Glaukos announced that it has submitted an investigational device exemption (IDE) application to the FDA seeking authorization to study its iStent infinite Trabecular Micro-Bypass System.
The iStent infinite is designed for use as a standalone procedure to reduce elevated IOP in refractory glaucoma patients. It includes three heparin-coated titanium stents preloaded into an auto-injection system that allows the surgeon to inject stents across a span of five to six clock hours around Schlemm’s canal, the eye’s primary drainage channel. Once in place, the stents are designed to lower IOP by restoring the natural, physiological outflow of aqueous humor.
“We look forward to working cooperatively with the FDA as they review our IDE application – an application that marks another milestone achievement towards our goal to deliver a comprehensive pipeline of micro-scale glaucoma devices and sustained therapy pharmaceuticals,” Thomas Burns, president and chief executive officer, said in a company news release. “We believe the iStent infinite will be an important addition to our product offering by providing ophthalmic physicians and their refractory glaucoma patients an attractive micro-invasive treatment alternative to more invasive and complex surgical interventions.”
In the IDE application, Glaukos proposes to conduct a prospective, multicenter, single-arm clinical trial to evaluate safety and performance of the iStent infinite in approximately 65 refractory subjects and/or subjects on maximally tolerated topical ocular hypotensive medications. The primary endpoint is proposed to be a 20% or greater reduction in IOP from baseline at 12 months on the same or fewer medications. Glaukos plans to use the trial results as the basis for seeking FDA clearance via a 510k pre-market submission.
The iStent infinite relies on the same fluidic method of action as the company’s first-generation iStent Trabecular Micro-Bypass Stent, which was approved by the FDA in 2012 and has been shown to lower IOP in adult cataract patients with mild-to-moderate open-angle glaucoma. Each iStent infinite stent is approximately 0.36 mm x 0.36 mm, or about one-third the size of iStent, which the company believes is the smallest medical device ever approved by the FDA.
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 IOP is the only proven treatment. Based on analysis of population-based surveys, medical claims data and other statistics, the company estimates that there are approximately 5.4 million people in the U.S. with primary open-angle glaucoma, the most common form of the disease.