Avisi Technologies releases positive 12-month data from VITA Trial

Avisi Technologies has released positive 12-month clinical data on the VisiPlate Aqueous Shunt from the VITA Trial. The VITA Trial is a prospective pilot study that was conducted at 3 centers by 3 separate implanting surgeons in South Africa.

The company describes the VisiPlate Aqueous Shunt as 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,” and that its “redundant microchannels are engineered to provide sustained aqueous flow while minimizing the risk of blockage and re-intervention.”¹

All patients in the trial (n=15) had previously been diagnosed with open-angle glaucoma (OAG) and had no prior history of filtration surgery.

According to the company, mean baseline diurnal IOP was 24.1 ± 6.2 mmHg, baseline glaucoma medications were 2.0 ± 1.5, and baseline visual field mean deviation was -11.7 ± 8.6 dB. Results showed that at 12 months, mean diurnal IOP was reduced to 13.1 ± 2.6 mmHg on 1.3 ± 1.5 medications, which is a change in diurnal IOP of –42.6% from baseline.

At the end of 12 months, nearly half (46.7%) of patients were not on glaucoma medication. Additionally, no adverse events were reported, and no patients had persistent vision loss.

Jonathan Myers, MD, chief of glaucoma service at Wills Eye Hospital, Thomas Jefferson University, presented these data during the 2025 American Academy of Ophthalmology (AAO) annual meeting and reviewed individual patient cases. In those cases, Myers reviewed slit lamp and Optical Coherence Tomography (OCT) images highlighting the placement of VisiPlate in the eye, not contacting anterior chamber structures like the iris and cornea. Myers stressed the resulting low-lying and diffuse blebs and the minimal postoperative burden.

According to Myers, “the tubeless nature of VisiPlate demonstrates promising effectiveness and safety in lowering IOP in OAG patients and has the potential to be a standardized filtration surgery with less postoperative management.”

VisiPlate is being studied in the US in the SAPPHIRE Trial (NCT07220876), a prospective, multicenter, single-arm, open-label clinical trial of the safety and effectiveness of the VisiPlate Aqueous Shunt. The current primary endpoint in the trial is the proportion of eyes achieving a ≥ 20% reduction in mean diurnal intraocular pressure over 12 months. The trial is hoping to enroll ~165 patients.²

What was the 6-month data of the VITA trial?

Earlier this year Avisi released 6-month data from the trial, showing that 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.³

Additionally, it was noted that the device demonstrated a favorable safety profile with no patient losing ≥2 lines of best-corrected visual acuity (BCVA), and no need for device removal or additional glaucoma procedures.³

Most recently, Avisi Technologies’ investigational device exemption (IDE) submission for VisiPlate was approved by the US Food and Drug Administration (FDA).⁴

References:

1. Avisi Technologies Announces Positive Twelve-Month Clinical Data of VisiPlate® Aqueous Shunt at AAO 2025. Published November 3, 2025. Accessed November 5, 2025. https://www.prnewswire.com/news-releases/avisi-technologies-announces-positive-twelve-month-clinical-data-of-visiplate-aqueous-shunt-at-aao-2025-302601291.html

2. Safety and Effectiveness of the VisiPlate Aqueous Shunt in Patients With Refractory Open-Angle Glaucoma. NCT07220876. Accessed November 5, 2025. https://clinicaltrials.gov/study/NCT07220876?tab=table

3. Harp MD. Avisi Technologies releases 6-month interim results from VITA trial. Published April 4, 2025. Accessed November 5, 2025. https://www.ophthalmologytimes.com/view/avisi-technologies-releases-6-month-interim-results-from-vita-trial

4. Harp MD. Avisi Technologies’ investigational device exemption for VisiPlate approved by FDA. Published October 15, 2025. Accessed November 5, 2025. https://www.ophthalmologytimes.com/view/avisi-technologies-investigational-device-exemption-for-visiplate-approved-by-fda