iSTAR Medical’s MINIject® Exhibits Remarkable Long-Term Impact in Glaucoma Management
For immediate release
iSTAR Medical’s MINIject demonstrates significant sustained 5-year efficacy in treating glaucoma in STAR-GLOBAL trial
iSTAR Medical, a cutting-edge medtech company committed to improving eye care solutions for patients, has shared compelling five-year data from the STAR-GLOBAL trial for their innovative supraciliary MIGS device, MINIject®. This information was presented by Andrew Tatham, a Consultant Ophthalmologist, emphasizing its groundbreaking potential in the treatment landscape for glaucoma.
The STAR-GLOBAL trial extends the initial EU clinical trials that focused on the long-term effects had by MINIject® in patients, who follow-up for up to five years to ascertain sustained safety and efficacy. This trial represents an essential step in securing robust evidence of the device's performance and reliability in the field.
MINIject® stands out as the only commercially available supraciliary MIGS implant, promising significant advancements in patient outcomes. Since its launch, over 5,000 patients have been successfully treated with the device, indicating meaningful and sustained clinical effectiveness in lowering intraocular pressure (IOP) alongside a reassuring safety profile.
Five-Year Insights from the STAR-GLOBAL Trial
The efficacy results derived from STAR-GLOBAL are striking. Data from 47 patients who completed five years of follow-up from prior trials indicated a consistent and significant reduction in IOP by an impressive 38%. Furthermore, 83% of these patients experienced over a 20% drop in IOP from baseline measurements, and 80% achieved an IOP level of 18 or lower at the five-year mark, with a noteworthy 32% of those patients remaining medication-free.
The five-year follow-up confirmed a favorable safety profile, particularly regarding corneal health, with no serious adverse events related to the device or procedure reported. These findings provide strong evidence that MINIject® can be a reliable solution for patients managing glaucoma.
Expert Commentary on MINIject®
Dr. Karsten Klabe, Chief Surgeon at Breyer, Kaymak & Klabe Augenchirurgie, Düsseldorf, and a pivotal researcher in the STAR trials, voiced a positive outlook: “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 patients even half a decade post-surgery.”
Andrew Tatham echoed these sentiments, highlighting the significant lowering of IOP that can be continuously achieved by MINIject®. He pointed out that these findings align seamlessly with the safety and efficacy profile established in previous trials.
Committed to Advancing Glaucoma Treatment
Michel Vanbrabant, CEO of iSTAR Medical, expressed optimism, stating: “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.”
Despite the recent conclusion of its partnership with AbbVie, iSTAR Medical continues its mission as an independent entity, focusing on advancing its products, including MINIject®. The company is currently progressing its US STAR-V trial with a targeted FDA submission aimed for 2028 while expanding its commercial rollout in Europe and other strategic global markets.
Understanding the Need for Innovative Solutions in Glaucoma Care
Glaucoma is a critical eye condition affecting over 100 million people worldwide, with primary open-angle glaucoma being the most prevalent type. Lowering IOP through various treatments is vital for delaying disease progression. Traditional medications often pose challenges such as side effects and insufficient compliance, not to mention the risks associated with invasive surgeries. iSTAR Medical's MINIject® offers an enhanced safety profile and significant long-term efficacy, demonstrating the promise of MIGS technology in addressing the ever-increasing demand for effective glaucoma solutions.
Frequently Asked Questions
What is MINIject® and how does it work?
MINIject® is an innovative minimally invasive glaucoma surgery (MIGS) device that reduces intraocular pressure by enhancing the natural outflow of fluids in the eye.
What are the results from the STAR-GLOBAL trial?
The trial showed a sustained reduction in intraocular pressure of 38% over five years, with a majority of patients achieving significant improvements while maintaining favorable safety profiles.
How many patients have been treated with MINIject® to date?
Over time, more than 5,000 patients have successfully been treated with MINIject® worldwide.
What is the future of iSTAR Medical after its partnership with AbbVie?
iSTAR Medical continues as an independent company, focusing on advancing MINIject® and expanding its presence in the global market, including ongoing clinical trials in the US.
Why is effective glaucoma treatment important?
Effective glaucoma treatment is crucial as it helps preserve vision and manage intraocular pressure, reducing the risk of irreversible blindness for millions of affected individuals.
