Glaukos announced that it has submitted a premarket approval (PMA) application to the FDA for the iStent inject Trabecular Micro-Bypass Stent.
The iStent inject is designed to improve aqueous humor outflow into Schlemm’s canal and reduce IOP in mild-to-moderate open-angle glaucoma patients undergoing cataract surgery. It includes two heparin-coated titanium stents preloaded into an auto-injection system that allows the surgeon to inject stents into multiple trabecular meshwork locations through a single corneal entry point.
“This PMA submission marks a significant milestone for Glaukos as we continue to deliver our deep pipeline of novel glaucoma surgical devices and sustained pharmaceuticals,” Thomas Burns, president and chief executive officer, said in a company news release. “The iStent inject represents the first in a series of five new products we are expecting to introduce over the next 5 years, culminating in what we believe will be the industry’s broadest portfolio of technologies designed to address the full range of glaucoma disease states and progression.”
The iStent inject prospective, randomized, multicenter clinical trial included 41 sites and 505 randomized subjects who received either iStent inject in combination with cataract surgery or cataract surgery alone. The iStent inject met its primary effectiveness endpoint in the trial, which was a 20% or greater reduction in IOP from baseline at 24 months. The company plans to release efficacy and safety data from the trial sometime in the first half of 2018.
The iStent inject 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 inject stent is approximately 0.23 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.
The iStent inject is currently approved for use in the European Union, Armenia, Australia, Brazil, Canada, Hong Kong, Singapore and South Africa.