Glaukos Files PMA with US FDA for iStent Inject as Glaucoma Treatment

December 29, 2017: By Jon Swedien

Glaukos has submitted a premarket approval (PMA) application to the US FDA for the iStent Inject Trabecular Micro-Bypass Stent, the San Clemente, California, company announced Dec. 27.

The iStent Inject is designed to improve aqueous humor outflow into Schlemm’s canal and reduce intraocular pressure (IOP) in mild to moderate open-angle glaucoma patients undergoing cataract surgery, Glaukos said.

It includes two heparin-coated titanium stents preloaded in an auto-injection system that allows the surgeon to inject stents into multiple trabecular meshwork locations through a single corneal entry point, the company said.

The iStent Inject met its primary effectiveness endpoint—a 20 percent or greater reduction in IOP from baseline at 24 months—in a prospective, randomized, multicenter clinical trial that included 41 sites and 505 randomized subjects, the company said. Glaukos said it plans to release efficacy and safety data from the trial in the first half of 2018.

The iStent Inject is currently approved for use in the European Union, Armenia, Australia, Brazil, Canada, Hong Kong, Singapore, and South Africa, Glaukos said.

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