iSTAR Medical SA last week announced positive results from two clinical trials of its micro-invasive glaucoma surgery (MIGS) implant MINIject. Both studies showed a consistent reduction of intraocular pressure (IOP) and reduced need for IOP-lowering medication in over 50 patients with open-angle glaucoma, following standalone MINIject implantation.
MINIject is a biocompatible MIGS implant for the treatment of glaucoma. It utilizes a soft and flexible, medical-grade silicone with a micro-porous, multi-channel geometry to conform to the eye and integrate with the surrounding tissue. Its design enables a natural flow speed, reducing the incidence of fibrosis and minimising scarring. Implantation is a quick, single-step procedure.
Two-year final outcomes from iSTAR Medical’s STAR-I trial and six-month results from its European trial STAR-II have been accepted for presentation at the European Glaucoma Society (EGS) meeting, now postponed to December 2020 following the Covid-19 pandemic.
The STAR-I trial
The mean reduction in IOP in patients implanted with MINIject in STAR-I remained consistent around 40 percent throughout the study. Moreover, nearly half of the patients were medication-free at trial conclusion with a mean reduction of nearly one (0.8) IOP-lowering medication. A minimal reduction in corneal endothelial cell density (ECD) was observed.
“The final results of the STAR-I trial for MINIject two years after standalone implantation are particularly promising because they show both significant, sustained IOP reduction, and a large number of medication-free patients longer-term”, commented Doctor Ike Ahmed, University of Toronto, a global leading authority in MIGS. “The iSTAR Medical truly biocompatible MIGS device enhances natural aqueous humour flow through the supraciliary space, which promises to be a reliable and safe approach for the treatment of patients with glaucoma.”
The STAR-II EU trial
A total of 29 patients have been implanted with MINIject in eight European centres in France, Germany and Spain as part of the STAR-II trial and will be followed-up for two years.
The trial met its primary endpoint by far exceeding the pre-defined success rate at six months. The mean reduction in IOP in these patients was 40 percent, with 55 percent of patients on no medication at six months. Over 75 percent of patients achieved diurnal IOP between 5 and 21mmHg with at least 20 percent IOP reduction from baseline. A mean reduction of nearly two (1.8) IOP-lowering medications was achieved. Minimal reduction in ECD was observed.
Full news release: https://www.istarmed.com/2020/04/29/first-truly-biocompatible-migs-implant-from-istar-medical-shows-consistently-outstanding-efficacy-in-patients-with-glaucoma/