Avisi Technologies Receives FDA Approval to Study Novel Approach to Glaucoma Treatment

• 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 glaucoma patients.
• VisiPlate® shunt is uniquely designed: novel metamaterial, thinner than a human hair, aiming for longevity, comfort, and aesthetics.
• The multiple, redundant microchannels provide sustained aqueous flow while minimizing the risk of blockage and re-intervention.

REDWOOD CITY, Calif., Oct. 14, 2025 /PRNewswire/ -- Avisi Technologies, Inc., an ophthalmic medical device company advancing novel, sight-saving technologies, announces that the US Food and Drug Administration (FDA) has approved an investigational device exemption (IDE) submission for Avisi's glaucoma treatment device VisiPlate^®.

"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 Dr. Eydie Miller-Ellis, 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 studied in the VITA Trial, with 6-Month results reported by Dr. Miller-Ellis at the 2025 American Glaucoma Society Annual Meeting. Dr. Jonathan Myers, 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 presentation will take place in the Orange County Convention Center at Avisi's Booth, #3467, on October 19, 2025 at 1pm 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."

Remarking on the global impact of glaucoma and VisiPlate's role in the landscape of current treatments, the Founder and CEO of Avisi, Rui Jing Jiang, said - "Glaucoma is a debilitating disease that is estimated to affect over one hundred million patients globally. Its incidence is expected to grow with our rapidly aging population. Current treatments face risks of noncompliance, blockage, and re-intervention, all of which are costly to patients, caregivers, and healthcare systems. VisiPlate has been designed to overcome these shortcomings. We are grateful to our collaborators and the FDA, as the data collected from SAPPHIRE will play a critical role in demonstrating the impact of this potentially revolutionary technology."

About VisiPlate®
Avisi Technologies' VisiPlate® aqueous shunt is a unique device made of a patented metamaterial that has been designed to be non-fibrotic and is many times thinner than a human hair. The device is both doctor and patient-centric, designed for ease of implantation, longevity, comfort, and aesthetics. Its multiple, redundant microchannels are engineered to provide sustained aqueous flow while minimizing the risk of blockage and re-intervention, both common challenges with currently available glaucoma surgical solutions.

About Glaucoma and Current Treatment:
Glaucoma  is the leading cause of irreversible blindness worldwide, affecting over 103 million people according to Market Scope's 2021 Glaucoma Surgical Device Market Report, and currently has no cure. In glaucoma patients, excess fluid builds up within the eye, increasing pressure on the optic nerve and leading to permanent vision loss. Glaucoma is a group of diseases, the most common of which are open-angle glaucoma (OAG) and angle-closure glaucoma.

OAG often has no early warning signs or symptoms. It occurs when the eye's drainage system (trabecular meshwork) becomes clogged, preventing normal fluid outflow and leading to elevated eye pressure. Without diagnosis and treatment, OAG can cause gradual vision loss over time. Current treatments for glaucoma include medications, lasers, surgeries, and medical device solutions. However, these interventions rely on patient compliance, re-treatment, or may fail due to occlusion and scarring over time. There remains a pressing need for safe and effective long-term treatments for glaucoma that improve patient outcomes and quality of life.

About Avisi Technologies
Avisi Technologies  is a clinical-stage medical device company committed to advancing vision care through innovative ophthalmic solutions. The company's portfolio includes state-of-the-art treatments for glaucoma and other ocular conditions. These include its flagship VisiPlate® aqueous shunt, V-001 sustained intraocular drug-delivery platform, and the VisiPlate-S drainage device for treating glaucoma at the time of cataract surgery. Avisi has been recognized and supported by numerous organizations, including the National Science Foundation (NSF), the Glaucoma Research Foundation, SXSW, Johnson & Johnson JLABs, Medtech Innovator Accelerator, UCSF Rosenman Institute, and the University of Pennsylvania, among others. Avisi is funded by venture capital investors, angel investors, and scientific research grants. For more information, visit avisitech.com.

More information on the SAPPHIRE clinical trial

SOURCE Avisi Technologies