iSTAR Medical, a medtech company developing minimally invasive ophthalmic implants for the treatment of patients with glaucoma, said its minimally invasive glaucoma surgery (MIGS) device MINIject showed consistently positive safety and efficacy outcomes in a larger patient population from the STAR-1 and STAR-2 trials. A pooled analysis reviewed data from more than 130 patients implanted with MINIject in the supraciliary space in standalone procedures across 11 trial sites in Europe, the Americas, and Asia.

According to the pooled data analysis, only 5% of patients implanted with MINIject have required secondary glaucoma surgery to date. Considering that a third of patients have already completed 18- and 24-month follow-ups, the reintervention rate is very low compared to standalone trials for other MIGS devices. Minimizing the number of repeat surgical interventions for glaucoma while preventing disease progression may help to improve visual function and quality of life at a sustainable personal and financial cost, which are key patient management goals over the long term.

Moreover, mean central corneal endothelial cell density (ECD) loss at 6 months was only 2%, and there was no occurrence of ECD loss greater than 30% in patients analyzed per protocol from all MINIject trials followed up at 6 months. In patients from the STAR-I trial, which concluded at 2 years, mean ECD loss remained low (5%), with no patients having ECD loss greater than 30% at study completion. High ECD loss levels can cause corneal edema and loss of transparency, which disrupt vision.

One-year follow-up data were also announced for the European STAR-2 trial. At 1 year, mean IOP was 15.1 mmHg, corresponding to a 38% reduction from medicated baseline IOP. Moreover, 45% of patients did not require any IOP-lowering medication 1 year after intervention (from a mean of 2.9 medications at baseline). In a post-hoc analysis in medication-free patients, IOP was reduced further by 46%t to 13.1 mmHg at 1 year. There were no significant overall safety issues or concerns with corneal health.