Glaukos (NYSE:GKOS) today released two-year data from the FDA investigational device exemption pivotal trial of its iStent inject trabecular micro-bypass system, and announced a patent infringement suit it filed against Ivantis.
Results of the 505-patient study were presented at the American Society of Cataracts and Refractive Surgery annual meeting by Dr. Thomas Samuelson of the Minnesota Eye Consultants, the San Clemente, Calif.-based company said.
The iStent inject trabecular micro-bypass system is designed to treat mild-to-moderate open-angle glaucoma in patients undergoing cataract surgery. It uses a pair of heparin-coated titanium stents in a pre-loaded auto-injection system that allows them to be injected into multiple trabecular meshwork locations via a single corneal entry point, the company said.
In the trial, subjects were randomized to two cohorts, with 387 patients receiving the iStent inject in combination with cataract surgery and 118 patients receiving cataract surgery only. Subjects in the trial were followed through two years with annual medication washouts, the company said.
Glaukos said that the trial met its primary and secondary effectiveness endpoints, and reported that the overall rate of adverse events between groups was similar.
At two years, 75.3% of the cohort who received the iStent inject achieved a 20% or greater reduction in unmedicated intraocular pressure compared to 61.9% in the cataract-surgery-only cohort. Mean unmedicated IOP amongst iStent patients was 6.9 mmHg compared to 5.4 mmHg for the cataract-only cohort.
Data indicated that at two years, the iStent inject cohort had a 31% mean reduction in unmedicated IOP of 17.11 mmHg from a baseline of 24.8 mmHG and that 62.6% of the cohort achieved an unmedicated mean IOP at or below 18 mmHg, compared to only 49.2% in the cataract-surgery-only cohort.
“The IOP-lowering capability of a single iStent in combination with cataract surgery has been well documented in the clinical literature, while various published studies and real-world international experience have also shown that multiple iStent devices can provide incremental IOP-lowering benefits. Given its performance and enhanced ease-of-use, we believe the iStent inject, if approved by the FDA, will be an attractive, two-stent option for U.S. ophthalmic surgeons to reliably manage glaucoma patients’ IOP in a straightforward and effective manner,” prez & CEO Thomas Burns said in a press release.
In a separate release, Glaukos announced it filed a patent infringement suit in the US District Court for the Central District of California, Southern division, against competitor Ivantis.
In the suit, the company claims that Ivantis’ Hydrus Microstent device infringes on patents Glaukos owns related to its core glaucoma technology.
“Since our founding in 1998, Glaukos has invested considerable time and resources to develop novel technologies that create entirely new treatment options for glaucoma surgeons and their patients. This lawsuit reflects our unwavering commitment to protect our proprietary inventions for the benefit of patients, customers, shareholders, employees and others who rely on us,” CEO Burns said in a prepared statement.
In February, Glaukos released results from a study of its iStent trabecular micro-bypass stent exploring its use during cataract surgery in patients with severe open-angle glaucoma, touting significant reductions in intraocular pressure and medication use.
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