iStar Medical announced positive one-year results from the European STAR-II clinical trial of its micro-invasive glaucoma surgery (MIGS) device, MINIjectTM. The results have been presented at the virtual American Academy of Ophthalmology (AAO) annual meeting, held 13-15 November 2020.
STAR-II results at one year
At one-year follow-up, mean intraocular pressure (IOP) was 15.1 mm Hg, corresponding to a 38 percent reduction from medicated baseline IOP. Moreover, 45 percent of patients did not require any IOP-lowering medication one 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 percent to 13.1 mm Hg at one year. There were no significant overall safety issues, nor concerns with corneal health.
“The STAR-II results at one year confirm MINIject is a remarkably effective treatment option for patients with glaucoma. It is encouraging to see that the positive six-month results have been sustained at one year,” explained Professor Julián García-Feijoó from Hospital Clinico San Carlos, Complutense University, Madrid (Spain) and a STAR-II study investigator, who presented the data at AAO.
The STAR-II trial enrolled 29 patients with open-angle glaucoma in eight centres in France, Germany and Spain. Patients will be followed for two years post-intervention.
Promising longer-term data
The one-year STAR-II data are consistent with the one-year outcomes from the first MINIject trial, STAR-I. The final results from STAR-I, which enrolled 25 patients followed-up for two years, have just been published in the peer-reviewed British Journal of Ophthalmology (BJO). Two year results of the STAR-I trial show sustained IOP reduction and no issues with corneal health.
“With STAR-I and STAR-II trial results consistent at one year, we may expect them to be similarly comparable at two years. As an innovative standalone MIGS device, MINIject certainly has potential; we look forward to having a treatment option in the supraciliary space once more,” stated Dr Ike Ahmed, senior author of the BJO article and a STAR-I trial investigator, from University of Toronto, Canada.
Bio-integration and anti-fibrotic properties
The sustained performance shown by MINIject in patients may be connected to the bio-integration and anti-fibrotic properties of its STAR® material, according to pre-clinical trial results just published in the peer-reviewed journal BMC Biomedical Engineering.
Studies conducted in rabbits showed that MINIject bio-integrates with surrounding tissue. The STAR material’s porous structure gets colonised by neighbouring “healthy” cells that do not block the flow of aqueous humor through the device. Following this colonisation, no fibrosis, nor implant encapsulation, nor dense connective tissue obstructing drainage channels were observed, even though this animal model is known for its aggressive inflammatory response. Therefore, MINIject’s bio-integration and anti-fibrotic properties may help preserve its permeability and enhance long-term outflow, resulting in enduring IOP reduction.
“The consistently positive results from MINIject trials are gaining strong attention from the scientific and medical communities for its potential to improve outcomes for patients with glaucoma,” explained iSTAR Medical CEO, Michel Vanbrabant. “Our technology enables a new, truly bio-compatible approach for powerful, safe and enduring treatment, which we are eager to offer to patients soon,” he concluded.
Full press release from iStar Medical