Avisi Technologies releases 6-month interim results from VITA trial

(Image Credit: AdobeStock/Melvin)

Avisi Technologies released 6-month interim results from the VITA trial evaluating its VisiPlate device. The data was 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, at the American Glaucoma Society Annual Meeting in Washington, D.C.

The multi‐site VITA trial is a prospective pilot study designed to assess the safety and effectiveness of Avisi Technologies' investigational VisiPlate device. It enrolled a total of 15 patients (mean age 55.6±17.1 years) with open-angle glaucoma and no prior filtration surgery. The VisiPlate device was implanted into one eye across 3 sites in South Africa.

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 6 months, mean IOP decreased by 40.4%, to 14.0 mmHg, with a corresponding reduction to 0.8 medications. Furthermore, 78.6% of study eyes achieved a ≥20% IOP reduction on the same or fewer medications, exceeding the study's primary effectiveness endpoints. Over half of study eyes required no IOP-lowering medicine.

Miller-Ellis also noted that the 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.

"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. "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."

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. Miller-Ellis 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.

References:

1. Avisi Technologies presents positive six-month clinical data for VisiPlate Aqueous Shunt at the American Glaucoma Society. Published April 2, 2025. Accessed April 3, 2025. https://www.prnewswire.com/news-releases/avisi-technologies-presents-positive-six-month-clinical-data-for-visiplate-aqueous-shunt-at-the-american-glaucoma-society-302418787.html