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

FDA device

The US FDA’s Center for Devices and Radiological Health. (Credit: The U.S. Food and Drug Administration)

Glaukos Corporation (NYSE: GKOS), an ophthalmic medical technology and pharmaceutical company focused on novel therapies for the treatment of glaucoma, corneal disorders and retinal diseases, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the iPRIMEViscodelivery System, a sterile, single-use, minimally-invasive device for the delivery of viscoelastic fluid during ophthalmic surgery.

“Since the introduction of our first iStent® Trabecular Micro-Bypass Stent in 2012, Glaukos has pioneered the MIGS marketplace and led a transformation in the way ophthalmic surgeons manage chronic eye diseases. We are thrilled to announce this clearance as we believe iPRIME will be another important tool that supports the needs of physicians and patients,” said Thomas Burns, Glaukos president and chief executive officer.

“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.”

Glaukos (www.glaukos.com) is an ophthalmic medical technology and pharmaceutical company focused on novel therapies for the treatment of glaucoma, corneal disorders and retinal diseases. The company pioneered Micro-Invasive Glaucoma Surgery, or MIGS, to revolutionize the traditional glaucoma treatment and management paradigm.

Glaukos launched the iStent®, its first MIGS device, in the United States in 2012, its next-generation iStent inject® device in the United States in 2018, and most recently, the iStent inject W device in 2020.

Source: Company Press Release