The US Food and Drug Administration (FDA) has approved an investigational device exemption (IDE) submission for Avisi Technologies’ glaucoma treatment device VisiPlate, a novel aqueous shunt, the company announced. The now-approved SAPPHIRE trial is a prospective, multicenter, open-label clinical trial with 1-year follow up, evaluating safety and effectiveness of VisiPlate aqueous shunt in patients with primary open-angle glaucoma. 

The VisiPlate is made of a patented metamaterial that has been designed to be nonfibrotic and is many times thinner than a human hair, according to the company, delivering ease of implantation and comfort. Its multiple, redundant microchannels are engineered to provide sustained aqueous flow while minimizing the risk of what Avisi said are 2 common challenges with currently available glaucoma surgical solutions—blockage and reintervention. 

VisiPlate has previously been studied in the VITA trial, with 6-month results reported at the 2025 American Glaucoma Society Annual Meeting. Jonathan Myers, MD, chief of the glaucoma service at Wills Eye Hospital in Philadelphia, will present 1-year data from the VITA trial at the upcoming American Academy of Ophthalmology annual meeting in Orlando on Sunday, October 19, 2025.