The FDA has granted EyeYon Medical, Ltd., investigational device exemption (IDE) approval for the initiation of a U.S. clinical study to evaluate EndoArt, the company’s synthetic endothelial layer for the treatment of chronic corneal edema (CCE).
Let’s start with EyeYon.
Operating out of Israel, the ophthalmic medical device company is dedicated to developing solutions for corneal diseases—specifically to improve outcomes, reduce reliance on donor tissue, and enable more global accessibility of vision care.
Among these solutions:
- EndoArt → its flagship product (more on this in a moment)
- Hyper-CL therapeutic contact lenses
- Referred to as the market’s “first ocular drug depot system in the form of a non-invasive, comfortable, and easy-to-use contact lens” for enhancing drug absorption and more effective corneal pathology treatment.
Before we get to EndoArt … refresh me on this IDE.
An IDE is a regulatory submission to the FDA that allows an investigational device (such as the Calibreye system) to be evaluated for safety and effectiveness in a clinical trial.
See here for a more detailed rundown on its purpose.
Now to EndoArt.
What it is: A corneal artificial endothelial layer touted as the "first ever synthetic implant to treat corneal edema and improve vision”—with a 3-year shelf life.
Looking at its composition, EndoArt is made of a sterile biocompatible material (acrylic hydrophilic) that’s “inherent to the human tissue.”
And how does it work?
By attaching to the back of the corneal surface to prevent fluids from transferring into the cornea and inhibiting fluid buildup (edema).
- This minimally-invasive procedure is performed—using a technique similar to Descemet membrane endothelial keratoplasty (DMEK)— via small incisions to prevent further injury to “fragile eye tissue” as well as enable a “high degree of implantation success,” according to EyeYon.
As for the procedure’s duration: It takes just 30 to 40 minutes—and is performed under sedation.
- See here for a look at the three-step process (including a training video).
What advantages come with this?
A few key benefits, such as its:
- Instant availability, with a 3-year shelf life
- Complete elimination of the need for human donor tissue
- Requires less medications (versus traditional corneal treatment)—with reportedly “no risk for disease transfer”
And which patients are the best candidates for the implant?
EyeYon identified seven clinical profiles of patients who’d most benefit from the EndoArt’s management of epithelial disorders:
- The regraft patient (post-graft failure patients)
- The tubed eye patient (glaucoma patients with prior drainage implants)
- The silicone oil eye patient (vitrectomised eyes or silicone oil-filled eyes)
- The tissue shortage patient (patients facing long wait times for human tissue)
- The non-donor candidate (patients with cultural or religious restrictions)
- The complicated eye patient (patients with a complex ocular history)
- The low-visual potential patient (patients with severe corneal edema outside standard indications)
What does its regulatory status look like?
In the United States, EndoArt is an investigational device that has received Breakthrough Device designation from the FDA.
Outside the U.S., however: The technology received a CE mark (the European Union’s equivalent of an FDA approval) to be used as an endothelial prosthesis for chronic corneal edema in 2021 before launching to the commercial market in September 2023.
- In September 2024, EyeYon reported its 400th commercial implant in September 2024 (and has since surpassed 800).
Next up: this U.S.-based study that’s in the works.
While the EndoArt has reportedly undergone clinical evaluations in various clinical studies outside of the United States, this new trial is a first within the country.
What we know so far:
- The study will be led by Francis Mah, MD, director of Cornea and External Disease at Scripps Clinic Medical Group and based in La Jolla, California.
- Its clinical investigation will be conducted by at least 10 leading surgeons at surgical centers across the country.
Do we know when it will kick off?
Unfortunately, details have not yet been released regarding the study’s design, setup, participants, or outcome measures—as well as the timing for initiation.
Not much to go off of … is there any prior research on the EndoArt we can view?
Indeed (quite a bit, in fact). See here for a look at the vast collection of clinical research.
Among the data: Long-term (6-year) follow-up findings published earlier this year in Cornea Journal on a retrospective case series of five patients (five eyes) who underwent the EndoArt implantation.
The gist of those findings: A significant reduction of corneal edema was observed, along with a favorable safety profile in select patients—and no serious adverse events.