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Ivantis' Hydrus microstent receives FDA approval

04/10/2018
Ivantis has received FDA approval of the Hydrus microstent, designed to treat patients with mild to moderate primary open-angle glaucoma in conjunction with cataract surgery.

Dave Van Meter, Ivantis CEO said he was pleased with the FDA approval adding, “Although the device has been used in over 4,000 procedures internationally, many of which are now well past five years, the Hydrus Microstent represents a novel device platform to FDA, and this approval occurred within our projected timeline. We are now proceeding with building our commercial and manufacturing infrastructures and intend to launch the product later this year.”

Australia became the first country to gain access to Hydrus microstent when it was approved for use in 2013. However, its developer Ivantis chose to collect clinical data via a select group of surgeons who trialled its use under a registry study profile before taking it to market.

“We were building a database of clinical results in order to provide some real-world outcomes into the market when we launched,” managing director for Ivantis Asia Pacific, Mr Glen Burgess said.


"The overall body of clinical data supporting Hydrus is very encouraging in terms of both safety and two-year efficacy."
David Chang, UC San Fransisco

The FDA approval was based on the results of the Horizon trial, which included 556 mild-to-moderate glaucoma patients who underwent cataract surgery. The patients were randomly assigned to receive either cataract surgery plus the Hydrus microstent or cataract surgery alone.

According to the trial results, more than 77% of patients who received the microstent experienced a statistically significant decrease in un-medicated IOP at 24 months postoperatively compared with 57.8% of patients who underwent cataract surgery alone.

The device also reached its secondary effectiveness endpoint, with Hydrus patients achieving a mean IOP reduction of 7.5 mm Hg, a 2.3 mm Hg difference compared with the control group.

The Hydrus microstent is designed to reduce eye pressure by re-establishing flow through Schlemm’s canal. It creates a bypass through the trabecular meshwork, and dilates and scaffolds the canal to augment outflow, according to the release.

Dr David Chang, clinical professor of Ophthalmology at the University of California, San Francisco said US ophthalmologists will welcome the approval.

“The Hydrus Microstent scaffolds approximately 90 degrees of the patient’s natural canal outflow pathway. Correct anatomic placement into the canal will also be easier for surgeons to confirm. The overall body of clinical data supporting Hydrus is very encouraging in terms of both safety and two-year efficacy and sets a new bar for the treatment of mildto moderate glaucoma in cataract patients. It also appears to be very effective at eliminating medications, compared to cataract surgery alone. I look forward to offering Hydrus to my patients,” Chang said.

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