■ Glaukos Corporation 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 3 heparin-coated titanium stents preloaded into an autoinjection system that allows the surgeon to inject stents across a span of 5 to 6 clock hours around Schlemm’s canal. Once in place, the stents are designed to lower IOP by restoring the natural physiologic outflow of aqueous humor. The iStent infinite is similar to the company’s 2-stent iStent inject Trabecular Micro-Bypass System, 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.
The trial’s primary effectiveness endpoint is a 20% or greater reduction in mean diurnal IOP from baseline at 12 months postoperatively 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.