Glaukos Announces FDA Approval of iStent Inject for Lowering IOP

June 29, 2018: By Jon Swedien
Glaukos' iStent Inject

Glaukos’ iStent Inject

Glaukos announced June 25 that its iStent Inject has received US FDA approval.

The trabecular micro-bypass system is indicated for reduction of intraocular pressure (IOP) in adult patients with mild to moderate primary open-angle glaucoma (POAG) who are undergoing cataract surgery.

Glaukos, of San Clemente, California, said it intends to launch the iStent inject in Q3-2018.

The device is designed to help the natural outflow of aqueous humor by creating two bypasses in the trabecular meshwork, which results in multi-directional flow through Schlemm’s canal.

Two heparin-coated titanium stents preloaded into an auto-injection system allow surgeons to implant the stents in two locations through a single corneal entry point.

The iStent Inject is based on the same fluidic method of action as the company’s first-generation pioneering iStent.

Each iStent Inject stent is about 0.23 mm by 0.36 mm—or one-third the size of the first-generation iStent. Glaukos believes the iStent Inject is the smallest medical device ever approved by the FDA.

The iStent Inject is already commercially available in the European Union, Armenia, Australia, Brazil, Canada, Hong Kong, Singapore, and South Africa, and more than 30 thousand iStent Injects have been implanted. The first-generation iStent has been implanted in more than 400 thousand eyes worldwide since its introduction in 2012, Glaukos said.

The iStent Inject’s approval is based on a prospective, randomized, clinical trial at 41 sites that included 505 eyes with mild to moderate POAG. Subjects were randomized to receive the iStent Inject in combination with cataract surgery (n=387) or cataract surgery only (n=118.)

The iStent Inject achieved a statistically significant reduction in unmedicated diurnal IOP in patients undergoing cataract surgery at 24 months, with 75.8 percent of the iStent Inject cohort achieving a 20 percent or greater reduction. Mean unmedicated IOP reduction was 7.0 mmHg for the iStent Inject cohort.

The overall rate of adverse events through 24 months for the iStent Inject cohort was similar to cataract surgery alone.

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