Avisi Technologies Presents Positive Six-Month Clinical Data for VisiPlate® Aqueous Shunt at the American Glaucoma Society

REDWOOD CITY, Calif., April 2, 2025 /PRNewswire/ -- Avisi Technologies, a clinical-stage ophthalmic device company, today announced encouraging six‐month interim results from the VITA trial evaluating its VisiPlate® device, an ultrathin, multichannel aqueous shunt in study subjects diagnosed with open-angle glaucoma. Data were presented by Eydie Miller-Ellis, MD, as a Top Paper at the American Glaucoma Society Annual Meeting in Washington, D.C.

Key Trial Data

The multi‐site VITA trial, a prospective pilot study designed to assess the safety and effectiveness of Avisi Technologies' investigational VisiPlate® device, enrolled and treated 15 subjects (mean age 55.6±17.1 years) with open-angle glaucoma and no prior filtration surgery. Subjects were implanted in one eye at three South African centers. Baseline intraocular pressure (IOP) of the cohort averaged 24.1 mmHg (ranging from 18.8 mmHg to 40.2 mmHg), with the study eyes requiring an average of 2.0 glaucoma medications (ranging from 0 to 4 medications). At six months following standalone VisiPlate® implantation:

• Mean IOP decreased by 40.4%, to 14.0 mmHg with a corresponding reduction to 0.8 medications.
• 78.6% of study eyes achieved a ≥20% IOP reduction on the same or fewer medications, exceeding the study's primary effectiveness endpoints.
• 57.1% of study eyes required no IOP-lowering medication.
• The VisiPlate® device demonstrated a favorable safety profile with no subject losing ≥2 lines of best-corrected visual acuity (BCVA), and no need for device removal or additional glaucoma procedures.

Device Features 

Avisi Technologies' VisiPlate® shunt is a unique design 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 healthy aqueous flow while minimizing the risk of blockage, a common challenge with currently available glaucoma surgical solutions.

Dr. Miller-Ellis, Vice President of the American Glaucoma Society and Director of Glaucoma at the University of Pennsylvania, Scheie Eye Institute, shared her excitement about the positive VisiPlate® performance in Ultrathin Shunt Shows Promising Results in Trial, an article by Jim Gallagher, Senior Managing Editor at Glaucoma Physician. "I call it 'building a better bleb,' because after trabeculectomy or other filtering surgeries blebs can be very elevated and cause the patient some discomfort," she noted. "That tendency of bleb shape is partially attributable to the single lumen outflow of other available stents. If all the aqueous is coming out in one outflow path, then the aqueous force is more concentrated centrally in the bleb, causing more elevation in that area. Our goal is to have a more diffuse outflow of aqueous that's more comfortable for the patient."

Dr. Miller-Ellis also noted that surgeons in the VITA trial found the VisiPlate® surgical procedure to be easier and faster than a standard trabeculectomy, with less involved postoperative management being required.

Expert Commentary

Joseph F. Panarelli, MD, Director of Glaucoma Services at NYU Langone Health and Professor of Ophthalmology at NYU Grossman School of Medicine, commented, "These results are very exciting and I'm anticipating having VisiPlate be a part of my practice in the future. I like the multichannel design and the potential for a straightforward surgery and simpler follow up. If we could have pediatric applications one day, that would be fantastic too."

Ehsan Sadri, MD, FACS, FAAO, Founder of Visionary Eye Institute, also shared his enthusiasm stating,

"The six-month VITA trial results for the VisiPlate® aqueous shunt are truly remarkable. A 40% reduction in IOP and over half of study eyes completely off medications—these are the kinds of outcomes we strive for in glaucoma care, especially when achieved through a minimally invasive approach. The metamaterial design and multichannel architecture of VisiPlate® represent a new frontier in safe, sustained IOP control.

As a surgeon committed to offering the most advanced and patient-centered care, I'm excited about the potential to incorporate VisiPlate® into my practice. Its ultrathin profile, ease of implantation, and impressive safety profile underscore the promise of this technology. I believe VisiPlate® could fundamentally shift how we manage moderate to advanced open-angle glaucoma and open the door to a better quality of life for our patients."

The paper presented by Dr. Miller-Ellis at the American Glaucoma Society Annual Meeting was the result of a strong international collaboration, with co-authors including Jonathan S. Myers, MD (Chief, Glaucoma Service at Wills Eye Hospital, Professor, Sidney Kimmel Medical College at Thomas Jefferson University), Lynette Venter, MD, MBChB, MMed (Ophth), FC Ophth(SA), Paul Roux, MD (Former Head of the Department of Ophthalmology at Pretoria University), Petrus Gous, MD (Founder of Pretoria Eye Institute), Laura Straub, Morné de Bruin, OD, and Eydie G. Miller-Ellis, MD.

Next Steps

The VITA trial is now complete. Full 12-month results will be announced at a future date.

About VisiPlate®

The investigational VisiPlate® aqueous shunt is Avisi Technologies' flagship "minimally invasive bleb surgery" (MIBS) device. Made from non-fibrotic nanotechnology-enabled metamaterials, it works by wicking pent-up aqueous humor from the inside of the eye to a secondary drainage zone via a network of interconnected microchannels, rather than a large tube. The device is engineered to lower IOP  while maintaining patient comfort and aesthetics. It is an investigational device and is not yet available for sale.

About Glaucoma

Glaucoma is the leading cause of irreversible blindness worldwide 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 primary open-angle glaucoma (POAG) and angle-closure glaucoma.

POAG, the most prevalent form of glaucoma, 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, POAG can cause gradual vision loss over time.

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, a sustained drug delivery platform, and a device to treat mild glaucoma. Avisi Technologies' VisiPlate device has been recognized as a promising new technology by numerous organizations, including the National Science Foundation, the Glaucoma Research Foundation, SXSW, Johnson & Johnson JLABs, Medtech Innovator Accelerator, UCSF Rosenman Institute, and the University of Pennsylvania, among others. Avisi has been funded by early-stage venture capital investors, angel investors, and research grants from the National Science Foundation. For more information, visit avisitech.com.

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SOURCE Avisi Technologies