Glaukos gets premarket FDA OK for intraocular stent

Glaukos announced it has received premarket approval, or PMA, from the FDA for the iStent inject Trabecular Micro-Bypass System indicated for the reduction of intraocular pressure, or IOP, in adult mild-to-moderate primary open-angle glaucoma, or POAG, patients undergoing concomitant cataract surgery. The iStent inject is designed to optimize the natural physiological outflow of aqueous humor by creating two patent bypasses through the trabecular meshwork, the main source of resistance in glaucomatous eyes, resulting in multi-directional flow through Schlemm’s canal. It includes two heparin-coated titanium stents preloaded into an auto-injection system that allows the surgeon to precisely implant stents into two trabecular meshwork locations through a single corneal entry point in a straightforward click-and-release motion. The iStent inject is the company’s next-generation trabecular micro-bypass technology and is based on the same fluidic method of action as the company’s first-generation pioneering iStent, which has been implanted in more than 400,000 eyes worldwide since its introduction in 2012 and has earned a reputation of demonstrated efficacy and safety.

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