iSTAR Medical’s MINIject® demonstrates significant sustained 5-year efficacy in treating glaucoma in STAR-GLOBAL trial

For immediate release

/EIN News/ -- iSTAR Medical’s MINIject^® demonstrates significant sustained 5-year efficacy in treating glaucoma in STAR-GLOBAL trial

• Five-year safety profile including corneal health confirmed and 38% IOP reduction sustained
• Over 5000 patients benefiting from limited commercial rollout of MINIject^® worldwide to-date
• iSTAR Medical to advance MINIject^® independently following ending of AbbVie partnership
  
  

WAVRE, Belgium — 24 April 2025: iSTAR Medical, a medtech company delivering breakthrough eye care solutions to patients, today announces positive five-year data from the STAR-GLOBAL trial for the supraciliary MIGS device, MINIject^®. The data was presented by Andrew Tatham, Consultant Ophthalmologist at Princess Alexandra Eye Pavilion and University of Edinburgh, UK, and President of the UK and Ireland Glaucoma Society.

STAR-GLOBAL is an extension trial of the initial EU clinical trials investigating the long-term safety and efficacy of MINIject^® in patients with up to five-years of follow-up. Patients implanted with the MINIject^® are invited to enroll into STAR-GLOBAL upon completion at two years of an iSTAR Medical clinical trial, to continue follow-up from two to five years.

MINIject^® is currently the only commercially available supraciliary MIGS implant. Since its launch more than 5,000 patients have been implanted across a number of commercial settings and continue to demonstrate meaningful and sustained clinical performance in lowering intraocular pressure (IOP) combined with a favorable safety profile.

Five-year Data from STAR-GLOBAL
Data was obtained from 47 patients in STAR-GLOBAL who completed five-year follow-up from the STAR I, II and III trials (83.9% of the 56 patients enrolled). The efficacy results indicated a sustained and significant 38% reduction of IOP through to five years. Overall, 83% of patients achieved a >20% reduction in IOP from baseline and 80% had IOP of 18 or less at five-year follow-up, with 32% of patients remaining medication free. A favorable safety profile including corneal health was confirmed at five-year follow-up, with no serious adverse events related to the device or procedure in the STAR-GLOBAL follow-up period.

Dr Karsten Klabe, Chief Surgeon at Breyer, Kaymak & Klabe Augenchirurgie, Düsseldorf, Germany, and a key investigator in the STAR trials, commented: “These very positive five-year follow-up results provide further validation of MINIject^® as a safe, standalone procedure and an effective longer-term treatment option for glaucoma patients. This gives us further assurance that MINIject^® can continue to benefit to patients even half a decade post-surgery.”

Andrew Tatham, Consultant Ophthalmologist at Princess Alexandra Eye Pavilion and University of Edinburgh, UK, and President of the UK and Ireland Glaucoma Society said: “This five-year follow-up data is highly encouraging, demonstrating the ability of iSTAR Medical’s MINIject^® to achieve sustained and significant lowering of IOP over the long term. This is consistent with the excellent safety and efficacy profile MINIject^® has already demonstrated in previous STAR trials.”

Michel Vanbrabant, CEO of iSTAR Medical, commented: “The strength and consistency of these five-year results reinforces our belief that MINIject^® has the potential to become the surgical treatment of choice for glaucoma patients, offering a best-in-class solution for long-term glaucoma management. iSTAR Medical remains committed to further validating this hypothesis in its future studies, positioning MINIject^® as the preferred surgical impact device among key opinion leaders, doctors, patients, and investors. With over 5000 patients now implanted, we continue to progress the development of MINIject^® to address a significant unmet need in key global markets.”

Conclusion of Alliance with AbbVie

iSTAR Medical announces that its alliance with AbbVie, announced in 2022, has now ended. iSTAR Medical continues to operate its business as usual as an independent company and remains well positioned to continue the development of MINIject^® in its ongoing US STAR-V trial with the aim of FDA submission in 2028 and the continued commercial roll-out in Europe and other global territories.

– Ends –

For more information

Michel Vanbrabant, Chief Executive Officer, iSTAR Medical
news@istar-medical.com

For media
ICR Healthcare
Amber Fennell, Chris Welsh, Kris Lam
iSTAR@ICRHealthcare.com

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 IOP lowering 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.^1,2 IOP reduction, through medication or surgery, helps delay disease progression.³ Medication is generally the first line treatment, but the progressive addition of multiple drops can burden patients with side effects, compliance challenges and costs.^2,3 Invasive surgery can present risks with irreversible complications and often requires long-term patient management.^2,3 MIGS is the most promising and fastest-growing glaucoma therapy due to its enhanced safety profile.² MINIject^® is potentially best-in-class for its promising long-term efficacy and safety.

¹ Jonas JB, Aung T, Bourne RR et al. "Glaucoma". Lancet 2017; 390: 2083–93
² Market Scope, “2021 Glaucoma Surgical Device Market Report”, July 2021.
³ “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