Glaukos’ iPRIME Delivery System Wins FDA Nod

Ophthalmic tech and pharmaceutical company Glaukos has earned U.S. Food and Drug Administration (FDA) 510(k) clearance for its iPRIME Viscodelivery System, a sterile, single-use minimally invasive viscoelastic fluid delivery device for 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,” Thomas Burns, Glaukos president and CEO told the press. “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. “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 pioneered mirco-invasive glaucoma surgery (MIGS) launching its first MIGS device—iStent—in ths U.S. in 2012. The next-generation iStent inject followed in 2018, also released in the U.S. Most recently, the iStent inject W hit the market in 2020. Glaukos’ suite of pharmaceuticals strengthen, stabilize, and reshape the cornea using corneal collagen cross-linked to treat corneal ectatic disorders and correct refractive conditions.