Glaukos Announces Clinical Milestone of 200 Peer-Reviewed Publications on iStent Technologies

Glaukos announced a clinical data milestone of 200 peer-reviewed publications highlighting the efficacy and safety of iStent technologies around the world. This achievement represents the largest, most diverse and longest-term body of clinical data for any MIGS procedure, according to Glaukos. Several points of note in this market-leading body of clinical evidence include:

• Over 20,000 eyes have been analyzed in a wide range of studies over nearly 20 years.
• 183 publications detail independently conducted, investigator-initiated studies.
• 11 studies are prospective, randomized, controlled trials (RCTs).
• More than 50 of the publications highlight studies in a standalone glaucoma patient population, with 20 meta-analyses and 14 cost-effectiveness studies demonstrating payor and practice efficiency.
• 15 publications analyze 4- to 8-year outcomes data, establishing the largest and longest-term follow up of any MIGS procedure.
• Independent research from more than 20 countries has been published, demonstrating efficacy and safety in highly diverse patient populations with varying degrees of glaucoma (ocular hypertension through advanced/refractory disease).
• First and only MIGS procedure to demonstrate improved patient quality of life from a pivotal trial.

In addition, the official publication of the World Glaucoma Association, the Journal of Glaucoma, selected a study on iStent and iStentinject as its July 2021 Paper of the Month. In this systematic review and meta-analysis authored by Dr. Paul Healey, a total of 13 studies were analyzed to evaluate the independent effect of iStent and iStent inject without cataract surgery, including four randomized controlled trials and nine non-randomized (single-arm) studies providing data on 778 eyes. In eyes implanted with iStent devices, a weighted mean IOP reduction of 31.1% was observed at 6-12 months. In studies reporting longer-term outcomes, the weighted mean IOP reduction was 30.4% and 32.9% at 36-48 months and 60 months, respectively. The pooled weighted mean IOP reduction from baseline across all studies at 6-12 months and 36-60 months post-stent implantation was 7.0 mmHg and 6.6 mmHg, respectively. Medication burden was reduced by approximately 1.0 medication at 6-18 months, and by 1.2 medications at 36-60 months.

“Since the inception of Glaukos Corporation, our goal has been to transform the treatment of chronic, debilitating eye diseases through development of novel, sustainable therapies,” said Thomas Burns, Glaukos president and chief executive officer. “Scientific evidence and clinical rigor have been at the heart of our organization, with the earliest publication on iStent for the treatment of glaucoma dating back to 2002, two years prior to the initiation of the original iStent pivotal trial. Nearly 20 years later, we apply this same rigor and integrity to our business as we remain focused on generating strong clinical evidence, demonstrated by this trailblazing accomplishment of 200 peer-reviewed publications. I am grateful for our customers and employees around the world who have poured countless hours into this market-leading achievement to support our iStent technologies for the benefit of patients worldwide.”

“As one of the early adopters and investigators in the original iStent pivotal trial, I have experienced first-hand how iStent, as the first MIGS device, has fundamentally revolutionized the way we treat glaucoma today,” said Thomas W. Samuelson, MD, surgeon at Minnesota Eye Consultants, and Adjunct Professor at the University of Minnesota. “Glaukos has been focused on generating high-quality clinical evidence to support the uptake of MIGS procedures since day 1 and has continued to do so over the last 20 years. I am looking forward to Glaukos’s continued innovation and exciting new product launches ahead.”