■ iStar Medical said the FDA granted it an Investigational Device Exemption to start a pivotal trial with the Miniject. The STAR-V study will investigate Miniject in more than 350 patients with primary open-angle glaucoma.

The STAR-V trial will evaluate Miniject's efficacy by the mean reduction in eye pressure, as well as the proportion of patients achieving at least a 20% reduction in eye pressure. This study will report 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 Miniject in the treatment of mild to moderate glaucoma.