Two-Year Safety And Efficacy Results Of A Supraciliary Drainage Device In Patients With Open Angle Glaucoma – A Meta-Analysis From Star-I, Star-Ii And Star-Iii Trials

Describe the safety and efficacy profile 2 years after implantation of a novel, supraciliary, minimally-invasive glaucoma surgery drainage device, MINIject® (iSTAR Medical, Belgium) in patients with medically-uncontrolled, primary open-angle glaucoma.

The STAR-I, STAR-II and STAR-III trials are 3 prospective, multi-centre, interventional, single-arm, completed studies evaluating the safety and efficacy of MINIject in open-angle glaucoma patients. Across these trials, patients were treated at 11 sites in Germany, France, Spain, Colombia, India and Panama. The MINIject implant is a 5mm long network of hollow spheres made of soft, flexible silicone. It was implanted standalone and ab-interno into the supraciliary space.

Data up to 2-years after implantation from STAR-I (NCT03193736), STAR-II (NCT03624361) and STAR-III (NCT03996200) were pooled in a meta-analysis. In each study, patients were seen at a preoperative baseline visit and were assessed at regular intervals until 2 years after device implantation. The efficacy of the device in terms of reducing intraocular pressure and hypotensive medication use was assessed, as well as the safety profile at each timepoint. Results from a total of 66 patients who received the implant across these studies and who completed 2-year follow-up are presented here.

At 2-year follow-up, mean diurnal IOP was 14.4±4.5 mmHg, representing a 39% reduction from preoperative baseline (23.8±3.3mmHg, n=79). The mean IOP level and reduction were similar at all semi-annual follow-up visits until 2 years, representing a stable result over time. Similarly, medications were reduced from preoperative mean of 2.4±1.0 (n=79) to 1.3±1.4 at 2-year follow-up (39% reduction), with 41% of patients medication-free. IOP ≤18 mmHg was achieved in 85% of patients. The most common adverse events were: transient anterior chamber inflammation, IOP elevation, reduced visual acuity and visual field defect. The mean reduction in central endothelial cell density was 6%, with no patient exceeding 30% loss from preoperative baseline.

This meta-analysis strengthens the evidence for this supraciliary drainage device implanted in a standalone ab-interno procedure without requiring bleb management or needling. The implant achieved a powerful and stable efficacy (39% mean reduction in IOP at 2 years) and a reduction of hypotensive medications over 2-year follow-up. Moreover, patient safety was favourable. This supraciliary MIGS procedure may offer a valuable bleb-free treatment option for patients with glaucoma requiring low target pressures.