Glaukos touts 2-year iStent inject pivotal trial data, levies infringement suit against Ivantis

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 i...
Source: Mass Device - Category: Medical Devices Authors: Tags: Clinical Trials Optical/Ophthalmic Patent Infringement Glaukos Source Type: news