The FDA has granted approval to Avisi Technologies for its investigational device exemption (IDE) submission for the VisiPlate, a novel glaucoma treatment device.
First things first: Explain this IDE.
What it is: An FDA regulatory submission enabling an investigational device (Avisi’s VisiPlate, for instance) to be evaluated in a clinical trial for its safety and effectiveness.
To note: Unless otherwise exempted, all clinical evaluations of such a device must have an approved IDE in place prior to a study’s initiation—or (if not) face the consequences.
- These studies are also typically conducted to support a device’s premarket approval (PMA) submission for FDA clearance.
Alrighty, now to Avisi—what should we know about it?
The California-based clinical-stage ophthalmic device company’s operations revolve around developing a portfolio of novel metamaterial technology (nanotechnology)-based ophthalmic treatments for glaucoma.
And this device in particular?
The company’s flagship (investigational) product: the VisiPlate aqueous shunt.
What it is: A minimally-invasive bleb surgery (MIBS) device designed to lower intraocular pressure (IOP) in patients with open-angle glaucoma (OAG).
- How: Via a microchannel network that controls aqueous drainage from the anterior surface and minimizes the risk for blockage.
Talk more about its design.
The device is ultrathin (5 mm wide and 9 mm long) and made from an alumina (aluminum oxide) plate coated with parylene-C (a polymer used in medical implants for stronger structural integrity).
- To note: Those metamaterials are designed to minimize foreign body response and reduce the risk for scarring.
Its differentiation from other (single-tube stent) implants: VisiPlate has a flat profile with multiple channels.
Explain its process more.
- The shunt is first implanted in the subconjunctival space through an ab externo procedure performed with mitomycin C.
- It then uses its network of microchannels (instead of a single lumen or tube), which distribute aqueous humor flow across the implant surface and into the subconjunctival space.
- A portion (1 mm) of the implant is inserted into the anterior chamber, in which aqueous is then picked up at the tip
- From there, the aqueous passes through the microchannels across the body of the VisiPlate device and into the subconjunctival space to form—and this is key—a diffuse, low-lying bleb.
Why is that key?
Blebs are typically elevated (high-domed) and cause patient discomfort following trabeculectomy or other filtering surgeries.
- See here for why clinicians refer to the VisiPlate as “building a better bleb.”
Next up: the reason for this IDE.
That would be Avisi’s plans to conduct the (now approved) SAPPHIRE trial.
About this study: The prospective, multicenter, open-label, U.S.-based clinical trial will evaluate the safety and effectiveness of the VisiPlate in glaucoma patients, with a 1-year follow-up also planned.
Any other details on it?
Not so far. That goes for plans to enroll participants, the setup, and what will be measured..
And according to the company, a ClinicalTrials.gov number has yet to be assigned.
Darn. So … how has VisiPlate performed in clinical trials so far?
The results are promising. As we reported in April 2025, 6-month interim findings from an ongoing pilot study (dubbed VITA) found VisiPlate demonstrated a “favorable safety profile” when implanted among OAG patients.
- See here for details on the significant decreases observed for IOP (as well as the 57% of patients who didn’t require any IOP-lowering medications following implantation).
Promising indeed! And has any new data been reported on this trial since then?
Funny you should ask … 1-year findings are actually being presented this weekend during the 2025 American Academy of Ophthalmology (AAO) annual meeting in Orlando, Florida.
- When and where: Oct. 19 at 1 p.m. EST at the Avisi booth (#3467)
- The presenter: Jonathan Myers, MD, chief of Glaucoma Service at Wills Eye Hospital, Thomas Jefferson University
And if you’re not attending AAO, check back here next week for the rundown on those findings!