Glaukos Completes Enrollment in U.S. Trial for New Glaucoma Device

Glaukos Corp., an ophthalmic medical technology company based in Laguna Hills, Calif., completed patient enrollment in its U.S. Food and Drug Administration (FDA) pivotal investigational device exemption (IDE) trial for the iStent inject Trabecular Micro-Bypass Stent.

The iStent inject relies on a similar fluidic method of action as the company’s flagship iStentTrabecular Micro-Bypass Stent, which was approved by the FDA in 2012 and has been shown to lower intraocular pressure in adult cataract patients with mild-to-moderate open-angle glaucoma. The iStent inject is composed of a micro-needle that is preloaded with two stents and driven by an auto-inject mechanism for predictable and facile implantation. The iStent inject is designed to enable ophthalmic surgeons to inject stents into multiple trabecular meshwork locations through a single corneal entry point. The iStent inject is approximately one-third the size of iStent, which Glaukos officials believe is the smallest device ever approved by the FDA.

The iStent inject prospective, randomized, multicenter clinical trial includes approximately 40 sites and 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 percent or greater reduction in intraocular pressure from baseline. The results of the trial are expected to form the basis for the company’s future premarket approval submission to the FDA. Health Canada recently approved the technology.

“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.”

The iStent inject is already approved for commercial use in the European Union and Australia, and Glaukos is currently conducting an initial commercial launch of iStent inject in Germany.
In addition to conducting an iStent inject U.S. IDE trial in combined cataract procedures, Glaukos is also conducting an initial U.S. IDE clinical trial to evaluate a second version of the iStent inject to be used as a standalone procedure in glaucoma patients who are not undergoing concurrent cataract surgery. The objective of this version of the iStent inject is to make micro-scale injectable therapy a viable option for a much larger segment of the patient population with open-angle glaucoma.

The company believes that approximately 20 perecent of the estimated 3.7 million cataract procedures performed annually in the United States are in patients also diagnosed with open-angle glaucoma or ocular hypertension. Glaucoma is characterized by progressive, irreversible and largely asymptomatic vision loss caused by optic nerve damage. There is no cure for the disease and reducing intraocular pressure is the only proven treatment. According to Market Scope, more than 78 million people worldwide have glaucoma, including 4.2 million people in the United States. Open-angle glaucoma is the most common form, affecting approximately 3.4 million people in the United States.