VEO Ophthalmics, LLC, and Plexitome Medical have launched a new strategic partnership to introduce Plexitome’s namesake device for anterior stromal puncture (ASP) to treat recurrent corneal erosions (RCEs).
Let’s start with these players.
Headquartered in West Chester, Ohio, VEO develops and distributes ophthalmic surgical technologies (medical devices) for lens disorders.
Its first device—the CUSTOMFLEX ARTIFICIALIRIS—received FDA approval just 5 months after the company was founded in 2018, and launched for commercial use that October.
- That device is indicated for use as an iris prosthesis to treat iris defects in both pediatric and adult patients.
And Plextiome?
Plexitome Medical, on the other hand, is a medical device company specializing in surgical instruments for corneal care.
- Specifically: For the treatment of RCE and epithelial basement membrane dystrophies (EBMD).
- Notably: This is where its device comes in (more on that in a moment).
Let’s back up a moment and discuss RCE treatments.
While RCEs are typically treated and managed via conventional methods such as eye patching, lubricants, therapeutic bandage contact lenses, or autologous serum.
However: For those patients who do not respond to these treatments, ASP is an alternative option.
What this entails: Also referred to as epithelial enforcement, ASP is a minor in-office surgical procedure for RCEs (or other conditions causing an ongoing breakdown of the corneal surface) involving:
- The creation of superficial punctures through the corneal epithelium into the stroma using a small needle
- Stimulation of extracellular matrix protein production to securely reattach the corneal epithelium to underlying tissue
However, as Plexitome Founder and Chief Medical Officer Edward Chaum, PhD, MD, noted, such methods come with "unpredictability" and manual limitations—both of which are addressed in the Plexitome device.
Tell me about this device.
Plexitome is a single-use, FDA-registered Class 1 ophthalmic surgical device.
Its purpose: To reduce RCE patients’ long-term recurrence rates as well as enable stable epithelial attachments in EBMD to form.
And how does it do this?
First: The device features a 6.2 mm diameter disc array composed of ~ 675 individual spikes (described as similar to a circular bed of tiny nails).
When in use, up to 3,375 points of epithelial attachment are created over the entire treated corneal surface (with 5 imprints in total).
- Specifically, Plexitome provides a controlled and uniform puncture depth to ensure “penetration only through Bowman’s layer of the cornea.”
Noted. Now what makes this unique from other ASP methods?
Among its advantages, the device:
- Can be used to perform the procedure:
- With or without a slit lamp
- Through “loose intact epithelium to enhance epithelial layer attachment to Bowman’s membrane”
- Leaves behind no “optically evident anterior stromal scarring” following treatment
- May also improve the healing time of large corneal abrasions
- Appears (per its product brochure) to reduce the risk of corneal erosion recurrence
And as a bonus: It can also be used for treatment in the optical axis—a mechanism that is, most notably, not currently offered with current ASP methods.
- Check out the full brochure for visuals and details.
Any clinical data to back these claims up?
Indeed there is.
Results from an Institutional Review Board (IRB)-approved pilot study published in The Journal of Cornea and External Disease in 2024 supported the safety and efficacy of the Plexitome device for treating RCEs among 45 patients.
Those findings: Micropuncture of the cornea using the device left no “optically evident anterior stromal scarring” following treatment (with no significant adverse events associated either).
- As such: The study authors concluded that use of such a device “may be an effective way of treating RCE and other corneal manifestations of EBMD in the optical axis.”
Nice! And circling back to this new partnership … what’s the plan?
In a word: commercialization.
VEO is heading up the commercial rollout of the Plexitome device across the United States (and, eventually, the globe).
- With this, the company will also reportedly provide “access, training, and support to corneal specialists and surgical teams.”
And when can surgeons try the device for themselves?
Interested customers can reach out for a demo.
See here for a reimbursement guide, including details on CPT codes for ASP.