14 November 2017 - - Irvine, California-based ocular technologies specialist Ivantis Inc.'s HORIZON pivotal study has met both the two year primary and secondary pre-established endpoints, exceeding those of any minimally invasive glaucoma surgery (MIGS) pivotal trial to date, the company said.
The HORIZON study of 556 patients conducted at 38 centers in nine countries on three continents is the largest prospective, randomized, controlled trial conducted to date for a MIGS device, and the first to have a global span.
The study was designed to demonstrate the safety and efficacy of the Hydrus Microstent in lowering intraocular pressure (IOP) in glaucoma patients undergoing cataract surgery.
Two-year follow-up data from the HORIZON trial showed that 77.2% of Hydrus Microstent patients achieved a 20% or greater reduction in IOP, compared to 57.8% in the cataract-only group, the largest treatment effect reported in a MIGS pivotal trial at 24 months.
Hydrus Microstent reduced IOP 43% more than cataract surgery alone (7.6 mmHg vs. 5.3 mmHg), the largest difference in IOP reduction reported in a MIGS pivotal trial at 24 months, and 78% of Hydrus Microstent patients remained medication-free compared to 48% in the control group, again the highest margin of total medication elimination compared to control of any MIGS pivotal trial at 24 months.
Additionally, the treatment effect in the Hydrus Microstent group increased from year one to year two as compared to the control group, suggesting an increasing benefit over time. 
Roughly the size of an eyelash, the Hydrus Microstent is a next-generation MIGS device designed to reduce eye pressure by reestablishing flow through Schlemm's canal, the eye's natural outflow pathway.
Ivantis is a privately held company established to design, develop, and commercialize new technologies to treat eye disease.