The supraciliary MIGS device MINIject has demonstrated significant sustained efficacy in treating glaucoma over a five-year period, according to new data presented from the STAR-GLOBAL trial by iSTAR Medical. The results show a maintained 38% reduction in intraocular pressure (IOP) at the five-year mark, reinforcing the device's potential as a long-term treatment option for glaucoma patients.
The data was presented by Andrew Tatham, Consultant Ophthalmologist at Princess Alexandra Eye Pavilion and University of Edinburgh, UK, who also serves as President of the UK and Ireland Glaucoma Society.
Five-Year Efficacy and Safety Data
The STAR-GLOBAL extension trial followed patients from the initial EU clinical trials (STAR I, II, and III) to investigate the long-term performance of MINIject. Of the 56 patients enrolled in the extension, 47 (83.9%) completed the full five-year follow-up period.
Key efficacy findings at the five-year mark include:
- 38% sustained reduction in IOP
- 83% of patients achieved >20% reduction in IOP from baseline
- 80% of patients maintained IOP of 18 mmHg or less
- 32% of patients remained medication-free
The safety profile remained favorable throughout the follow-up period, with no serious adverse events related to the device or procedure reported during the STAR-GLOBAL extension. Importantly, corneal health was confirmed to be maintained at the five-year assessment.
"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," said Dr. Karsten Klabe, Chief Surgeon at Breyer, Kaymak & Klabe Augenchirurgie in Düsseldorf, Germany, and a key investigator in the STAR trials. "This gives us further assurance that MINIject can continue to benefit patients even half a decade post-surgery."
Commercial Progress and Market Position
MINIject is currently the only commercially available supraciliary MIGS implant on the market. Since its launch, more than 5,000 patients have received the implant across various commercial settings globally.
The device combines the porous structure of iSTAR Medical's proprietary STAR material with placement in the supraciliary space. This design aims to enhance natural fluid outflow, reducing IOP and medication needs, while bio-integrating with surrounding tissue to limit inflammation and fibrosis.
Michel Vanbrabant, CEO of iSTAR Medical, emphasized the significance of the results: "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."
Strategic Business Developments
In a significant business update, iSTAR Medical announced the conclusion of its alliance with AbbVie, which was originally established in 2022. The company will now advance MINIject independently, continuing its ongoing US STAR-V trial with plans for FDA submission in 2028.
The company stated it "remains well positioned" to continue the development of MINIject and its commercial roll-out in Europe and other global territories as an independent entity.
Glaucoma Treatment Landscape
Glaucoma affects over 100 million people globally, with primary open-angle glaucoma being the most common form. The progressive disease requires IOP reduction, either through medication or surgery, to delay disease progression.
Traditional treatment typically begins with medication, but this approach often leads to multiple eye drops, resulting in side effects, compliance challenges, and increasing costs for patients. Conventional invasive surgery carries risks of irreversible complications and requires long-term management.
MIGS has emerged as the fastest-growing glaucoma therapy segment due to its enhanced safety profile compared to traditional surgical approaches. With its promising long-term efficacy and safety data, MINIject positions itself as a potential best-in-class option within this growing segment.
Dr. Andrew Tatham noted: "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."
As iSTAR Medical continues to gather clinical evidence and expand its commercial presence, the company aims to establish MINIject as the preferred surgical device among key opinion leaders, physicians, patients, and investors in the glaucoma treatment space.
