Avisi Technologies Receives FDA Approval to Study Novel Approach to Glaucoma Treatment
Avisi Technologies announced that the FDA has approved an investigational device exemption (IDE) for its glaucoma treatment device, VisiPlate. This milestone paves the way for the company’s SAPPHIRE clinical trial, which will evaluate the device in patients with open-angle glaucoma in the United States.
“The VisiPlate device is a truly novel approach to treating open-angle glaucoma. With its unique and biocompatible materials, thin profile, and innovative multichannel approach, VisiPlate has the potential to bring sustained IOP control and safety to patients,” said Eydie Miller-Ellis, MD, Vice President of the American Glaucoma Society, Chief of Glaucoma Service at Scheie Eye Institute, University of Pennsylvania, and a Principal Investigator in SAPPHIRE. “I am excited by the promising long-term clinical trial data on VisiPlate collected thus far in countries outside of the US, and I am thrilled to kick off SAPPHIRE in the US with my colleagues.”
VisiPlate has previously been evaluated in the VITA Trial, where 6-month results were reported by Dr. Miller-Ellis at the 2025 American Glaucoma Society Annual Meeting. Building on these findings, Jonathan Myers, MD, Chief of Glaucoma Service at Wills Eye Hospital, Thomas Jefferson University, will present 1-year data from the VITA Trial at the American Academy of Ophthalmology (AAO) Annual Meeting in Orlando. The presentation will take place at Avisi’s Booth #3467 in the Orange County Convention Center on October 19, 2025, at 1:00 PM ET.
“This FDA milestone marks the first time Avisi’s advanced treatment technology will be available to glaucoma patients in the US,” 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.”