A new micro-surgical device from Glaukos Corp. has received clearance from the Food and Drug Administration.
The $2.5 billion-valued ophthalmic device and drugmaker in San Clemente (NYSE: GKOS) announced in January that its iPrime Viscodelivery System received a 510(k) clearance, or a pre-market notification, from the agency.
“We are thrilled to announce this clearance as we believe iPrime will be another important tool that supports the needs of physicians and patients,” Glaukos’ Chief Executive Thomas Burns said in a statement. “This technology further expands Glaukos’ broad portfolio of innovative ophthalmic solutions and is consistent with our longstanding position on the value of truly minimally invasive
therapy.”
The iPrime is a single-use, minimally invasive device designed to deliver “viscoelastic fluid” during eye surgery, the company said.
Viscoelastic fluid, a portmanteau of “viscous” and “elastic,” is a fluid ophthalmic surgeons use to prevent a patient’s eye from collapsing when making an incision.
According to healthcare journal Market-Scope, the iPrime appears to be designed to thread, or microcatheterize, the Schlemm’s canal of the eye and then use viscoelastic to flush and dilate the canal in a procedure called canaloplasty.
The company did not indicate when the system would be available for surgical use, nor its price.
MIGS ‘Pioneer’
Glaukos, founded in 1998, is an ophthalmic company focused on devices and drugs to treat glaucoma, corneal disorders and retinal diseases. It’s best-known for its eye stents, which are among the smallest medical devices ever made.
Since Glaukos’ inception, it has become the “pioneer” of micro-invasive glaucoma surgery, or MIGS, according to Burns.
The FDA approved the company’s first MIGS device, the iStent Trabecular Micro-Bypass in 2012 and approved its second-generation iStent in 2018.
Today, Glaukos counts three FDA-approved micro-invasive glaucoma surgery (MIGS) devices: the iStent, the iStent inject, and the iStent inject W.
The company has 15 candidates in its total product pipeline, with “additional undisclosed programs” in its total product pipeline, per Glaukos’ website.
The iPrime is Glaukos’ latest candidate to receive FDA clearance.
In 2018, Glaukos announced plans to move into a three-building, 160,000-square-foot facility in Aliso Viejo, representing the largest office lease in Orange County that year. However, the headquarters relocation has yet to take place, due in part to pandemic-related delays.
The company’s stock is up about 18% this year. Shares are still down about a third since July when it was revealed the Centers for Medicare and Medicaid Services had slashed prices for a key Glaukos product.
The company plans to release fourth quarter and full year 2021 financial results after the market closes on Feb. 22.
