Belgium-based med-tech firm iSTAR Medical SA has announced promising results from two clinical trials (STAR-I and STAR-II). The trials were for MINIject, a biocompatible minimally-invasive glaucoma surgery (MIGS) implant. 

The trial findings showed significant reductions in both eye pressure and the need for pressure-lowering medications in patients with open-angle glaucoma.*

STAR-I 

Results of the STAR-I trial showed:

• There was a mean reduction of about 40% in intraocular pressure (IOP) in patients implanted with the MINIject in STAR-I, which remained consistent for the duration of the study.
• Nearly half of the participants were medication-free at the trial’s conclusion, with minimal reduction in corneal endothelial cell density (ECD). (Endothelial cells are necessary for corneal hydration.)

“The final results of the STAR-I trial for MINIject two years after standalone implantation are particularly promising,” said Dr. Ike Ahmed of the University of Toronto and a leading MIGS authority, “because they show both significant, sustained IOP reduction, and a large number of medication-free patients longer-term.” 

STAR-II

For the STAR-II trial, 29 patients in eight centers across France, Germany, and Spain have received the MINIject implant. 

So far, the six-month follow-up results show:

• A mean IOP reduction of 40%, with 55% of patients on no medication at six months
• A mean reduction of nearly two IOP-reducing medications
• A minimal reduction of ECD

Additionally, more than 75% of patients have achieved a daytime IOP between 5 and 21mmHg, with at least a 20% IOP reduction from baseline. This exceeds the predefined six-month success rate.

“The IOP reduction seen in the six-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,” said Philippe Denis, head of the Department of Ophthalmology, Hôpital de la Croix-Rousse, Lyon, France, and a STAR-II trial investigator.”  

The trial will conclude after a total of two years.

What makes the MINIject implant special?

iSTAR Medical holds the exclusive rights for ophthalmic use of the STAR® biomaterial—a micro-porous, medical-grade silicone developed by the University of Washington in Seattle. Using this material as a foundation, iStar created MINIject as the first truly biocompatible device to treat glaucoma. 

The implant’s soft, flexible substance:

• Conforms to the eye’s anatomy
• Enables biological integration of surrounding tissue
• Sustains natural flow and drainage by minimizing fibrosis (formation of scar tissue)

The implantation procedure requires only one step, making it quick and simple to perform and reducing the risk of complications.

“Our unique proposition is delivering outstanding performance in IOP and medication reduction over time to minimise disease progression and improve quality of life for patients with a minimally invasive device,” said iSTAR Medical CEO Michel Vanbrabant.

*iStar Medical. (2020, Apr. 24). First Truly Biocompatible MIGS Implant from iSTAR Medical Shows Consistently Outstanding Efficacy in Patients with Glaucoma [Press Release]. https://www.istarmed.com/us/2020/04/29/first-truly-biocompatible-migs-implant-from-istar-medical-shows-consistently-outstanding-efficacy-in-patients-with-glaucoma/