Avisi Technologies’ investigational device exemption for VisiPlate approved by FDA

Avisi Technologies’ investigational device exemption (IDE) submission for its glaucoma treatment device VisiPlate has been approved by the US Food and Drug Administration (FDA).¹

As defined by the FDA, an IDE allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data. Additionally, an approved IDE permits a device to be “shipped lawfully for the purpose of conducting investigations of the device without complying with other requirements of the Food, Drug, and Cosmetic Act (FD&C Act) that would apply to devices in commercial distribution.”²

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, commented on the device in a press release from the company.

“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 Miller-Ellis.

The VisiPlate aqueous shunt is made of a patented metamaterial that has been designed to be non-fibrotic and is many times thinner than a human hair, according to the company. Additionally, its “multiple, redundant microchannels are engineered to provide sustained aqueous flow while minimizing the risk of blockage and re-intervention.”

According to the VITA trial 6-month results,³ mean IOP decreased by 40.4%, to 14.0 mmHg with a corresponding reduction to 0.8 medications. Additionally, 78.6% of study eyes achieved a ≥20% IOP reduction on the same or fewer medications, and 57.1% of study eyes required no IOP-lowering medication.

The trial enrolled and treated 15 subjects (mean age 55.6±17.1 years) with open-angle glaucoma and no prior filtration surgery. Patients in the trial were implanted in 1 eye at 3 South African centers.

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.

“This FDA milestone marks the first time Avisi’s advanced treatment technology will be available to glaucoma patients in the US,” said 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.”

References:

1. Avisi Receives FDA Approval to Study Novel Approach to Glaucoma Treatment. Published October 14, 2025. Accessed October 15, 2025. https://avisitech.com/avisi-receives-fda-approval-to-study-novel-approach-to-glaucoma-treatment/

2. The United States Food and Drug Administration. Investigational Device Exemption (IDE). Accessed October 15, 2025. https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/investigational-device-exemption-ide

3. Avisi Technologies Presents Positive Six-Month Clinical Data for VisiPlate Aqueous Shunt at the American Glaucoma Society. Published April 2, 2025. Accessed October 15, 2025. https://avisitech.com/avisi-technologies-presents-positive-six-month-clinical-data-for-visiplate-aqueous-shunt-at-the-american-glaucoma-society/