Duker Speaks to Cost Concerns, Other Challenges Facing Retina

Jay S. Duker, MD, is the Director of the New England Eye Center (NEEC), Professor and Chairman of Ophthalmology at Tufts Medical Center and Tufts University School of Medicine, is seeing much-needed increases in innovation for retinal disease, suggesting we’re at the “end of the beginning” of an epic rise in innovation.

Participant:

Transcript:

Tom Salemi: Hi, this is Tom Salemi at OIS TV. We’re here at OIS@ASRS. And I get to sit down again with Dr. Jay Duker, Director of New England Eye Center, back in Boston. Boston guy.

Jay Duker: Hello again, Tom.

TS: Hello again. Good to see you out here in the Bay Area. So this has been our first OIS@ASRS. I know we’ve seen you at our other OIS’s. Any takeaways from this first session?

JD: Yeah, it’s nice to see that the OIS is really concentrating on the field of retina, where there is certainly a lot of innovation, both in the biotech world and also the equipment world. So the takeaway is that there’s still a lot of innovation that needs to be done in the field of retina, and a lot of companies interested in doing it.

TS: That’s good news for the patient and for physicians like yourself.

JD: That’s correct.

TS: Retina has been a challenging specialty for a long time. We’re seeing the advances and one of the challenges when you have new products come out is paying for them. And you were on our Paying for Breakthrough Eye Therapies panels. First question: just any takeaway from the panels? You guys figured out all the problems yourselves?

JD: Obviously no. A lot smarter people than us haven’t been able to figure out the payment issues. But I think what’s happening really again, for all intents and purposes, the pharma world of retina is the anti-VEGFs. And approximately a $5 billion a year business in the United States and growing. And so that’s got the attention of the payers, even though I learned today that ophthalmology only represents less than 3% of the pharma bill for the country –

TS: Really?

JD: – that is a high number, 5 billion. And as a result, the payers are starting to implement things to try to lessen the payment burden on them. I do think over time there will be continued pressure to lower the prices of the anti-VEGF, not just from the payers, but from innovation. I think we’re going to see biosimilars and other type drugs come out that will put some pressure on the pre-existing anti-VEGFs to lower their prices. So I do think there will be a trend in that direction. I think against that will be drugs that are attacking new pathways: anti-PDGFs, tie 2 inhibition, angiopoietin. Those new pathways, if successful, then they are going to take a piece of the pie as well. And there’ll be new drugs with potentially new indications, and I think that they will be priced, I think, initially at a premium.

TS: How does the concern over costs impact you as a physician? Have you had to think about it before?

JD: We do. The concern over cost – so there’s a lot of levels to that. There is the individual level of a doctor in private practice who is a solo practitioner looking at their livelihood and saying how can I risk buying these expensive drugs when I really don’t make any money on it? I barely break even on the drug itself. I’m glad I have a less expensive alternative. To the societal costs, to the direct cost to our patients. Obviously, patient doesn’t have insurance, we’re going to try to choose the lowest paying drug that we can. So that’s not a simple question, and therefore it’s a complicated answer. In the world that I live in, an academic medical center in a state that’s had Romneycare for the last 10 years where virtually everybody has health insurance, it’s really been less of an issue, frankly, in that we can choose to treat pretty much with whatever drug we see fit. And that’s really, I think, the essence of the problem is physicians really want to have choice for their patients. And when payers start to come in and mandate that you must use a certain drug or another drug is not on formulary, I think that produces problems for most physicians.

TS: Well, we’ve seen that dynamic happen on the medtech side more.

JD: Certainly have.

TS: And we’ve seen what impact that’s had on innovation and investment in that sector. It’s certainly put a damper on things.

JD: It can. The good news again is there is a lot of innovation coming down the pike in the field of retina. And I think that those innovations will be paid for.

TS: Where do you think we are in the sort of moonshot effort to cure retinal disease? Very early stages?

JD: Boy. We’re at the end of the beginning.

TS: OK.

JD: But we haven’t quite gotten to the middle yet. The effort to quote-unquote cure retinal diseases, I mean they’re several fold effort here.

TS: Sure.

JD: And I think that the understanding of the molecular basis of disease and the genetic basis of disease is really important. And once you understand the basis of disease, you can start to tailor smart therapies towards that disease. But it’s a dance between diagnostics and therapeutics. In order to really tailor the individual therapy, you need diagnostics, whether it’s genetic diagnostics or imaging diagnostics to tell you exactly what’s going on at the cellular level or the genetic level. So I think we’ve just started to recognize the power of that. And we’ve learned that one pathway, the VEGF pathway is really a final common denominator for a lot of diseases. And I think that we may see other pathways, programmed cell death pathways and other things that we’re able to successfully treat and block a myriad of disease processes. So we’ve got a long way to go.

TS: That was a long way to go, and I know as soon as I said the question, I’m like, well that’s kind of a poor way to phrase it, but you’re right. We’re seeing so much going on, and the end of the beginning is an interesting way to think about it because there’s a lot of momentum now.

JD: There is.

TS: There are a lot of different entities looking to create cures for whatever we’re able to identify it at this point. Gene therapy is an area that has gotten a lot of interest, and I know you’re involved in a company, Hemera.

JD: That’s correct.

TS: And tell us a bit about the company and your approach.

JD: So Hemera is a preclinical company at this point, developing a gene therapy for dry age related macular degeneration. We’re using an AV2 delivery system and our target is complement. We have completed some IND enabling studies and we have had significant discussions with the FDA, and we hope to be filing our IND within the end of the year, and hopefully treating our first patient in the phase 1 soon afterwards. As far as I know, we’re the only company looking at gene therapy for dry age related macular degeneration. And of course the beauty of our approach is it possibly could be a one and done for some patients. In other words, a single intravitreal injection giving long term protection to patients who are at risk for geographic atrophy.

TS: That’s the kind of product, if you were successful in getting it approved, that I think would be – insurers would welcome it. Cost is a much less concern.

JD: We certainly hope so.

TS: How did you come to become involved with the company?

JD: There were several of us who are founders out of Tufts Medical Center at Tufts University School of Medicine. Rajendra Kumar-Singh, much of the work was initially done in his laboratory. My other cofounders are Elias Reichel and Adam Rogers, who are also retinal specialists at Tufts. And the four of us, after meeting many times over the science, really put together a plan to license the intellectual property from Tufts, which we’ve done, and successfully fund raise to get us through the preclinical work. And now we have enough funding for the phase 1. It’s essentially a virtual company, and it’s worked very well for us.

TS: Had you had experience in company creation before?

JD: No.

TS: No. So how does that illuminate you as a physician, to kind of see the other side of the business?

JD: Drug development is very difficult. That’s what I’ll tell you. It’s very difficult. And the ability to have a vision to start with a scientific concept and get it to FDA approval is a long, long haul with a lot of things that can go wrong. And even with great science and good minds behind it, and even add plenty of funding, it still doesn’t always go as expected.

TS: Sure.

JD: And so that I think the important things are to work hard, stick with the plan, but be pragmatic when the science guides you in perhaps a different direction.

TS: And final question: looking ahead to the next 2 years in the retina space, what successes do you hope we’re looking at OIS@ASRS in 2018? What milestones –

JD: Well, the most obvious ones I think have to do with new pathways. It’s been ten years that we’ve been able to block pathological levels of VEGF in the eye, and we’re doing it quite successfully. We’re on the verge, I believe, of FDA approval for blockers of other pathways which we hope will increase the visual outcomes for our patients. And that’s where I think the new innovations are mostly going to be in the next few years is FDA approval of medications for new pathways, along with alternative drug delivery.

TS: Drug delivery really is something that we need to talk more about, I think.

JD: WE do, but again, it’s not a trivial problem when you’re talking about long term protein delivery in the eye. If it was a trivial problem, the smart minds would have solved it already.

TS: No trivial issues here at OIS, only the big ones.

JD: No.

TS: Thanks for taking a few minutes here.

JD: My pleasure