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Ivantis sends premarket approval submission for Hydrus microstent to FDA

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Ivantis has submitted a final premarket approval module to the FDA for its Hydrus microstent to lower IOP in open-angle glaucoma, according to a company press release.

The submission included data from the prospective, randomized HORIZON pivotal trial, in which 556 patients at 38 centers in nine countries received the MIGS device with cataract surgery or cataract surgery alone and were followed for 2 years.

The Hydrus is the size of an eyelash and is placed in Schlemm’s canal using a minimally invasive microsurgical procedure, the release said.

“The submission of Ivantis’ PMA marks a significant milestone toward our goal of bringing the Hydrus microstent to market in the United States in 2018, and we look forward to the FDA’s review,” Dave Van Meter, Ivantis president and CEO, said in the release.