On June 25th, 2018, Glaukos Corporation announced it received premarket approval (PMA) from the FDA for the iStent inject® Trabecular Micro-Bypass System.  The iStent inject® is indicated for the reduction of intraocular pressure (IOP) in adult mild-to-moderate primary open-angle glaucoma (POAG) patients who are also undergoing cataract surgery.

In order to achieve their goal of transforming the treatment of glaucoma, Glaukos had to conduct clinical trials in order to get this exciting FDA approval.

Their initial clinical trial included 41 investigational sites and 505 mild-to-moderate POAG eyes that were randomized to receive iStent inject in combination with cataract surgery or just cataract surgery only.

Our very own, Dr. Carlos Buznego, MD, was one of the first involved in the clinical trial in the USA in 2010 and one of the first of 20 doctors to implant the device that it is now commercially available to patients!

What is the iStent inject?

The iStent inject is designed to optimize the natural outflow of aqueous humor by creating two patent bypasses through the trabecular meshwork, the main source of resistance in eyes with glaucoma.   These bypasses result in multi-directional flow through Schlemm’s canal.

It includes two heparin-coated titanium stents preloaded into an auto-injection system that allows the surgeon to precisely implant stents into two trabecular meshwork locations through a single corneal entry point in a straightforward click-and-release motion.

The iStent inject is the Glaukos’s next-generation trabecular micro-bypass technology and is based on the same fluidic method of action as the company’s first-generation pioneering iStent^®, which has been implanted in more than 400,000 eyes worldwide since its introduction in 2012 and has earned a reputation of demonstrated efficacy and safety.

Each iStent inject stent is approximately 0.23 mm x 0.36 mm, or about one-third the size of the first-generation iStent. The company believes the iStent inject is the smallest medical device ever approved by the FDA.

More about the actual iStent trial

The FDA approval is based on the iStent inject U.S. IDE pivotal study, a prospective, randomized, multicenter clinical trial that included 41 investigational sites and 505 mild-to-moderate POAG eyes that were randomized to receive iStent inject in combination with cataract surgery or cataract surgery only. The Center for Excellence in Eye Care was part of this trial!

The pivotal trial data show that the iStent inject achieved a statistically significant reduction in unmedicated daily IOP in patients undergoing cataract surgery at 24 months as 75.8% of the iStent inject cohort achieved a 20% or greater reduction in unmedicated IOP and the mean unmedicated IOP reduction was 7.0 mmHg for the iStent inject cohort.

In addition to meeting the study’s primary and secondary effectiveness endpoints, at 24 months, observed data show that the iStent inject cohort achieved a 31% mean reduction, or 7.7 mmHg, in unmedicated IOP from an unmedicated mean baseline IOP of 24.8 mmHg to 17.1 mmHg.

Finally, through 24 months, the overall rate of adverse events for the iStent inject cohort was similar to cataract surgery alone.

What this means is as much risk as regular cataract surgery (so no increased risk when you add iStent) and a better glaucoma outcome for patients!  It means lowering of IOP and at the end of the day what every glaucoma patient dreams of…less of a need for daily drops after their surgery!

If you or a loved one has been diagnosed with glaucoma and are interested in knowing whether you are a candidate for the iStent inject, please call our office for an appointment with Dr. Carlos Buznego at 305-598-2020!