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Ivantis Reports 3-Year Data for Hydrus Microstent

■ Ivantis, developer of the FDA-approved Hydrus Microstent for glaucoma, has announced the 3-year results from the HORIZON pivotal study. The HORIZON study (556 patients) is the largest prospective, randomized, controlled trial conducted to date for a MIGS device, and the first to have a global span. The study included patients with mild-to-moderate glaucoma undergoing cataract surgery, and had a 2:1 randomization either to Hydrus Microstent plus cataract surgery, or cataract surgery alone.

Among the key findings at 3 years were that 73% of Hydrus patients remained medication free compared to 48% in the cataract-only arm. Also, of patients who entered the study on 1 medication, which represents approximately half of the glaucoma patients in the United States, 81% remained medication free compared to 48% in the cataract-only arm. Only 0.6% of Hydrus patients went on to subsequent invasive surgery to control glaucoma, compared to 3.9% in the cataract arm. The overall safety profile was similar to cataract surgery alone, including endothelial cell density stability from year 2 to year 3, with no significant change between the Hydrus group and cataract surgery group.