Pantheon Vision and Eyedeal Medical Technology Co., Ltd. are collaborating to advance and commercialize Pantheon’s investigational bioengineered corneal implant.
Refresh me on these companies.
Starting with Eyedeal Medical: The China-based medical device manufacturer produces ophthalmic products such as medical grade polymers and implantable medical devices.
- Included in this lineup: Intraocular lenses (IOLs), orthokeratology lenses, and glaucoma drainage tubes.
Moving on to Pantheon: The Baltimore, Maryland-based preclinical medical device company is working to reduce the global reliance on donated corneal tissues via the development of a bioengineered corneal implant—notably, the focus of this new partnership.
Before we get to the implant, what does this collaboration involve?
The companies’ agreement entails both Pantheon and Eyedeal Medical to work on advancing the production and commercialization of the corneal implant.
According to Eyedeal Medical CEO Guo Guangxo, the plan is to expedite clinical implementation of the implant to restore vision for corneal disease patients worldwide at the earliest possible date.
No further details were disclosed.
Got it. Let’s talk about this corneal implant.
What we know: The implant is described as a “single-piece polymer artificial cornea” intended to address issues, complications, and lifestyle barriers (economical, cultural, technological, etc.) associated with the success rate of human-donated tissue for corneal transplantation.
- As such, its purpose involves reducing—and eventually eliminating—the reliance on human donor cornea availability and tissue banks.
But isn’t the success rate of corneal transplants already high?
At 97%, it definitely is. However, despite its high marks for restoring vision, it’s the global demand for such transplants—and, as a result, donated human corneas—that has become an issue.
Essentially: The demand for corneal transplants across the globe is far outweighing the availability of donated corneas.
And that’s where this bioengineered implant comes into play, right?
Exactly. Such an implant would greatly alleviate the estimated 12.7 million donated human corneas currently in demand.
And while we don’t know the specific details of Pantheon’s implant in development, previous clinical research published in Nature Bioscience exploring the use of bioengineered cell-free implantable medical devices as substitutes for human corneal stromal tissue among keratoconus patients yielded positive outcomes.
- The crux of those findings: Following 24 months of follow-up, the devices’ potential in restoring vision was deemed to be “equally effective, safer, simpler and more broadly available than donor cornea transplantation.”
For other supporting research: See here, here, and here.
Definitely sounds promising. So what’s the latest on Pantheon’s implant?
Since the company’s launch in 2023, it has successfully raised over $4 million in seed funding (see here and here) to support the implant’s development and advancement.
A key financier of these funds is the 501(c)3 nonprofit KeraLink International, which is owned by the largest global provider of corneal tissue for transplantation: CorneaGen.
And on the regulatory side?
Early last month, Pantheon reported it had completed its third pre-submission meeting with the FDA’s review team regarding the corneal implants—focused specifically on their design and bioengineered materials.
The purpose of these meetings: For the FDA to offer guidance on the initial stage of pre-clinical and clinical work that Pantheon needs to support a future premarket approval (PMA) submission of the bioengineered corneal implants.
- See here for a look at the step-by-step PMA process.
Something to keep in mind: The company previously shared it expects to meet with the FDA again in the spring as it progresses in the implants’ clinical development.