MicroOptx has completed enrollment in the initial phase of its FDA investigational device exemption clinical trial of the Beacon aqueous microshunt, according to a press release.
The interventional, single-arm, open-label, multicenter Beacon trial aims to evaluate the device in terms of safety, performance and IOP reduction, which is the primary effectiveness outcome. The results will be used to expand the trial across 90 eyes.
The device works to lower and control IOP by shunting aqueous humor to the tear film. The U.S. pivotal clinical trial involves patients with refractory glaucoma