WAVRE, Belgium — 15 March 2023: iSTAR Medical, a medtech company delivering breakthrough eye care solutions to patients, today announced that the first patients have been implanted in its STAR-VI international trial evaluating the safety and efficacy of MINIject® in conjunction with cataract surgery in patients with primary open-angle glaucoma.
iSTAR Medical’s STAR-VI trial is a prospective, interventional, multi-center, single-arm study which seeks to implant a total of 30 patients at up to seven sites in Europe and in Central America. Patients will be followed for two years after their cataract surgery and concurrent MINIject® implantation. The primary endpoint of the trial is to measure the proportion of patients achieving a ≥20% reduction in diurnal intraocular pressure (IOP) from baseline to six-month follow-up, regardless of the use of IOP lowering medication.
MINIject® is iSTAR Medical’s minimally-invasive glaucoma surgery (MIGS) device and is currently the only commercially available supraciliary MIGS implant.
Prof. Iqbal Ike K. Ahmed, Department of Ophthalmology and Visual Sciences, University of Utah (USA), and Chief Innovation Officer, Prism Eye Institute, Ontario (Canada), an investigator in the STAR-VI trial commented:
In the STAR series of trials, iSTAR Medical has established a consistent safety and efficacy profile for standalone use of MINIject in patients with open-angle glaucoma, harnessing the power of the supraciliary space. It is exciting to be involved with this new study, STAR-VI, to assess MINIject’s safety and efficacy also in combination with cataract surgery.
Mr Mahmoud Radwan, Consultant Ophthalmologist at The Colchester Eye Centre, Colchester (UK), an investigator in the STAR-VI trial commented:
It has been estimated[1] that about one in five people undergoing cataract surgery also have glaucoma or ocular hypertension. The ability to treat patients for both cataracts and glaucoma at the same time benefits the patient, the surgeon, the health system as well as society through the efficiency of addressing two major causes of blindness concurrently, and by minimising patient recovery time and cost. I am pleased to be able to take part in the Company’s journey with MINIject to improve the lives of glaucoma patients undergoing cataract surgery.
Michel Vanbrabant, CEO of iSTAR Medical, commented:
The initiation of our global STAR-VI trial is an important step to bring MINIject to more patients around the world, including to those with co-existing ocular conditions. We are committed to delivering our breakthrough eye care solutions to patients globally and look forward to reporting clinical data from this study in due course.
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.
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.[3,4] Invasive surgery can present risks with irreversible complications and often requires long-term patient management.[3,4] MIGS is the most promising and fastest-growing glaucoma therapy due to its enhanced safety profile.[3] MINIject is potentially best-in-class for its promising long-term efficacy and safety.
[1] Leibowitz HM, Krueger DE, Maunder LR, et al. The Framingham Eye Study monograph: An ophthalmological and epidemiological study of cataract, glaucoma, diabetic retinopathy, macular degeneration, and visual acuity in a general population of 2631 adults, 1973-1975. Surv Ophthalmol 1980;24:335–610.
[2] Jonas JB, Aung T, Bourne RR et al. “Glaucoma”. Lancet 2017; 390: 2083–93
[3] Market Scope, “2021 Glaucoma Surgical Device Market Report”, July 2021. https://www.market-scope.com/pages/reports/267/2021-glaucoma-surgical-device-market-report
[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
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