Glaukos’ iStent inject finally wins FDA approval

The iStent inject micro-invasive glaucoma surgery (MIGS) device is now approved for mild to moderate open-angle glaucoma in patients undergoing cataract surgery.

At 0.23 mm by 0.36 mm, the second-generation iStent device is a third of the size of the original iStent and is possibly the smallest FDA-approved medical device to date, according to Glaukos.

Constructed from heparin-coated titanium, the stent is designed to optimize the natural outflow of aqueous humor through the Schlemm’s canal to reduce pressure. The injector comes pre-loaded with 2 stents that allows them to be inserted into multiple trabecular meshwork locations via a single corneal entry point.

“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,” explained Thomas W. Samuelson, MD, a glaucoma surgeon at Minnesota Eye Consultants and an investigator in the iStent inject trial.

The pivotal multicenter trial included 505 participants who were randomized to receive the iStent inject with cataract surgery or cataract surgery only. At 2 years, 75.8% of patients in the iStent group exhibited a 20% or more decrease in unmedicated IOP, compared with 61.9% in the cataract surgery-only group. The device resulted in adverse events similar to those due to cataract surgery alone.

Glaukos is planning a commercial launch in the late third quarter of this year. The device is currently available in Canada, as well as Europe, Armenia, Australia, Brazil, Canada, Hong Kong, Singapore and South Africa.