iStent inject micro-bypass system receives FDA approval

The iStent inject is designed to optimise the natural physiological outflow of aqueous humor by creating two patent bypasses through the trabecular meshwork, the main source of resistance in glaucomatous eyes, resulting 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 company’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 0.23mm x 0.36mm, 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.

“U.S. ophthalmic surgeons have been eagerly awaiting the availability of iStent inject, which offers them an exciting new treatment option for effectively managing glaucoma patients’ IOP while potentially reducing or eliminating the need for topical hypotensive medications,” said Thomas W. Samuelson, MD, a surgeon at Minnesota Eye Consultants, Adjunct Professor at the University of Minnesota and an investigator in the U.S. iStent inject pivotal trial.

“The results of the U.S. trial, along with those of numerous international peer-reviewed studies, confirm that iStent inject provides predictable, clinically significant IOP reductions with an excellent safety profile through an elegant, micro-invasive procedure with minimal tissue disruption.”

The FDA approval is based on the iStent inject U.S. IDE pivotal study, a prospective, randomised, multicenter clinical trial that included 41 investigational sites and 505 mild-to-moderate POAG eyes that were randomised to receive iStent inject in combination with cataract surgery (n=387) or cataract surgery only (n=118.)

The pivotal trial data show that the iStent inject achieved a statistically significant reduction in unmedicated diurnal 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 7.0mmHg 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 7.7mmHg, in unmedicated IOP from an unmedicated mean baseline IOP of 24.8mmHg to 17.1mmHg. Finally, through 24 months, the overall rate of adverse events for the iStent inject cohort was similar to cataract surgery alone.

“The approval of iStent inject represents another major Glaukos milestone in the pursuit of our mission to transform glaucoma therapy and further strengthens our position at the forefront of micro-scale innovation,” said Thomas Burns, Glaukos president and chief executive officer.

“We greatly appreciate the diligent work of the FDA to conduct a thorough and timely review of the iStent inject and grant approval. In addition, we are very grateful to the investigators and patients who participated in the clinical trial and played an instrumental role in helping us to bring iStent inject to the U.S. Given its clinical performance and enhanced procedural elegance, we believe the iStent inject will be an attractive, two-stent solution for U.S. ophthalmic surgeons to reliably manage glaucoma patients’ IOP in a straightforward and effective manner.”

Following the completion of various administrative matters with the FDA, the company intends to commence initial commercial launch activities later in the third quarter.

The iStent inject is already commercially available in the European Union, Armenia, Australia, Brazil, Canada, Hong Kong, Singapore and South Africa, where, in aggregate, more than 30,000 iStent injects have been implanted.

Glaukos pioneered Micro-Invasive Glaucoma Surgery (MIGS). In addition to the iStent inject, the company is currently pursuing FDA approval for four additional MIGS surgical and sustained pharmaceutical therapy pipeline products, all of which are investigational in the U.S., designed to address the full range of glaucoma disease stage and severity.

Glaucoma is characterised by progressive, irreversible and largely asymptomatic vision loss caused by optic nerve damage. There is no cure for the disease and reducing IOP is the only proven treatment. Based on analysis of population-based surveys, medical claims data and other statistics, the company estimates that there are approximately 5.4 million people in the U.S. with primary OAG, the most common form of the disease.