WAVRE, Belgium — 12 November 2021: iSTAR Medical, a medtech company pioneering novel minimally-invasive implants for glaucoma surgery (MIGS), today 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 will be presented at the 125th American Academy of Ophthalmology (AAO) meeting in New Orleans, LA (USA), from 12 to 15 November 2021.
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.
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.,,,,
The STAR-II and STAR-GLOBAL outcomes will be available as on-demand posters throughout the AAO meeting, starting from Friday 12 November.
About iSTAR Medical
iSTAR Medical SA is a medtech company developing minimally invasive ophthalmic implants for the treatment of glaucoma patients. iSTAR Medical has exclusive rights for ophthalmic use of the STAR® material, developed by the University of Washington, Seattle (USA). STAR has outstanding anti-fibrotic and anti-inflammatory properties and a unique porous structure that enhances natural fluid outflow. iSTAR Medical was founded in 2011 and is headquartered in Wavre, Belgium. www.istarmed.com
MINIject is iSTAR Medical’s revolutionary MIGS device for patients with primary open-angle glaucoma. MINIject combines the unique porous structure of its proprietary STAR material with the power offered by the supraciliary space. As a result, it is designed to enhance natural fluid outflow, reducing intraocular pressure (IOP) and the need for medication, while bio-integrating with surrounding tissue, limiting inflammation, fibrosis and subsequent complications.
Glaucoma is a progressive disease and the leading cause of irreversible blindness, affecting over 100 million people globally, of which primary open-angle glaucoma is the most common form.[6,7] IOP reduction, through medication or surgery, helps delay disease progression. Medication is generally the first line treatment, but the progressive addition of multiple drops can burden patients with side effects, compliance challenges and costs.[6,8] Invasive surgery can present risks with irreversible complications.[6,8] MIGS is the most promising and fastest-growing glaucoma therapy due to its enhanced safety profile. MINIject is potentially best-in-class for its promising long-term efficacy and safety.
 Lass, J.H., Benetz, B.A., He, J., et al. Corneal Endothelial Cell Loss and Morphometric Changes 5 Years after Phacoemulsification with or without CyPass Micro-Stent. Am J Ophthalmol, 2019; 208: 211–218, doi: 10.1016/j/ajo.2019.07.016.
 HORIZON data submitted to FDA: https://www.accessdata.fda.gov/cdrh_docs/pdf17/P170034B.pdf
 iStent inject data submitted to FDA: http://www.accessdata.fda.gov/cdrh_docs/pdf17/P170043B.pdf
 Grierson, I., Minckler, D., Rippy, M.K., et al. A novel suprachoroidal microinvasive glaucoma implant: in vivo biocompatibility and biointegration. BMC Biomed Eng, 2020; 2, 10, doi: 10.1186/s42490-020-00045-1.
 Denis, P., Hirneiß, C., Durr, G.M., et al. Two-year outcomes of the MINIject drainage system for uncontrolled glaucoma from the STAR-I first-in-human trial. Br J Ophthalmol. 2020; 0:1–6, doi: 10.1136/bjophthalmol-2020-316888
 Market Scope, “Glaucoma Surgical Device Market Report”, August 2020. https://www.market-scope.com/pages/reports/202/2020-glaucoma-surgical-device-market-report-a-global-analysis-for-2019-to-2025-august-2020
 Jonas JB, Aung T, Bourne RR et al. “Glaucoma”. Lancet 2017; 390: 2083–93
 European Glaucoma Society, “Terminology and Guidelines for Glaucoma”, 4th Edition: B J Ophthalmol. 2017; 101:1-195, doi: 10.1136/bjophthalmol-2016-EGSguideline.002