FDA Clears Hydrus Microstent for Glaucoma

Megan Brooks

August 14, 2018

The US Food and Drug Administration (FDA) has approved the Hydrus (Ivantis) microstent to treat mild-to-moderate, primary open-angle glaucoma in conjunction with cataract surgery.

Roughly the size of an eyelash, the Hydrus microstent is a next-generation device designed to reduce eye pressure by reestablishing the eye's natural outflow through Schlemm's canal. According to the company, when placed in the canal during minimally invasive microsurgery, the device restores the flow of fluid by creating a bypass through the trabecular meshwork, allowing outflow of aqueous humor, and dilates and scaffolds Schlemm's canal to enhance outflow. The device spans 90 degrees of the canal to provide consistent access to the fluid collector channels in the eye.

The FDA approved the Hydrus microstent based on results of the global HORIZON trial involving 556 patients from 38 centers in nine countries with mild-to-moderate glaucoma having cataract surgery. Patients were randomly assigned to treatment with the Hydrus microstent or cataract surgery alone.

In the study, 77.2% of patients in the Hydrus group saw a greater than 20% reduction in unmedicated intraocular pressure (IOP) 24 months after surgery, significantly higher than the 57.8% reduction in the control group. The mean reduction in IOP with the Hydrus microstent was 7.5 mm Hg, a difference of 2.3 mm Hg compared with that in the control group.

In April, data from the HORIZON US cohort of 331 patients treated at 26 centers in the United States were presented at the American Society of Cataract and Refractive Surgery in Washington, DC.

The 24-month US cohort data, analyzed with the conservative intention-to-treat methodology, showed that 79% of Hydrus microstent patients achieved a 20% or greater reduction in IOP compared with 55% in the cataract-only group. The Hydrus microstent reduced IOP 50% more than cataract surgery alone (7.9 mm Hg vs 5.2 mm Hg, a difference of 2.7 mm Hg). Twice the number of Hydrus microstent patients remained medication-free compared with those in the control group (79% vs 39%).

"These are the best results we have seen to date in a US patient population from a randomized controlled MIGS [minimally invasive glaucoma surgery] trial," Iqbal "Ike" Ahmed, MD, research director, Kensington Eye Institute, and director, Glaucoma and Advanced Anterior Segment Surgery Fellowship Program at the University of Toronto in Ontario, Canada, said at the time in a company news release.

"As a glaucoma specialist, it's encouraging to see more robust improvements in IOP lowering compared to cataract surgery alone. A near 3-point improvement in IOP lowering compared to control is significant, and clearly this benefit will help keep patients on fewer medications," Ahmed said.

"Whereas the global Horizon results were excellent, the US cohort results appear even stronger and may give us even greater insights into differences in how patients are treated with MIGS from region to region," he added.

The company intends to launch the Hydrus microstent later this year.

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