MicroOptx completes trial enrollment for Beacon aqueous microshunt
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 receiving the device as part of a stand-alone procedure.
“The Beacon device represents the next generation in microinvasive glaucoma surgery devices, or MIGS, striving for trabeculectomy effectiveness without the complications and required maintenance,” Chris Pulling, CEO, MicroOptx, said in the release.
In Europe, the company is conducting the Early BiRD trial, with about 25% of patients having more than 1 year of follow-up. In addition, MicroOptx completed enrollment in a U.S. feasibility study.
MicroOptx is pursuing initial regulatory approvals to begin marketing the treatment in the United States, Canada and the European Union.