iSTAR Medical Presents Positive Results for MINIject Across Three International Glaucoma Trials

iSTAR Medical presented 2-year safety and efficacy results in a meta-analysis of its STAR-I, STAR-II and STAR-III clinical trials for MINIject at the 15th European Glaucoma Society (EGS) Congress in Athens, Greece. MINIject is the only commercially available supraciliary minimally invasive glaucoma surgery (MIGS) device.

The 2-year results indicated sustained, meaningful efficacy and favorable safety outcomes in patients with primary open-angle glaucoma. In all three trials, MINIject met all endpoints, which included a significant reduction in both IOP as well as hypotensive medication-use. Furthermore, no safety concerns regarding corneal endothelial health were raised across all three trials, a pivotal factor in long-term safety.

Data from the three completed, prospective, open, international, single-arm trials[1] in patients with mild-to-moderate, primary open-angle glaucoma, and whose medication was no longer effective, were pooled in a meta-analysis. MINIject was implanted in a standalone procedure across 11 sites in Central and South America, Asia and Europe.

Results from 66 patients implanted with MINIject across the three trials demonstrated a significant and meaningful 39% reduction in IOP from medicated pre-procedure IOP of 23.8mmHg down to 14.4mmHg at 2-year follow-up. The IOP level and reduction were similar at all semi-annual follow-up visits until 2 years, representing a stable result over time. Additionally, 38% of patients were medication-free at 2 years, and an IOP of ≤18 mmHg was achieved in 85% of patients. MINIject also showed no safety concerns with corneal endothelial health at 2-year follow-up.

MINIject is currently being investigated in iSTAR Medical’s pivotal US trial, STAR-V, where enrollment continues as planned.

“It is highly encouraging to see consistent efficacy and safety results for MINIject in different regions and across three trials," Prof. Dr Antonio Fea, Università degli Studi di Torino, Turin, Italy, and presenter of the data at the 15th EGS Congress, said in a news release. "The supraciliary space has previously been demonstrated to be one of the most efficacious targets for the reduction of eye pressure, and the potential of a new bleb-free MIGS approach with strong efficacy and good safety data represents a highly compelling treatment option for glaucoma patients.” 
 
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