Avisi Technologies Reports Promising 6-Month Interim Results from VITA Trial on VisiPlate Device

Avisi Technologies has announced encouraging 6-month interim data from its ongoing VITA trial, showcasing the safety and efficacy of its VisiPlate device in treating open-angle glaucoma.

Data Presented at American Glaucoma Society Annual Meeting

The interim results were presented by Eydie Miller-Ellis, MD, Vice President of the American Glaucoma Society and Director of Glaucoma at the University of Pennsylvania, Scheie Eye Institute, during the American Glaucoma Society Annual Meeting held in Washington, D.C.

Overview of the VITA Trial Design

The VITA trial is a multi-site, prospective pilot study designed to evaluate the safety and effectiveness of the VisiPlate device, which is currently under investigation. The trial enrolled 15 patients (mean age 55.6±17.1 years) diagnosed with open-angle glaucoma and no prior filtration surgery.

Each participant received a single-eye VisiPlate implantation across three clinical sites in South Africa.

Baseline and 6-Month Clinical Outcomes

At baseline, the average intraocular pressure (IOP) among participants was 24.1 mmHg, with a range from 18.8 mmHg to 40.2 mmHg. Patients required an average of 2.0 glaucoma medications (ranging from 0 to 4).

At the 6-month mark:

       • Mean IOP dropped by 40.4% to 14.0 mmHg

       • Average medication usage decreased to 0.8

       • 78.6% of study eyes achieved a ≥20% IOP reduction on the same or fewer medications

       • More than 50% of study eyes required no IOP-lowering medications

These outcomes exceeded the study’s primary effectiveness endpoints, underscoring the potential of VisiPlate as a viable treatment option.

Favorable Safety Profile and Patient Comfort

Dr. Miller-Ellis highlighted the favorable safety profile of the device, noting:

       • No subject experienced a ≥2-line loss in best-corrected visual acuity (BCVA)

       • No device removals were necessary

       • No additional glaucoma procedures were required

Miller-Ellis emphasized the benefits of VisiPlate in creating a more physiologic bleb:

"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," Miller-Ellis stated.

Miller-Ellis explained that traditional stents typically feature a single lumen outflow, leading to centralized aqueous force and elevated blebs. In contrast, VisiPlate aims for diffuse aqueous outflow, which contributes to greater patient comfort.

Innovative Design and Surgical Advantages

The VisiPlate shunt is constructed from a patented metamaterial that is designed to be non-fibrotic and is several times thinner than a human hair. According to Miller-Ellis, surgeons participating in the trial found the surgical procedure to be easier and faster than a standard trabeculectomy, with less intensive postoperative management.