An unprecedented 200 peer-reviewed publications have now highlighted the efficacy and safety of iStent technologies around the world. According to Glaukos, this achievement represents the largest, most diverse and longest-term body of clinical data for any MIGS procedure.
Highlights of the clinical evidence include:
- Over 20,000 eyes analysed in a wide range of studies over nearly 20 years,
- 183 publications detailed independently conducted, investigator-initiated studies,
- 11 studies were prospective, randomised, controlled trials (RCTs),
- More than 50 of the publications highlighted studies in a standalone glaucoma patient population, with 20 meta-analyses and 14 cost-effectiveness studies demonstrating payor and practice efficiency,
- 15 publications analysed four to eight-year outcomes data, establishing the largest and longest-term follow-up of any MIGS procedure,
- Published independent research from more than 20 countries demonstrated efficacy and safety in highly diverse patient populations with varying degrees of glaucoma (ocular hypertension through advanced/refractory disease), and
- The first and only MIGS procedure to demonstrate improved patient quality of life from a pivotal trial.
Additionally, the official publication of the World Glaucoma Association, the Journal of Glaucoma, selected a study on iStent and iStent inject 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 analysed to evaluate the independent effect of iStent and iStent inject without cataract surgery, including four randomised controlled trials and nine non-randomised (single-arm) studies providing data on 778 eyes. In eyes implanted with iStent devices, a weighted mean intraocular pressure (IOP) reduction of 31.1% was observed at six to 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 six to 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 six to 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 organisation, 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 focussed 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 revolutionised the way we treat glaucoma today,” said Dr Thomas W Samuelson, Surgeon at Minnesota Eye Consultants, and Adjunct Professor at the University of Minnesota. “Glaukos has been focussed on generating high-quality clinical evidence to support the uptake of MIGS procedures since day one and has continued to do so over the last 20 years. I am looking forward to Glaukos’ continued innovation and exciting new product launches ahead.”
Dr Ike Ahmed, Research Director at the Kensington Eye Institute and Director of the Glaucoma and Advanced Anterior Segment Surgery Fellowship Program at the University of Toronto said, “Each evolution, from iStent to iStent inject and now to iStent inject W, has been a transition to making the procedure more predictable and effective… In my practice, iStent and iStent inject clinical outcomes have stood the test of time as I routinely see patients over 10 years post-iStent surgery whose glaucoma is still well-managed. The high safety and versatility of iStent technologies make this our most commonly used MIGS procedure in mild-moderate open-angle glaucoma.”
With a commitment to innovation, Glaukos continues to invest upwards of 30% of revenue back into research and development, including new product development. A significant number of clinical studies for both current and future products are ongoing, with additional studies commencing in the near future.