Glaukos files PMA bid for iStent Inject glaucoma treatment

Glaukos (NYSE:GKOS) said today that it filed for pre-market approval from the FDA of its iStent Inject trabecular micro-bypass stent for treating glaucoma.

San Clemente, Calif.-based Glaukos said the device is designed to treat mild-to-moderate open-angle glaucoma in patients undergoing cataract surgery. It used a pair of heparin-coated titanium stents in a pre-loaded auto-injection system that allows them to be injected into multiple trabecular meshwork locations via a single corneal entry point.

“This PMA submission marks a significant milestone for Glaukos as we continue to deliver our deep pipeline of novel glaucoma surgical devices and sustained pharmaceuticals,” president & CEO Thomas Burns said in prepared remarks. “The iStent Inject represents the first in a series of five new products we are expecting to introduce over the next five years, culminating in what we believe will be the industry’s broadest portfolio of technologies designed to address the full range of glaucoma disease states and progression.”

The PMA bid is backed by data from a 505-patient trial randomized to either treatment with iStent Inject plus cataract surgery, or cataract surgery alone. Data from the study is slated to be released next year, Glaukos said.

Last week Glaukos won an investigational device exemption from the FDA for a pivotal study of its iStent SA device.

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