Glaukos announced the completion of patient enrollment in its FDA Investigational Device Exemption (IDE) trial for the iStent infinite Trabecular Micro-Bypass System.
The iStent infinite is designed for use in 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. The iStent infinite is similar to the company’s two-stent iStent inject Trabecular Micro-Bypass System, which was approved by the FDA in June 2018 for the reduction of IOP in adult mild-to-moderate primary open-angle glaucoma patients undergoing concomitant cataract surgery.
The iStent infinite prospective, unmasked, multicenter, single-arm clinical trial enrolled subjects who had undergone prior unsuccessful incisional glaucoma surgery and had IOP not adequately controlled with currently tolerated topical ocular hypotensive medications as well as subjects who had not undergone prior incisional glaucoma surgery but were on maximally tolerated topical ocular hypotensive 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.
The trial’s primary effectiveness endpoint is a 20% or greater reduction in mean diurnal IOP from baseline at 12 months postoperative on the same or fewer topical ocular hypotensive medications. Glaukos plans to use the trial results as the basis for seeking FDA approval of the iStent infinite.
“We expeditiously achieved this enrollment milestone due, in part, to the favorable safety profile surgeons experienced with their initial iStent infinite subjects, which helped to speed enrollment overall,” 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 with advanced glaucoma disease and at risk for significant vision loss. We look forward to working cooperatively with the FDA as the trial process moves forward, and we continue to target U.S. commercialization of the iStent infinite, if approved, by 2021.”