WAVRE, Belgium — 15 July 2021: iSTAR Medical, a med-tech company developing minimally-invasive implants for glaucoma surgery (MIGS), announced today that the U.S. Food and Drug Administration (FDA) granted it Investigational Device Exemption (IDE) to start a pivotal trial with MINIjectTM. The STAR-V study will investigate MINIjectTM in over 350 patients with primary open angle glaucoma. World-leading glaucoma surgeons in the US, Canada and Europe will join the trial.
The STAR-V trial evaluates MINIject’s efficacy by the mean reduction in eye pressure, as well as the proportion of patients achieving at least a 20 percent reduction in eye pressure. This study will report on safety and efficacy of MINIject alone, in a procedure not combined with simultaneous cataract surgery. Key study findings will become available when all patients have completed 2 years in the study.
Patients will also be followed to evaluate long-term benefits and tolerability of MINIjectTM in the treatment of mild to moderate glaucoma. Dr. Brian E. Flowers, a glaucoma specialist at Ophthalmology Associates of Fort Worth, TX, USA said
Michel Vanbrabant, CEO of iSTAR Medical, commented
iSTAR Medical SA is a private med-tech 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 second leading cause of adult blindness, affecting over 100 million people globally. 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.[1,2] Invasive surgery can present risks with irreversible complications.[1,2] 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.
 European Glaucoma Society Terminology and Guidelines for Glaucoma, 4th Edition: British Journal of Ophthalmology. 2017;101:1-195 https://bjo.bmj.com/content/101/5/73
 Glaucoma Surgical Device Market Report, published by Market Scope, 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