The trial is for the MINIject MIGS device for patients with primary open-angle glaucoma.
iStar Medical has announced positive 3-year results from the STAR-GLOBAL trial for the MINIject® in open-angle glaucoma patients.
According to a press release from iStar, the STAR-GLOBAL trial is an extension trial investigating the long-term safety and efficacy of patients up to 5-years of follow-up.1
MINIject® is iStar Medical’s innovative MIGS device for patients with primary open-angle glaucoma. According to iStar, 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.1
iStar reported the interim data from 48 patients in the STAR-GLOBAL trial who completed 3-year follow-up during the iStar Medical symposium at the World Glaucoma Congress (WGC) in Rome, Italy.
The efficacy results indicate a sustained, meaningful 36% reduction of eye pressure at 3 years with 42% of patients being medication-free, according to data from the press release. A favorable safety profile including corneal health was confirmed at 3-year follow-up, with no serious adverse events related to the device or procedure in the STAR-GLOBAL follow-up period.1
Inder Paul Singh, MD, MPH, glaucoma specialist and president of the Eye Centers of Racine & Kenosha said about the results, “The safety and efficacy observed at up to three-year follow-up is highly encouraging as it demonstrates the sustained and meaningful performance of iSTAR Medical’s MINIject® into the longer term. This confirms the consistent safety and efficacy profile MINIject has already shown in previous STAR trials.”
In the press release, the CEO of iStar Michel Vanbrabant talked about the trial saying; “These data from our ongoing STAR-GLOBAL trial further validate MINIject’s safety and efficacy as a supraciliary MIGS implant to reduce eye pressure in open-angle glaucoma patients. These positive STAR-GLOBAL follow-up data strengthen the evidence for MINIject® as a safe, standalone procedure and a promising treatment option for glaucoma patients in the longer-term, meaning patients can be assured that MINIject® remains safe and effective several years after surgery.”