Ivantis Preparing for US Commercialization of Hydrus
The minimally invasive glaucoma surgery (MIGS) market is expected to grow from about $164 million in 2017 to $521 million by 2022, Ivantis CEO and President Dave Van Meter said. Ivantis has treated about 3,500 patients globally (22 countries, 87 centers) and is currently preparing for US commercialization in 2018 of its Hydrus MIGS device. “Our goal is to bring a more potent solution to Schlemm’s canal with our tri-modal mechanism of action,” Van Meter stated. First, the bypass allows fluid to enter the device; next, the permanent scaffold increases the long-term flow, and is the only device that spans 90 degrees, providing consistent access to multiple collector channels over time. The device targets such a large area there is “no need for targeting,” unlike some other devices. Ivantis’ HORIZON pivotal trial (n=556) is the largest MIGS trial to date to compare a MIGS device and phaco to phaco alone. HORIZON is also the only trial to cross three continents and nine countries. For patients who undergo MIGS surgery having been controlled on one medication, 87% remain medication-free at year 2 compared with 47% in the phaco-only arm. “These are the most resounding results” of any MIGS study, Van Meter asserted. Real-world experiences (including patients implanted during the learning curve) have mimicked the clinical trial results. The company’s SUMMIT trial is enrolling patients with refractory glaucoma (n=60); the COMPARE trial is a head-to-head trial comparing the Hydrus with two iStents (Glaukos) in patients with mild-to-moderate glaucoma (n=152). The COMPARE trial will read out in 2018.