Avisi Technologies treats first patient in SAPPHIRE trial for glaucoma

Avisi Technologies has treated the first patient in the international SAPPHIRE trial (NCT07220876) with the company’s glaucoma treatment device VisiPlate.

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 It is intended for the treatment of patients with open-angle glaucoma (OAG).

The SAPPHIRE trial is currently underway across several sites across the US, with more site activations scheduled for 2026. According to the company, approximately 65 patients will be treated in the SAPPHIRE trial across 13 locations, and the resulting data is anticipated to support future FDA applications.

The primary endpoint of SAPPHIRE is the proportion of patients achieving a clinically significant reduction in diurnal IOP at 12 months when compared to baseline, on the same or fewer number of glaucoma medications. Additionally, important safety evaluations and patient feedback, including vision quality, will be obtained through 12 months.

Rui Jing Jiang, founder and CEO of Avisi, commented on the surgery, saying, "VisiPlate is an advanced technology designed to maximize patients' quality of life. Dr Snyder's successful VisiPlate surgery progresses a needed solution for managing glaucoma and preserving vision. We are grateful for the expertise of our physician collaborators and look forward to treating more glaucoma patients through the SAPPHIRE trial."

The investigational device exemption (IDE) submission for the VisiPlate was approved by the US Food and Drug Administration (FDA) in October 2025.² This allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data. Additionally, an approved IDE permits a device to be “shipped lawfully for the purpose of conducting investigations of the device without complying with other requirements of the Food, Drug, and Cosmetic Act (FD&C Act) that would apply to devices in commercial distribution.”

The VisiPlate was most recently studied in the 12-month VITA trial in South Africa. Data from the trial showed at the end of 12 months, nearly half (46.7%) of patients (n=15) were not on glaucoma medication. Additionally, no adverse events were reported, and no patients had persistent vision loss.³

Additional data from the VITA trial 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.

References:

1. Avisi Technologies Announces First Patient Implanted with VisiPlate® Glaucoma Treatment Device in the SAPPHIRE Trial. Published December 2, 2025. Accessed December 2, 2025. https://www.prnewswire.com/news-releases/avisi-technologies-announces-first-patient-implanted-with-visiplate-glaucoma-treatment-device-in-the-sapphire-trial-302630355.html

2. Harp MD. Avisi Technologies’ investigational device exemption for VisiPlate approved by FDA. Published October 15, 2025. Accessed December 2, 2025. https://www.ophthalmologytimes.com/view/avisi-technologies-investigational-device-exemption-for-visiplate-approved-by-fda

3. Harp MD. Avisi Technologies releases positive 12-month data from VITA Trial. Published November 5, 2025. Accessed December 2, 2025. https://www.ophthalmologytimes.com/view/avisi-technologies-releases-positive-12-month-data-from-vita-trial