iStar Medical Announces Positive 5-year Results of MINIject® in Glaucoma Patients

iStar Medical has announced positive 5-year results from the STAR-GLOBAL trial for their MINIject®device in patients with open-angle glaucoma. 

STAR-GLOBAL is an extension trial investigating the long-term safety and efficacy of MINIject® up to five years after implantation. MINIject® is currently the only commercially available supraciliary MIGS implant, designed to enhance natural fluid outflow and reduce intraocular pressure (IOP).

According to iStar’s press release, MINIject® demonstrated a sustained and significant 38% reduction in IOP at 5 years of follow-up. The study included 47 participants, of which 83% achieved a >20% reduction in IOP from baseline and 80% had IOP of 18 or less at five-year follow-up. 32% of patients did not require topical medications for IOP control. iStar also reports a favorable safety profile with no adverse events during the study period. 

“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,” Dr Karsten Klabe, Chief Surgeon at Breyer, Kaymak & Klabe Augenchirurgie, Düsseldorf, Germany, and a key investigator in the STAR trials, said in a recent press release. “This gives us further assurance that MINIject® can continue to benefit to patients even half a decade post-surgery.”

Michel Vanbrabant, CEO of iSTAR Medical, also shared his confidence in MINIject® as an optimal treatment option for long-term glaucoma management based on these results. “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.”

iStar Medical also announced that their partnership with AbbVie, which began in 2022, has ended. The company now operates independently. They remain on track for the continued commercial roll-out in Europe and aim to apply for U.S. FDA approval in 2028.