Glaucoma solutions developer Glaukos Corporation, has completed patient enrollment in its U.S. FDA pivotal Investigational Device Exemption (IDE) trial for the iStent inject® Trabecular Micro-Bypass Stent.
Glaukos pioneered Micro-Invasive Glaucoma Surgery, or MIGS, and launched the iStent®, its first MIGS device, in the United States in July 2012. The iStent inject relies on a similar fluidic method of action as the company’s flagship iStent® Trabecular Micro-Bypass Stent which has been shown to lower intraocular pressure in adult cataract patients with mild-to-moderate open-angle glaucoma. The iStent inject is comprised of a micro-needle that is preloaded with two stents and driven by an auto-inject mechanism for predictable and easy implantation. The iStent inject is designed to enable ophthalmic surgeons to inject stents into multiple trabecular meshwork locations through a single corneal entry point. It is approximately one-third the size of iStent, which Glaukos believes is the smallest device ever approved by the FDA.
The iStent inject is already approved for sale in Europe and Australia, and is now making progress towards U.S. FDA approval, subject to results from its prospective, randomized, multicenter clinical trial at approximately 40 sites with 500 randomized subjects. Subjects in the trial are randomized to either iStent inject in combination with cataract surgery or cataract surgery alone. The study protocol calls for randomized subjects to be followed for two years, with a primary endpoint of a 20% or greater reduction in intraocular pressure from baseline.
“Glaukos has pioneered the new Micro-Invasive Glaucoma Surgery market and clinical class and is dedicated to transforming glaucoma therapy for patients worldwide,” said Thomas Burns, president and CEO of Glaukos. “Our completion of the iStent inject U.S. pivotal trial patient enrollment and the achievement of our patient randomization goal marks another milestone towards introducing breakthrough technologies that can advance glaucoma patient care.”
Source: Business Wire