John W. Sheets, PhD, discusses Pantheon Vision’s bioengineering solutions for corneal transplants
In this episode of The Ophthalmic Project, Mark Dlugoss, Senior Contributing Editor for Ophthalmology 360, interviews John W. Sheets, PhD, about Pantheon Vision’s bioengineering solutions for corneal transplants.
Mark Dlugoss:
More than 13 million people globally are affected by corneal blindness. Over the years, corneal transplant surgery has become the gold standard for addressing corneal diseases, yet significant improvements are still needed in graft acceptance, vision restoration, and longevity if ophthalmic surgeons are to overcome corneal blindness.
Hello, this is Mark Dlugoss, Senior Contributing Editor for Ophthalmology 360, and welcome to The Ophthalmic Project powered by Ophthalmology 360. In today’s Ophthalmic Project, we will learn about a new company that has emerged within the past year that hopes to develop alternative solutions for corneal transplants. Joining The Ophthalmic Project to provide some insight into these new alternatives is John W. Sheets, PhD, President and CEO of Pantheon Vision. John, welcome to The Ophthalmic Project.
John W. Sheets, PhD:
Thank you, Mark. Appreciate it. Glad to be here.
Mark Dlugoss:
Thank you for joining us. I really appreciate it. First of all, before we go any farther and we start talking about the company, let’s talk about you a little bit. Can you give me a little background of where you’ve been, what you do in ophthalmology, and what other lives you’ve had in the space?
John W. Sheets, PhD:
Certainly. I’m very fortunate that I’ve enjoyed the last 42 years working in the ophthalmic space. Got started when I was in graduate school at the University of Florida. I was studying biomaterials and Herb Kaufman, the then-chairman of the Department of Ophthalmology at Florida, approached us with what he thought was a toxic effect coming from the newly implanted interocular lenses. I partnered with a number of his residents, and we began to study what was really going on and found out, in fact, it was not a toxic effect, but it was an adherence of the interocular lens to the corneal endothelium that caused damage to the cornea. That led to corneal decompensation and eventual cloudy edematous corneas. We began working on different solutions to that product problem. That ended up becoming my dissertation, and eventually, we created some IP about that technology. Got licensed to the first company I went to work for back in the early 1980s out in Pasadena, California, called Intermedics Interocular. We were able to get the product into clinical study, but at the time, there was a big shift from putting anterior chamber IOLs in place and then putting them into posterior chamber, and it kind of eliminated the need for that kind of technology.
Eventually, of course, there was the predominance of use of hyaluronic acid viscoelastics to protect the cornea, but that’s how I got started, and I had the pleasure of working for a variety of different companies. Went from Intermedics to being at iOLab and then from iOLab to Alcon where I spent the 1990s really prospering and building out the AcrySof product line. I left ophthalmology for a while, was the Chief Technology Officer at Ethicon, and then was recruited by a bunch of my J&J friends to take Bausch + Lomb private. I was the head of R&D for Bausch + Lomb. Left ophthalmology again to go and be the Chief Head of Research for Boston Scientific. I did that for a while and then did some other roles until finally I ended up as the FDA where I headed up the Office of Device Evaluation, and I did all the medical device approvals for the US. That was a wonderful opportunity.
Did a few other different roles, and then I spent a couple years chased home by COVID, working within the Agarwal Eye Hospital system in India, developing a portable perimeter. I’ve had the pleasure to work in healthcare my entire career in and out of ophthalmology, but ophthalmology has always been my first love. Thanks for asking, Mark.
Mark Dlugoss:
Well, the saying goes in the industry, once you’ve been in ophthalmology, you never really leave. Sort of like the Hotel California.
John W. Sheets, PhD:
You can leave, but you can’t check out.
Mark Dlugoss:
Exactly. Let’s talk about Pantheon Vision before we start getting into the product you’re developing. Pantheon Vision was basically conceived last fall of 2023. Can you provide me some background on how the company came about? What was the driving force to say let’s start a company to provide new alternatives to corneal transplants?
John W. Sheets, PhD:
Sure. The history really goes back to another organization called KeraLink International that at one time was the dominant eye bank for all of the mid-Atlantic states. In 2018, the leadership there decided they really weren’t having a big impact on solving the problem of corneal blindness by being an eye bank. They ended up selling their company to what had now CorneaGen, raised a large amount of cash, and then they did a pivot to become a philanthropic organization dedicated to curing corneal blindness. When they studied what the opportunities were for where to make an investment, they found that the biggest investment they could make is to have an alternative to tissue transplants to repair damaged corneas. That’s what was the genesis of Pantheon Vision.
Initially, they had some ideas on some technologies they had been looking at. Those didn’t pan out, so they asked me to put together a company that could evaluate all the possible technologies to develop a substitute for the tissue transplants. Fortunately, going back to my time in graduate school, I did a lot of work on corneal materials back then, and of course, the Department of Ophthalmology at the University of Florida was very engaged in those kind of product developments back then. I benefited from that background, and we began to look at different potential materials to work with. That was the genesis of Pantheon Vision. We cast a very wide net looking at various materials and approaches, narrowed it down to the top 3, and we’ve been evaluating those for the last 9 months that we’re kind of ready to start making a decision now on what product we’re going to go after.
Mark Dlugoss:
The market of corneal transplant market has grown quite a bit in the last 20-30 years, and there’s a lot of big players in there, including some of the companies you’ve worked for in the past. Where do you see Pantheon Vision fitting in this market, and what are your expectations as you enter this market?
John W. Sheets, PhD:
I think it’s been a relatively neglected area. There hasn’t been as much investment in corneal treatments as there have been in refractive surgery or cataract surgery or vitreoretinal surgery. We’ve gotten a little complacent, I think, with the fact that tissue transplants were an available option for us to look at, but the whole space has ignored what were the broader macro-environmental activities going on in all of healthcare.
One of those is trying to reduce the cost and skill requirement for doing different procedures. There’s been an immense investment in cataract technologies to get to the procedures that are done today. We do high volumes routinely in less than 10 minutes per procedure because of the great partnership that has occurred between industry and the clinician. Where the innovations that clinicians find, going back to all of the people that were involved in different lens designs, the development by Charlie Kelman of phacoemulsification, that all the techniques that came out following that. That what drove cataract improvements.
That unfortunately has not occurred in corneal transplants. There’s been innovations. The eye banks have made great strides in extending their network, doing things to process the tissue to make it available to clinicians, both for PKs and DALC and for DMECs. But there hasn’t been a similar investment in all of the basic technologies to make the procedure more widely available. Our great institutions continue to train corneal specialists, but there simply aren’t enough globally available to address the great needs that exist.
Our investment in the technology is not just to produce a product that will perform better for the patients, but also a procedure that will have more controls and easier to do on the behalf of the clinicians.
Mark Dlugoss:
As part of your initial stuff, as you mentioned, Pantheon Vision has received a lot of funding from KeraLink International, starting with $2.3 million and just recently up to another $1.5 million and now to a total of $4.3 million in funding. KeraLink obviously has a strong commitment to what Pantheon Vision hopes to develop with this approach. Can you outline what care vision sees in your venture and have you received other inquiries into investment opportunities to your company?
John W. Sheets, PhD:
We have gotten inquiries from others. We’re actively fundraising because we need to raise a Series A that is going to take the product from where we are today through our clinical studies into commercialization. We’ll be soon announcing that Series A funding round that we’re going to be going after, but we’re going to need those additional monies to be able to afford that clinical study.
One of the things that comes from my broad industry experience as well as working at the agency, we’ve already had 2 valuable pre-submission meetings with the FDA, met with people from the ophthalmic division. They’ve given us great feedback on our plans, on our product designs. We’re in constant dialogue with them. We’re very appreciative of not only the support we’ve gotten financially from KeraLink, but also the advice we’re getting now from the FDA.
Also, we’ve had meetings with notified bodies relative to certifying our quality management system, so that concurrent with getting FDA approval, we can CE mark the product and then with the database that we create from our preclinical and our clinical work, we’ll register the product globally.
When we look out and project where our product sales will come, probably two-thirds of the dollar sales will come from the Western developed markets. But two-thirds of the volume of sales in terms of units will come from the low and middle income countries where they don’t have tissue banks. There’s profound needs for a treatment for corneal blindness. We need to get this product to those people. There are 13 million patients awaiting treatment today. We do 200,000 corneal transplants a year globally, but we get a half million new patients every year. In terms of a battle, we’re losing this battle. We need new treatment capabilities. That’s what Pantheon Vision will begin to market with its new implants.
Mark Dlugoss:
I know you’re in the process of developing both your scientific and advisory boards. Who has Pantheon recruited to this point, and in your recruitment process, are there any qualifications that you are specifically looking for?
John W. Sheets, PhD:
In our medical advisory board, we have 3 very qualified clinicians that are all board-certified corneal specialists. We haven’t publicly announced their names. We will be doing that soon, but they were people that all have great clinical experience in this space. They turn out that are all 3 very close friends, which helps us a lot. They also have a lot of FDA experience that will help us with our registration. That’s the qualifications we look for at the start of our medical advisory board. We’re also in dialogue with a variety of global surgeons that we’d like to add at some point to our team as well.
The scientific advisory board, I’m afraid to say, they all have the misfortune of having been colleagues that I’ve worked with in the past, and I brought them onto the scientific advisory board because of that close association and my great trust in their creativity and scientific ability. Again, we haven’t publicly announced those members, but it’s a group of people with great industrial experience as well as academic experience that range not only from ophthalmology, but also we have an orthopedic surgeon that has a lot of regenerative medicine experience. We have a former colleague that also was one of the seminal people in creating the regenerative medicine industry back in the 1990s. These kind of people are part of our team that we count on for their creativity. Now as we’ve surfaced a variety of candidates, their insights help us narrow down and pick out what is going to be the primary product we want to go forward with.
Mark Dlugoss:
Sounds like you’re moving in the right direction.
John W. Sheets, PhD:
Yes, sir. We’re very fortunate. When we added up the total amount of experience of these teams, we have over 300 years of experience.
Mark Dlugoss:
Let’s talk about Pantheon’s plan to corneal implant. It was recently reported that Pantheon Vision was looking at a multiple approach to develop a product that provides quality optics with superior functionality. Can you provide viewers with a little insight about the new implant and how Pantheon Vision plans to incorporate a multiple approach in developing it?
John W. Sheets, PhD:
The approach was all designed to be answers to what we described as our target product profile, and there were 3 elements in our target product profile. First, we want to get better vision. In all of the years I spent working on IOLs and refractive surgery, there were a number of other factors that people considered. Let’s get the IOL in through a smaller incision. Let’s make it a certain optic size. Let’s make sure that we have a particular UV cutoff on the material. All of these have been trends that came and went. The overall performance attribute that you have to provide is better vision, and we think that this is a big opportunity in a corneal transplant. The tissue transplants that are available today, even after a successful surgery, 52% of the patients have worse than 20/70 vision. Restated, that means they’re still legally blind after a successful surgery. We don’t think that’s an adequate result.
Similarly, we look at the durability of the implant; 11% fail at 1 year, 50% fail at 5 years. There’s not an FDA-approved medical implant that has that kind of poor performance. Knowing what we have to do to get this product approved, we’re shooting for much better performance than that with our product. Last, as I mentioned earlier, and this was one of the great lessons I learned at Alcon with the Alcon approach to having soup to nuts at everything that each surgeon, whether it be a cataract refractive or vitreoretinal surgeon is, if you control all of the variables that go into the surgery and you make sure that they work together in harmony, you can control the outcome better.
That’s what we want to do here. We want to control the outcome of these surgeries. We want to get better clinical results. We’ve got approaches. The eye banks that exist providing human tissue, they do a fabulous job, but they don’t make instruments for the procedures. They don’t make the sutures to anchor the procedures. They don’t make the other ancillary devices that are used. We’re targeting doing that, and fortunately, we’ve got members of our team that have deep experience in doing all of those things.
Mark Dlugoss:
Most bioengineered corneas are made of a collagen protein type. Is Pantheon Vision’s implant based on the same principle or is it completely different?
John W. Sheets, PhD:
It really is completely different. We’ve looked at a variety of using biological source materials for our product. It’s certainly one of the candidate materials we looked at, but we think that there are so many shortcomings that come with that. Most notably is you have to provide a sterile non-inflammatory product that’s available globally. Whether you source porcine pig cornea or collagen or whatever, there’s going to be a region of the world that won’t accept it for use. We’re looking to have a global product, so we’re kind of tending toward using synthetic materials.
Then the synthetic materials we’re working with, we’re trying to do two things that seemingly are not compatible with themselves. We want to have a novel material that hasn’t been used before, but we want a material that has proven biocompatibility. The candidates we have possess both of those characteristics. They’ve been in use in the body and they’re shown to be non-inflammatory, stable biocompatible, but nobody’s used them at date for corneal implant. That’s where we’re creating a lot of value with the novelty of what we’re doing.
Mark Dlugoss:
It’s a pretty all totally brand new, different concept and approach to corneal implants. Wow, it sounds exciting. As we know, corneal transplant surgery is the gold-standard procedure for addressing corneal blindness, yet significant improvements are still needed. Graft acceptance, vision restoration, tissue longevity. Could you outline how Pantheon’s approach may address these needed improvements?
John W. Sheets, PhD:
Part of it is since we’re using synthetic materials, we’ll be able to control more of the features of the performance of the product, how we fabricate them. Then when we have a product that’s sterile and in the package, it’s going to be stable for years. We’re projecting out to start going to market with a product that has at least 2 years of shelf life and we’ll end up with one that has 4. We’ll start off as we typically do in any ophthalmic product with a limited range of powers, and then we’ll extend it. All of those things will end up giving us better aggregate clinical results.
There’s a lot for us still to learn. We’re very optimistic based upon what we know about the materials and the product designs. We’ve got first-class people that I know have proven experience and capabilities, but when it comes down to it, we won’t know for certain until we get this product into the first patients in our clinical study. We’re very excited about moving it to that point. I’ve had the benefit of having done this multiple times in my career where we took a brand new material into a new application and tried it in clinics. It’s a tense moment. I generally don’t sleep the night the first patient has been implanted. But the excitement that comes with seeing a patient that comes from their exam and they find out how much better their vision is … This is a product that going back to our LASIK experience that will definitely have the wow factor. That these patients will have being be able to see for perhaps the first time in years when they come off the table.
We’re excited about that. But we also think that by having a procedure that is easier and faster to do than the current tissue transplants, we’re going to end up with a product and a procedure that the clinicians are excited to do. We want them excited and proud of the work they’re doing. They do such a fabulous job around the globe to restore people’s vision, this is just another opportunity for them to do that.
Mark Dlugoss:
What about risks and complications? Do you think that’ll be reduced to a lot of degree?
John W. Sheets, PhD:
Because we’re going to be able to provide a sterile product with more control in the product and the procedure, we think that lack of variability will help minimize complications that come from using tissue transplants today. Tissues come a long way in how they process it and how they prepare it, but it’s still taking a human tissue and processing it for use in another human. That’s not nearly as controllable as what we’re going to do.
Mark Dlugoss:
This past April 2024, Pantheon Vision requested early interaction meetings with the FDA, and you touched base on some of this, to obtain guidance on preclinical clinical work supporting your submission. Can you provide some more details about how highlights for those meetings, what kind of feedback did you receive and how have those meetings helped your company moving forward?
John W. Sheets, PhD:
I don’t mean to correct you, but we applied for those meetings at the end of last year. It generally takes about 90 to 120 days to get them scheduled with the agency with their busy calendars. We’ve been preparing for this all along. It comes back to the fact that in today’s world, the FDA may be looked at as the gatekeeper, but they’re really just the portal to moving forward with a lot of other processes.
We wanted to get early feedback from them about our plans, talking about what our indications for use were going to be because we know we also have to get reimbursement for this product. Not just in the United States, but around the globe. We wanted to begin that dialogue with them. There are multiple activities we’re doing now to continue that about reimbursement that are going to be critical for the success of the product. But we wanted to do that early.
In the words of the great Richard Daley, “Vote early, vote often.” We wanted to go in early and continue to talk to them about what their expectations were going to be. We believe that the responses we’ve got have been very critical. Again, I felt that way. My experience with Alcon, Bausch + Lomb and when I was president of HOYA, we talked to the agency whenever we could. But having been at the FDA, I’ve realized even more so how critical this was.
Your currency in dealing with the regulators is your credibility and each new group of regulators, and there’s turnover at the FDA like there is in any organization, you have to reestablish that. We wanted to make sure we created that going arm in arm with them on this process. There are very talented scientists, engineers, and clinicians. We engage them and respect them because of their commitment to the American public and health. That’s what we’re counting on as we go forward.
Mark Dlugoss:
I think it’s always a good approach to keep FDA in the loop whenever you can because this makes things easier for both you and the FDA.
John W. Sheets, PhD:
Absolutely. One of my responsibilities when I was at the agency is I was the primary person that handled appeals. When a sponsor was unhappy with the response they got from the agency, they had to come and talk to me. Of course, I was supported by the review teams that had considered the sponsor’s application. In so much of those dialogues, the primary issue was lack of clarity of communication between the sponsor and the agency. I have to say, in defense of the agency, a lot of times it was the sponsors were not clear on what they were saying to the FDA, and they weren’t understanding what the FDA said to them. Without disclosing anything confidential, there was a case where this sponsor from Europe came in and they were adamant that they had provided all of the data that was needed. They talked about there are 120 data points up on this chart showing our data and how the veracity of what their conclusion was.
I just simply counted the number of data points, and I said, “I count 40. Where’s the other 80?” They panicked, they huddled, they came back, “Oh, well, we’ve got the rest of the day, we can send it to you.” I go, “Guys, I’m sorry. You didn’t provide what was asked. Resubmit.” We came to a conclusion. But that’s the kind of rigor you have to count on. As an American healthcare consumer, I want the FDA to hold our sponsors and the industry to that kind of rigor. I certainly did when I was in leadership roles in different healthcare organizations, including Pantheon. We’re going to be rigorous and be data-driven. That’s what we have to do.
Mark Dlugoss:
Now that the groundwork appears to have been set, where does Pantheon Vision go from here as the company prepares for the move from a concept into clinical trials and eventually commercialization? Where do you go from here?
John W. Sheets, PhD:
A lot of it is in our fundraising discussions. We’re going to have dialogues with potential future partners. One of the great things about this product is it’s going to be used by the cataract and refractive surgeons that happen to be the corneal specialists that do the majority of the surgeries here in the US. As I go back and I talk to the companies I used to work with, whether it be Alcon, J&J, Bausch + Lomb, or a plethora of international companies, I get a chance to get them to think broader about their product lines. Hopefully, there’ll be an opportunity for us to collaborate with 1 or more of those companies.
But perhaps what we’ll also do is generate an appreciation that this is a huge unmet need in ophthalmology. That tissues just are not going to be the secret to providing an answer for corneal blindness. If what we do is end up generating competitors, welcome to the game because competition is what makes ophthalmology great. We have great competition with all of the different companies that are in the industry. We have competition between clinicians that try to invent new technologies to further their procedures. Where would we be if it was not for the great competition that happened between Alcon and Bausch + Lomb in vitreoretinal surgery driven by Steve Charles and Gene Dewan back in the 1990s? I mean, what a privilege it was to watch that competition and see 2 immensely talented clinicians do the amount of innovation they did and all of the names that did the same thing in cataract and refractive surgery, they’re too long to list them all. But that competition is what we need to see in cornea as well, and it’s not just around LASIK surgery. It is this need where we have corneal blindness that is crippling so many patients.
Mark Dlugoss:
In our discussion today, we covered a lot of information about Pantheon Vision and the company’s new implant. Are there any points of discussion we may have overlooked or is there anything that you would like to add regarding the company and its planned implant?
John W. Sheets, PhD:
I just want to go back and talk about my gratitude to KeraLink International for recognizing this need and providing the funding they’ve provided to date. My board of directors is composed of KeraLink International board members, including their new CEO Michelle Bockman that just joined. Very talented group of executives that are helping us stay the course on our track and continue to support us. But with that, I’d like to say is we’re looking for a continual investment in our Series A. We’d be interested in talking to anybody that has an interest in really addressing a big unmet need in ophthalmology with corneal blindness.
Mark Dlugoss:
John, sounds like you got Pantheon Vision running in the right direction, and it sounds like I’m looking forward to seeing how it all progresses down the line.
John W. Sheets, PhD:
Thanks so much and thanks for the time for this discussion today.
Mark Dlugoss:
That concludes today’s Ophthalmic Project podcast. I want to thank John Sheets for spending some time with me discussing Pantheon Vision and his plans for developing new alternatives in corneal transplant surgery. I also want to thank you the viewers for watching. I hope you’ll come back and join us for the next edition of The Ophthalmic Project. Have a good day.
