■ iSTAR Medical has announced positive results from 2 clinical trials of its microinvasive glaucoma surgery (MIGS) implant MINIject. Both studies showed consistently significant reduction of IOP and reduced need for IOP-lowering medication in more than 50 patients with open-angle glaucoma, following standalone MINIject implantation. Two-year final outcomes from iSTAR Medical’s STAR-I trial and 6-month results from its European trial STAR-II have been accepted for presentation at the European Glaucoma Society meeting.
The mean reduction in IOP in patients implanted with MINIject in STAR-I remained consistent around 40% throughout the study. Moreover, nearly half of the patients were medication free at trial conclusion with a mean reduction of nearly 1 (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 2 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,” said Ike Ahmed, MD, of the University of Toronto.
“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,” Dr. Ahmed added.
In the STAR-II study, a total of 29 patients have been implanted with MINIject in 8 European centers and will be followed up for 2 years. The mean reduction in IOP in these patients was 40%, with 55% of patients on no medication at 6 months. The trial met its primary endpoint by far exceeding the predefined success rate at 6 months. More than 75% of patients achieved diurnal IOP between 5 mmHg and 21 mmHg, with at least 20% percent IOP reduction from baseline. A mean reduction of nearly 2 (1.8) IOP-lowering medications was achieved. Minimal reduction in ECD was observed.
“The IOP reduction seen in the 6-month STAR-II European trial data is substantial, considering that it results from a standalone procedure rather than from joint intervention with cataract surgery, which may augment the outcomes,” stated Prof Philippe Denis, head of the Department of Ophthalmology, Hôpital de la Croix-Rousse, Lyon, France, and a STAR-II trial investigator.
“The STAR-II results are consistent with 6-month STAR-I data,” Professor Denis explained. “Most STAR-II patients were medication free after 6 months, which over time would help improve quality of life and reduce side-effects from medication use,” he added.
MINIject’s biocompatible, soft and flexible material is designed to conform to the eye anatomy and to enable biointegration of the surrounding tissue. This sustains natural flow and drainage by minimizing fibrosis, iSTAR says. Implantation is a single-step procedure.