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Glaukos' iStent inject receives US FDA approval

04/10/2018
The iStent inject micro-invasive glaucoma surgery (MIGS) device has received pre-market approval from the US Food and Drug Administration (FDA) and 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 optimise the natural outflow of aqueous humor through Schlemm’s canal to reduce pressure. The injector comes pre-loaded with two stents, which allows them to be inserted into multiple trabecular meshwork locations via a single corneal entry point.

The FDA approval is based on the iStent inject US IDE pivotal study, a prospective, multicentre 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).


"It offers them an exciting new treatment option for effectively managing glaucoma patients’ IOP."
Thomas Samuelson, Minnesota eye consultants

The CEO and president of Glaukos, Mr Thomas Burns, said FDA approval represented a major milestone in the pursuit of the company’s “mission to transform glaucoma therapy, and further strengthen our position at the forefront of micro-scale innovation.”

Dr Thomas Samuelson, a glaucoma surgeon at Minnesota Eye Consultants and an investigator in the iStent inject trial, said US ophthalmic surgeons had been eagerly awaiting the availability of iStent inject.

“It offers them an exciting new treatment option for effectively managing glaucoma patients’ IOP while potentially reducing or eliminating the need for topical hypotensive medications,” he explained.

Results from the trial indicated that at two years, 75.8% of patients in the iStent inject group exhibited a 20% or more decrease in un-medicated 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 has been a pioneer of MIGS technology and the iStent inject is already available in the European Union, Australia, Brazil, Canada, Hong Kong, Singapore and South Africa, where, on aggregate, more than 30,000 iStent injects have been implanted.

Following the completion of various administrative matters with the FDA, the company expects to launch the iStent inject in the US before the end of the year.

In addition, 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 US, and designed to address the full range of glaucoma disease stage and severity.



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