WAVRE, Belgium — 8 June 2022: iSTAR Medical, a medtech company delivering breakthrough eye care solutions to patients, presented two-year safety and efficacy results in a meta-analysis of its STAR-I, STAR-II and STAR-III clinical trials for MINIject® at the 15th European Glaucoma Society (EGS) Congress in Athens. MINIject® is the only commercially available supraciliary minimally invasive glaucoma surgery (MIGS) device.
The two-year results indicated sustained, meaningful efficacy and favourable safety outcomes in patients with primary open-angle glaucoma. In all three trials, MINIject® met all endpoints, which included a significant reduction in both intraocular pressure (IOP) as well as hypotensive medication-use. Furthermore, no safety concerns regarding corneal endothelial health were raised across all three trials, a pivotal factor in long-term safety.
Data from the three completed, prospective, open, international, single-arm trials[1] in patients with mild-to-moderate, primary open-angle glaucoma, and whose medication was no longer effective, were pooled in a meta-analysis. MINIject® was implanted in a standalone procedure across 11 sites in Central and South America, Asia and Europe.
Results from 66 patients implanted with MINIject® across the three trials demonstrated a significant and meaningful 39% reduction in IOP from medicated pre-procedure IOP of 23.8mmHg down to 14.4mmHg at two-year follow-up. The IOP level and reduction were similar at all semi-annual follow-up visits until two years, representing a stable result over time. Additionally, 38% of patients were medication-free at two years, and an IOP of ≤18 mmHg was achieved in 85% of patients. MINIject® also showed no safety concerns with corneal endothelial health at two-year follow-up.
MINIject® is currently being investigated in iSTAR Medical’s pivotal US trial, STAR-V, where enrollment continues as planned.
Prof. Dr Antonio Fea, Università degli Studi di Torino, Turin, Italy, and presenter of the data at the 15th EGS Congress, said:
“It is highly encouraging to see consistent efficacy and safety results for MINIject in different regions and across three trials. The supraciliary space has previously been demonstrated to be one of the most efficacious targets for the reduction of eye pressure, and the potential of a new bleb-free MIGS approach with strong efficacy and good safety data represents a highly compelling treatment option for glaucoma patients.”
Michel Vanbrabant, CEO of iSTAR Medical, commented:
“This meta-analysis of our three STAR trials at two years has clearly strengthened the growing evidence for MINIject as a safe, standalone procedure. With all endpoints met, the results demonstrate MINIject’s meaningful and stable efficacy over a two-year follow-up period in a sizeable patient population spanning several regions throughout the world, and without compromising patient safety. We look forward to providing further supporting safety and efficacy data from the long-term, follow-up trial, STAR-GLOBAL.”
About iSTAR Medical
iSTAR Medical is committed to delivering breakthrough eye care solutions. Our most advanced product, MINIject®, is approved in Europe for the treatment of open-angle glaucoma – the leading cause of irreversible blindness – and we are aiming to seek market approval in the US. We believe MINIject®’s distinctive tissue-integrating capabilities unlock a safer, and more effective option for patients. We are building an exceptional team and pipeline of potentially leading products such as MINIject® to establish new treatment paradigms in eye care conditions with the highest patient needs. For more information, please visit: www.istar-medical.com
About MINIject®
MINIject® is iSTAR Medical’s innovative MIGS device for patients with primary open-angle glaucoma. MINIject® combines the distinctive porous structure of its proprietary STAR material with the power offered by the supraciliary space. As a result, it is designed to enhance natural fluid outflow, reducing intraocular pressure (IOP) and the need for medication, while bio-integrating with surrounding tissue, limiting inflammation, fibrosis and subsequent complications.
About Glaucoma
Glaucoma is a progressive disease affecting over 100 million people globally, of which primary open-angle glaucoma is the most common form.[2][3] IOP reduction, through medication or surgery, helps delay disease progression.[4] Medication is generally the first line treatment, but the progressive addition of multiple drops can burden patients with side effects, compliance challenges and costs.[2][4] Invasive surgery can present risks with irreversible complications and often requires long-term patient management.[2][4] MIGS is the most promising and fastest-growing glaucoma therapy due to its enhanced safety profile.[2] We believe MINIject® may become a leading MIGS device with its promising long-term efficacy and safety.
[1] STAR-I: NCT03193736, STAR-II: NCT03624361, STAR-III: NCT03996200 on clinicaltrials.gov
[2] Market Scope, “2021 Glaucoma Surgical Device Market Report”, July 2021. https://www.market-scope.com/pages/reports/267/2021-glaucoma-surgical-device-market-report
[3] Jonas JB, Aung T, Bourne RR et al. “Glaucoma”. Lancet 2017; 390: 2083–93
[4] “European Glaucoma Society Terminology and Guidelines for Glaucoma”, 4th Edition: British Journal of Ophthalmology. 2017;101:1-195 https://bjo.bmj.com/content/101/5/73
EN
