Glaukos announced the completion of patient enrollment in the pivotal phase of its FDA investigational device exemption (IDE) trial for the iStent Supra Suprachoroidal Micro-Bypass Stent.
The iStent Supra prospective, randomized clinical trial includes 36 sites and 505 subjects with mild-to-moderate primary open-angle glaucoma and cataracts. Subjects were randomized to receive either iStent Supra in combination with cataract surgery or cataract surgery alone. The study has a 24-month primary outcome measure of a 20% or greater reduction in IOP from baseline. The results of the trial are expected to form the basis for the company’s future premarket approval (PMA) submission to the FDA.
The iStent Supra is designed to reduce IOP by accessing the suprachoroidal space in the eye. Approximately 4.0 mm in length and curved to follow the eye’s anatomy, the iStent Supra is already approved for marketing in the European Union and certain other countries outside the United States.
“We expect the iStent Supra to ultimately be an important part of ophthalmic surgeons’ armamentarium for effectively managing IOP,” Thomas Burns, Glaukos president and chief executive officer, said in a company news release. “Achieving this enrollment milestone represents an important step forward in our goal to provide surgeons and their patients a comprehensive set of options to address a range of glaucoma disease state and progression.”
Glaukos pioneered MicroInvasive Glaucoma Surgery, or MIGS, and introduced the industry’s flagship MIGS device, the iStent Trabecular Micro-Bypass Stent, in 2012. The iStent accesses the eye’s conventional pathway for aqueous humor outflow, which is through the trabecular meshwork and into Schlemm’s canal. The company is also conducting FDA clinical trials for two versions of its next-generation iStent injectTrabecular Micro-Bypass Stent, one version to be used in combination with cataract surgery and the other version to be used in a standalone procedure.