Glaukos announced that 12-month U.S. Investigational Device Exemption (IDE) pivotal trial data showed that its iStent infinite Trabecular Micro-Bypass System achieved a substantial reduction in mean diurnal IOP in patients with open-angle glaucoma uncontrolled by prior surgical or medical therapy.
The iStent infinite prospective, unmasked, multicenter, single-arm clinical trial enrolled subjects who had undergone prior unsuccessful incisional or cilioablative glaucoma surgery and had IOP not adequately controlled with IOP-lowering medications as well as subjects who had not undergone prior incisional or cilioablative glaucoma surgery but were on maximally tolerated IOP-lowering medications with uncontrolled IOP. In the trial, 72 subjects were implanted with the iStent infinite at 15 separate clinical sites. All surgeons performing the iStent infinite procedures were board-certified glaucoma specialists.
Patients entered the iStent infinite IDE pivotal study with a mean baseline IOP of 23.4 mmHg on an average of 3.1 medications and an average of 2 failed prior surgeries. At 12 months, 76% of subjects achieved 20% or greater reduction in mean diurnal IOP from baseline on the same or lower ocular hypotensive medication burden. Further, more than 50% of subjects achieved Month 12 IOP reduction ≥ 30%. Subjects also achieved a 13% mean reduction in medication burden at 12 months. The safety profile in the study was highly favorable, with no explants, infections or device-related interventions or hypotony reported through 12 months.
“We are excited to announce this strong pivotal data highlighting the favorable safety and effectiveness of the iStent infinite. These data further underscore our view that iStent infinite may provide ophthalmic surgeons with a compelling new treatment alternative in a standalone procedure for patients with open-angle glaucoma uncontrolled by prior surgical or medical therapy,” Thomas Burns, Glaukos president and chief executive officer, said in a company news release. “We appreciate the commitment and dedication of the clinical investigators, who play a vital role in bringing new innovations to patients suffering from glaucoma and at risk for significant vision loss. We look forward to working cooperatively with the FDA as we prepare for an upcoming regulatory submission and continue to target U.S. approval of the iStent infinite in late 2021.”
The iStent infinite is an investigational device designed for use in a standalone procedure to reduce elevated IOP in patients with open-angle glaucoma uncontrolled by prior surgical or medical therapy. It includes three heparin-coated titanium stents preloaded into an auto-injection system that allows the surgeon to inject stents across a span of approximately 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. The iStent infinite is similar to the company’s two-stent iStent inject W Trabecular Micro-Bypass System, which is approved by the FDA for the reduction of IOP in adult mild-to-moderate primary open-angle glaucoma patients undergoing concomitant cataract surgery.
Glaukos pioneered Micro-Invasive Glaucoma Surgery (MIGS), which involves insertion of a micro-scale device from within the eye’s anterior chamber through a small corneal incision. Glaukos’ MIGS devices are designed to reduce IOP by restoring the natural outflow pathways for aqueous humor. Glaukos received U.S. Food and Drug Administration (FDA) approval for its first-generation MIGS device, the iStent®, in 2012. Its second-generation iStent inject, which received FDA approval in 2018, and its latest iStent inject W device, which received FDA approval in 2020, include two stents preloaded in an auto-injection mechanism that facilitates stent insertion into multiple trabecular meshwork locations through a single corneal incision. The iStent inject is also approved in the European Union, Armenia, Australia, Brazil, Canada, Hong Kong, Japan, Singapore and other international markets. Glaukos is pursuing FDA approval for additional MIGS surgical and sustained pharmaceutical therapy pipeline products, all of which are investigational in the United States.