Glaukos has claimed a series of regulatory clearances in Europe for its micro-scale surgical implants to treat patients with glaucoma, expanding the company’s reach overseas.
The green lights under the EU’s MDR certification process cover Glaukos’ iStent platform. That includes iStent infinite, a miniature bypass device that’s placed around the edges of the eye to allow fluids to flow outward and reduce intraocular pressure, as well as the iStent inject W, a similar implant that can be placed during cataract surgery.
The California-based company said the approvals were its first under the EU’s new and more-stringent regulatory pathway.
“These important milestones will not only help us maintain and grow our presence in Europe but also advance and accelerate our broader Interventional glaucoma initiatives globally,” Glaukos CEO Thomas Burns said in a statement. “We are eager to commence commercial launch activities for these novel [micro-invasive glaucoma surgery] therapies over the coming months.”
Glaukos most recently obtained a U.S. approval for iStent infinite in 2022, opening up its use as a standalone procedure for patients who have not seen benefits from other drug therapies or surgical treatments. The system includes three heparin-coated titanium stents, each about a third of a millimeter in size, preloaded in an autoinjector.
In clinical trials, the micro-bypass implants lowered average intraocular pressure readings by 20% or more in about three-quarters of patients after one year, while patients maintained their medication regimen or took fewer drugs.
Currently, the company is working on a new clinical study for iStent Infinite, aimed at obtaining a new premarket approval from the FDA that would expand its indications to mild to moderate glaucoma.