Avisi Technologies announced promising 6-month interim findings from a pilot study evaluating the use of its VisiPlate aqueous shunt among patients diagnosed with open-angle glaucoma (OAG).
The results were recently presented during the 2025 American Glaucoma Society’s annual meeting in Washington, DC.
First, tell me about Avisi.
Founded in 2017 and headquartered in Redwood City, California, the clinical-stage ophthalmic device company is developing a portfolio of novel metamaterial technology-based ophthalmic treatments.
Its disease target: glaucoma.
Now to this VisiPlate.
As Avisi's flagship minimally-invasive bleb surgery (MIBS) device, the VisiPlate is designed to lower intraocular pressure (IOP) via a microchannel network that controls aqueous drainage from the anterior surface and minimizes the risk for blockage.
How it works: The shunt is implanted in the subconjunctival space via an ab externo procedure with mitomycin C.
- Then: It “[wicks] pent-up aqueous humor from the inside of the eye to a secondary drainage zone” via this interconnect microchannel network (in lieu of a larger tube).
For a look at this in action, see below.
Talk more about its design.
The device is ultra-thin—Avisi describes it as “several times thinner than a human hair”—for greater patient comfort and aesthetics, and is composed of non-fibrotic nanotechnology-enabled metamaterials.
Those metamaterials (seen below) are intended to minimize foreign body response and reduce the risk for scarring:
- Alumina (aluminum oxide): A ceramic material with high hardness, thermal stability, and electrical insulation
- Parylene-C: A polymer used as a biocompatible, corrosion-resistant coating and optically transparent material (commonly utilized in other medical implants)
And its target is glaucoma?
Moderate-severe primary open-angle glaucoma (POAG), according to Avisi’s pipeline.
- Its intended users: Glaucoma surgeons
To note: A second version of the device (VisiPlate-S), currently in the pre-clinical stage, is under clinical investigation for use by cataract surgeons for mild-to-moderate glaucoma.
So what makes this device and procedure unique?
Eydie Miller-Ellis, MD, vice president of the AGS and director of Glaucoma at the University of Pennsylvania, Scheie Eye Institute, referred to the VisiPlate as “building a better bleb.”
Her reasoning: After trabeculectomy—or other filtering surgeries—blebs are often elevated and can cause patients discomfort.
- "That tendency of bleb shape is partially attributable to the single lumen outflow of other available stents,” she stated. “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.”
- The intent: To enable a more diffuse outflow of aqueous that is more comfortable for the patient.
To note: Dr. Miller presented the pilot study’s data during the AGS meeting.
Now let’s discuss that trial.
The multisite, prospective VITA trial evaluated the VisiPlate for its safety and effectiveness in treating 15 OAG patients (mean age: 55.6±17.1 years; races: 10 White, four Black/African descent, and one unspecified) with no prior filtration.
- The setup: Participants were implanted in one eye at three locations in South Africa.
- The duration: 12 months
- Baseline IOP: Average of 24.1 mmHg (18.8 mmHg to 40.2 mmHg)
To note: Avisi reported the study eyes required an average of two glaucoma medications (ranging from zero to four) over a 6-month period.
And what were these 6-month findings?
We’ll start with mean IOP.
- Investigators observed a 40.4% decrease to 14.0 mmHg—with a corresponding reduction to 0.8±1.1 medications.
In fact: Over three-fourths (78.6%) of study eyes achieved a ≥20% IOP reduction on the same (or fewer) meds—which, notably, surpassed the study’s primary effectiveness endpoints.
How many patients didn’t need any IOP-lowering medications?
By the 6-month mark: Over half of the 15 participants (57.1%, to be exact).
And the device’s overall performance?
Avisi reported that the VisiPlate demonstrated a “favorable safety profile” with no participant losing ≥2 lines of best-corrected visual acuity (BCVA), as well as no need for device removal or additional glaucoma procedures.
Even further: There were no reports of serious adverse events (AEs), with the most reported AEs being self-resolving pain and one (self-resolving) case of hypotony.
- “Specifically, there were no choroidal effusions that required drainage, there was no loss of light perception, there was no significant edema, and there was no persistent hypotony,” shared Dr. Miller.
Sounds promising! So what’s next?
Next up: 12-month data is expected to be announced from the pilot study (which has officially concluded) in the coming months.
And beyond that: With this latest study conducted in South Africa, the company is said to be planning a U.S.-based, FDA-approved trial in the near future.
Stay tuned for updates!