOP by restoring the natural, physiological outflow of aqueous humor.
Glaukos developed the iStent Infinite to be similar to its two-stent iStent Inject W trabecular micro-bypass system that holds FDA approval for reducing IOP in adult mild-to-moderate primary open-angle glaucoma patients undergoing concomitant cataract surgery.
Clinical data from a prospective, unmasked, multi-center trial of 72 subjects across 15 sites found that, at 12 months, 76% of subjects achieved a 20% or greater reduction in mean diurnal IOP from baseline on the same or lower ocular hypotensive medication burden. In addition, more than 50% of subjects achieved a 12-month IOP reduction of greater than or equal to 30%.
“This filing marks a significant achievement for Glaukos as we continue to advance our deep pipeline of novel glaucoma surgical devices and sustained pharmaceuticals,” Glaukos president & CEO Thomas Burns said in the release. “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.”