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Glaukos submits premarket approval for iStent inject

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Glaukos has submitted a premarket approval application to the FDA for its iStent inject trabecular micro-bypass stent, according to a company press release.

The iStent inject, designed to improve aqueous humor outflow into Schlemm’s canal and reduce IOP in patients with open-angle glaucoma undergoing cataract surgery, includes two heparin-coated titanium stents preloaded into an auto-injection system. Surgeons can inject the stents into multiple trabecular meshwork locations through a single corneal entry point, the release said.

In a prospective clinical trial of 505 subjects randomized to receive either cataract surgery alone or cataract surgery combined with the iStent inject, IOP was reduced 20% or greater from baseline at 24 months in the combination arm, thus reaching the primary effectiveness endpoint, according to the company, which plans to release efficacy and safety data from the trial in the first half of 2018.

The iStent inject is currently approved in the European Union, Armenia, Australia, Brazil, Canada, Hong Kong, Singapore and South Africa, the release said.