FDA Approves U.S. Trial of Avisi’s VisiPlate Glaucoma Device

Avisi Technologies has received Investigational Device Exemption (IDE) approval from the U.S. Food and Drug Administration (FDA) for its glaucoma treatment device, VisiPlate. This regulatory milestone allows the company to launch the SAPPHIRE clinical trial, which will evaluate VisiPlate’s safety and efficacy in patients with open-angle glaucoma in the United States.

VisiPlate: Investigating a Multichannel Approach to Glaucoma Treatment

VisiPlate represents a new class of surgical implants for glaucoma treatment. With a thin, biocompatible profile and a multichannel design, the device aims to offer sustained intraocular pressure (IOP) reduction while minimizing common complications such as scarring and implant failure.

“The VisiPlate device is a truly novel approach to treating open-angle glaucoma,” said Eydie Miller-Ellis, MD, Vice President of the American Glaucoma Society, Chief of Glaucoma Service at Scheie Eye Institute, University of Pennsylvania, and Principal Investigator for the SAPPHIRE trial.
“With its unique materials, thin profile, and multichannel approach, VisiPlate has the potential to bring sustained IOP control and safety to patients. I am excited by the promising long-term clinical trial data on VisiPlate collected thus far in countries outside of the U.S., and I’m thrilled to kick off SAPPHIRE in the U.S. with my colleagues.”

Clinical Data Building Momentum

VisiPlate has already undergone evaluation in the VITA Trial, with 6-month results previously presented by Dr. Miller-Ellis at the 2025 American Glaucoma Society Annual Meeting. These early findings demonstrated encouraging safety and IOP-lowering outcomes.

Looking ahead, 1-year data from the VITA Trial will be presented by Jonathan Myers, MD, Chief of Glaucoma Service at Wills Eye Hospital, Thomas Jefferson University, during the American Academy of Ophthalmology (AAO) Annual Meeting in Orlando.

“This FDA milestone marks the first time Avisi’s advanced treatment technology will be available to glaucoma patients in the U.S.,” said Dr. Myers.
“Current surgical treatments tend to fail due to blockage by scar tissue formation over time, but VisiPlate’s materials and multi-channel design potentially lower this failure risk. I am excited by this technology’s potential to yield improved outcomes and look forward to supporting the investigators in the SAPPHIRE trial.”