Ivantis touts pivotal data for tiny eye stent
|The Hydrus Microstent is about the size of an eyelash.--Courtesy of Ivantis|
Ivantis' eyelash-sized eye stent helped lower intraocular pressure after one year in patients who have undergone cataract surgery, data that could help the company convince the FDA of its device's utility.
In a study of 100 European patients with mild to moderate glaucoma, Ivantis' Hydrus Microstent lowered in-eye pressure by 20% or more in 92% of subjects, the company said, and Hydrus patients were about half as likely to need topical ocular treatments than those in the control group.
The tiny Hydrus is inserted into the eye through a minimally invasive procedure, Ivantis said, providing relief from eye pressure by restoring natural outflow for built-up fluids in patients recovering from glaucoma surgery.
The latest European study, HYDRUS II, is running concurrently with the HYDRUS IV pivotal trial in the U.S., and Ivantis plans to roll all its data together for an eventual FDA application, giving "surgeons, patients and our investors ... reason for great optimism," CEO Dave Van Meter said in a statement.
In February, Ivantis hauled in $27 million from the likes of New Enterprise Associates, Ascension Health Ventures and Delphi Ventures. That cash is funding Ivantis' ongoing studies of Hydrus, and Van Meter said the company is focused on demonstrating the stent's safety, efficacy and cost-effectiveness.
"Glaucoma medication in the U.S. costs our system nearly $3 billion per year, and studies show that 50% of patients are not compliant with their medications within 6 months of diagnosis," Van Meter said in February. "It's a grossly inefficient delivery of care at a high cost."
Ivantis will eventually have to compete with Glaukos and its FDA-approved iStent, also designed to relieve eye pressure caused by fluid buildup during cataract surgeries on glaucoma patients. Glaukos raised $30 million this year to commercialize its device, funded by OrbiMed, InterWest and Facebook ($FB) investor Meritech.
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