Ivantis Completes PMA Submission for Hydrus Microstent

November 3, 2017: By Jon Swedien
Ivantis Hydrus

Ivantis Hydrus

Ivantis has submitted to the US FDA its final premarket approval (PMA) module for the Hydrus Microstent as a treatment for open-angle glaucoma, the Irvine, California, company announced Oct. 31.

The Hydrus is a minimally invasive glaucoma surgery (MIGS) device designed to reduce intraocular pressure (IOP). Roughly the size of an eyelash, the device opens a bypass through the trabecular meshwork and then dilates and scaffolds Schlemm’s canal to enhance outflow.

The submission is based on the HORIZON pivotal trial, a 556 patient, prospective, randomized trial conducted at 38 centers in nine countries. Study subjects with mild to moderate primary open-angle glaucoma were randomized to receive cataract surgery alone or cataract surgery plus the Hydrus. Subjects were followed for two years. The HORIZON Study is the largest MIGS randomized controlled trial completed to date and the first pivotal trial to span the globe, Ivantis said.

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