■ Ivantis, developer of the novel Hydrus Microstent, a MIGS device designed to lower eye pressure for open-angle glaucoma patients, announce the first-ever release of 5-year follow-up data from its HORIZON pivotal trial. Ivantis says this represents the longest continuous follow-up of a MIGS device pivotal trial and comes on the heels of the Hydrus Microstent receiving the highest combined grades for Level of Evidence, Quality of Supporting Body of Evidence, and Recommendation for Care of any MIGS device reviewed by the American Academy of Ophthalmology in its 2020 Preferred Practice Pattern treatment guidelines. The 5-year HORIZON data demonstrated the Hydrus Microstent’s clinically meaningful and statistically significant clinical benefits over the full 5 years, including sustained reduction in the need for invasive secondary glaucoma surgery and medication use, which were observed without any increased safety risk.

The HORIZON study included 556 patients with mild to moderate glaucoma treated in 38 centers in 9 countries in North America, Europe, and Asia. It was designed to demonstrate the safety and efficacy of the Hydrus Microstent for lowering IOP in glaucoma patients undergoing planned cataract surgery. Patients were randomized 2:1 to receive cataract surgery plus the Hydrus Microstent or cataract surgery alone, respectively. The 2-year results provided the foundation for FDA approval in August 2018. The company said the 5-year update demonstrates the long-term safety and durability of the benefits that were observed earlier.