Glaukos nets FDA clearance for latest pressure-relieving glaucoma eye stent

Glaukos secured a new FDA clearance for its miniaturized stent system designed for glaucoma to help drain the inner eye of built-up fluids and normalize intraocular pressure.

The company had received the agency’s blessing for previous versions of its injectable iStent, but it could only be deployed while patients were already undergoing surgery to replace a cataract lens. 

But now the latest green light opens up the use of Glaukos’ iStent Infinite through its own, standalone procedure—giving eye surgeons a greater range of options to treat elevated intraocular pressure and help prevent loss of vision among patients where other drugs or surgical treatments have failed.

In clinical trials, the iStent Infinite micro-bypass implant lowered average pressure readings by 20% or more in about three-quarters of treated patients after one year. According to Glaukos, Patients who saw benefits did so while taking their same medication regimen or fewer drugs, and more than half the participants saw pressure reductions of 30% or more after 12 months.

The iStent Infinite system includes three heparin-coated titanium stents, each about a third of a millimeter in size, that come preloaded in an autoinjector. They are placed in an arc around the edge of the eye, restoring the connection between the fluid-filled interior of the eye and its main drainage channels.

The company’s previously cleared iStent Inject W system relied on two similarly micro-invasive stents to support postoperative care following cataract surgery. Glaukos said it plans to begin iStent Infinite’s initial commercial launch later this year.

Glaukos also posted its second-quarter earnings, listing total net sales of $72.7 million, including $56.1 million from its glaucoma products. That was a 7% drop compared to the $78.0 million seen in the same period last year.

With about $91.6 million in operating costs plus other expenses, the company reported a net loss of $45.5 million, a big jump over the $17.4 million loss it saw in 2021’s second quarter. Part of that was driven by a 31% increase in R&D expenses, as well as 10% growth in selling, general and administrative costs, the company said. Glaukos forecasted its total 2022 net sales to fall within the range of $275 million to $280 million.