Q&A: Pantheon Vision developing alternative to donor tissue for corneal transplants

Key takeaways:

• Pantheon Vision is addressing the challenge of using donor tissue for corneal transplants.
• It is developing a 21st century keratoprosthesis based upon a novel elastomer material.

Despite a worldwide need for more corneal transplant tissue, few options exist beyond human donors.

According to a study published in JAMA Ophthalmology, just one cornea was available for every 70 needed in 2012.

John W. Sheets, PhD, president and CEO of Pantheon Vision, spoke with Healio about the company’s plans to develop an alternative to donor tissue for corneal transplants.

Healio: What is the current state of corneal transplants worldwide, and how is it impacting patients?

Sheets: The gold standard for many years has been corneal transplants using tissue from donors. The challenge is that the tissue is viable for only about 2 weeks after it is harvested from the donor eye, and when it is harvested, there is not much done to match it to the recipient eye. As a result, it has been a successful therapy but not as successful as one would expect for the 21st century. Ten percent of transplants fail in the first year, and 52% fail in 5 years.

Healio: What is Pantheon working on to change that paradigm?

Sheets: As we look at this opportunity, we are trying to come up with a shelf-stable product that would be available on a global basis and has better durability and visual outcomes than what corneal transplants have today. We are going to use a synthetic polymer that comes from a family of materials that has demonstrated long-term biocompatibility in multiple applications in the body. It is a clear and flexible material that will perform exceptionally well as an ophthalmic implant. Because we know the science behind all the materials that go into IOLs and contact lenses, we can then build our product around that technology base to provide a product that is going to have better outcomes than what you get with tissue implants.

The first application of our material was as a coating on the Taxus stent (Boston Scientific). A metal stent is coated with a flexible elastomer, which gives the ability to impregnate an anti-thrombogenic drug into the implant. Once it is deployed in the body, it emits the drug and prevents the formation of any further thrombus that clogs the arteries. This same elastomer was later used on a glaucoma shunt, and it is performing well in the eye in that application.

We are taking an offshoot of that family of materials and making it into our corneal inlay. We expect to have better durability than what has been the experience with corneal implants and transplants of the past. We want to have a primary implant that will perform exceptionally well and will be easy to implant and that surgeons will look forward to using.

Healio: Where are you in development, and what are the future goals for the technology?

Sheets: We are in preclinical studies, and we currently have intensive rabbit studies to demonstrate its safety. Once we have completed those, we are going to move into clinical studies to get approval on a global basis. Ideal Medical, a Chinese manufacturing company with a CE mark and a well-engineered manufacturing process, is making the prototypes for us.

We have had three meetings with the FDA, including two pre-submission meetings in early 2024 and an informational meeting in November 2024. The agency is excited about what this product can yield.

As a startup, we have some great investors with CareLink International, but we are going to need additional investment to take the product through clinical studies and into the market.

We want to provide better innovation for patients in America, and we want to give the talented clinicians who take care of these patients more and better tools to be able to provide better care.

Reference:

For more information:

John W. Sheets, PhD, can be reached at jsheets@pantheonvision.com.

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