iSTAR Medical, a medtech company pioneering novel minimally-invasive implants for glaucoma surgery (MIGS), has announced final results of the STAR-II European trial for its MIGS device, MINIjectTM. These data show consistently outstanding performance and a favourable safety profile in patients with primary open-angle glaucoma up to two years of follow-up. The trial results were recently presented at the 125th American Academy of Ophthalmology (AAO) meeting in New Orleans, LA
Two-year results from STAR-II
The two-year results from the MINIject STAR-II European trial indicated sustained, powerful efficacy and favourable safety outcomes in patients with primary open-angle glaucoma. Consistent with all MINIject trial outcomes to date, mean intraocular pressure (IOP) was remarkably reduced by 36% from 24.6mmHg at baseline to 15.5mmHg at two-year follow-up, with a 52% reduction in glaucoma medication use from 2.9 at baseline to 1.4 at trial completion. Furthermore, corneal health results in this study were outstanding, which is of pivotal importance for long-term safety.
In the STAR-II trial, 29 patients with open-angle glaucoma were implanted with MINIject across eight centres in Germany, France and Spain. These patients were followed for two years post-intervention.
Three-year data from STAR-GLOBAL
In addition, interim data from the STAR-GLOBAL trial indicate that MINIject’s sustained efficacy and safety results, including the limited need for reoperations, have now been maintained for up to three years, with favourable results for corneal health.
STAR-GLOBAL is a prospective, long-term follow-up trial, which enrolls patients already implanted with MINIject and followed for two years as part of previous STAR trials, to evaluate long-term efficacy and safety up to five years.
Unlike MIGS devices commercially available, MINIject is implanted into the supraciliary space, a natural fluid-drainage pathway for powerful reduction of eye pressure. Unlike previous supraciliary MIGS devices, MINIject has not seen issues with scarring around the implant (fibrosis) nor substantial reductions of corneal cell health.
MINIject leverages the advantages of the supraciliary space
Unlike MIGS devices commercially available, MINIject is implanted into the supraciliary space, a natural fluid-drainage pathway for powerful reduction of eye pressure. Unlike previous supraciliary MIGS devices, MINIject has not seen issues with scarring around the implant (fibrosis) nor substantial reductions of corneal cell health.
“The antifibrotic properties and flexible structure of the MINIject porous proprietary STAR material are enabling a safe use of the supraciliary space while unlocking unprecedented MIGS results in patients with glaucoma. These results indicate a balance of sustained efficacy and favourable safety, and may conclusively demonstrate in time that MINIject outperforms alternative MIGS options,” said iSTAR Medical CEO, Michel Vanbrabant.
Full press release: www.istarmed.com/2021/11/12/istar-medical-present-final-results-star-ii-european-trial-miniject-glaucoma-patients-aao/