Ivantis is developing “the only minimally invasive microstent for glaucoma that dilates and reconstructs the primary outflow path of the eye,” said president and chief executive officer Dave Van Meter.
The company was founded almost a decade ago by top coronary stent inventors, and has raised $107 million to date.
“More than 2,700 patients have been treated with the Hydrus globally in 21 countries, with nearly 50% of procedures in stand-alone surgeries,” Van Meter said. The full two-year US pivotal trial results are about a year away, he added.
“Hydrus is the only device that reconstructs the eye’s natural outflow pathway,” Van Meter said. “It has superior clinical data within the initial served phaco-glaucoma market,” but its broadest potential will be in the stand-alone glaucoma market.
The Hydrus HORIZON pivotal trial is “the largest MIGS [microinvasive glaucoma surgery] clinical trial to date, with 558 patients,” he said. Of those, 67% are enrolled in North America, another 29% are enrolled in the EU, and 4% are enrolled in Asia.
Published results showed the Hydrus II produced a 20% drop in washed-out diurnal intraocular pressure (IOP) in 88% of patients at 12 months and in 80% at 24 months.
The device is showing “great versatility” as a stand-alone procedure – which Van Meter says may be three to five times the size of the combined phaco-MIGS market.
Published or presented data show a three-fold greater medication reduction in Hydrus patients at one year, with similar safety between the device and selective laser trabeculoplasty, similar efficacy to canaloplasty but with a better safety profile, and significant reductions in both medication use and IOP.
“The next step will be for us to leverage the platform” to include 24-hour pressure sensors on the device, Van Meter said.
Dave Van Meter
Dave joined Ivantis as President/CEO in 2008. Previously, starting in 2001, Dave worked at Abbott’s Vascular Division, where he was an early leader in the creation and growth of a business that grew from $60 to $400 MM from 2001 until 2006.