Emptying the OIS Reporter’s Notebook After OIS@AAO

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OIS Correspondents Michelle Dalton and Richard Kirkner pool their insights on the most compelling sights and insights of OIS, Subspecialty Day and AAO. The two scribes opine on exiting new disease targets, advances in drug delivery, the penetration of digital technology and why the `Pfizergan’ deal makes sense for ophthalmology.


Tom Salemi: Hi, everyone, welcome back to the OIS Podcast. This is your host, Tom Salemi. Thank you as always for joining us. Today, we’re going to do something just a little bit different. Actually, it’s something we started last spring. It’s a media roundtable. This year, I’ve invited two contributors to the Eye On Innovation Newsletter. Very happy to have the words written by Rich Kirkner and Michelle Dalton. Both have been covering ophthalmology for over two decades, each of them have. So they bring a great deal of insight and expertise into our coverage, and again, very thrilled to have them as part of our team. Both will be contributing content for the OIS.net newsletter when we put up our company profiles and our coverage of the day. A lot of that comes from Rich and Michelle. Rich Kirkner is the editor of the Retina Specialist Magazine. He’s also contributing editor of Managed Care Magazine. And Michelle Dalton, she has her own firm, Dalton and Associates. They write clinical manuscripts, medical education materials, newswires and trade publication articles, and of course coverage for the Eye on Innovation Newsletter. Happy to have Rich and Michelle here just to share some of the more exciting things they saw at OIS, both in biotech and device, as well as digital. Both of course were at AAO and brought home some interesting points of view on those days, including the subspecialty day on the Friday after OIS. So we’ll hit upon all of those areas, the things that they found most interesting. And of course, we’ll talk a bit about the Pfizer Allergan merger. So I hope you enjoy this little sort of roundtable discussion. We’re going to be getting to peer into the notebooks of two veteran journalists, and very happy to have them on the Podcast. Let’s have a listen.

TS: All right, Rich and Michelle, welcome to the Podcast.

Michelle Dalton: Thank you.

Rich Kirkner: Thank you, Tom.

TS: It’s great having you here. I know folks listening probably recognize your names from the Eye on Innovation Newsletter where we’re lucky to have you contributing content to that. So this is another forum to do that, so it’s great to have you here. And you both covered OIS Force. I know you each took on writing about the individual companies that were there, and you were involved in the coverage that is upcoming of our breakfast sessions. We’ll be putting out a report on that hopefully early next year, at this point, in January. What sessions did you sit through, and what were your couple of takeaways? Michelle, can you start out?

MD: Absolutely. I sat in on the dry eye breakfast, and obviously as most attendees are aware, we were all hoping that the Shire compound, Lifitegrast, would have received FDA approval by now, but it has been resubmitted instead with a new PDUFA date of April 16, I believe, next year. So hopefully, when we reconvene again at ASCRS, we’ll have some good news and a second entrant into that market. But overall, the takeaways that we were finding is the panelists really kind of believe that there is now a shift coming from the FDA, whereas they might be a little more lenient now instead of insisting on both a sign and a symptom, that it may be a one and done, whether it’s improving a sign or a symptom in order to get more products onto the market in a more timely manner, so to speak.

TS: That’s great. And regarding Shire, I mean they did have a bit of an up and down time a couple weeks before AAO. Is there a sense, though, that this is going to happen, that it’s just a matter of time? Or is there a feeling out there of uncertainty and people unsure as to what will happen with Lifitegrast?

MD: I think the ophthalmic community is pretty much certain that it’s going to be a done deal. Because the compound is under FDA review, Bob Dempsey was unable to speak about anything to do with Lifitegrast, understandably. But I think the general feeling in ophthalmology is that this is not only a needed compound, but it’s a very efficacious compound, and it will certainly do wonders once it’s on the market.

TS: It’ll be great when it happens. Rich, which session did you sit through? What were your takeaways?

RK: I sat in the combination therapy session for retina with Pravin Dugel and Don D’Amico of Columbia University. And the takeaway there is that it seems for AMD and diabetic macular edema, the paradigm, as Dr. Pravin Dugel said, the paradigm is really changing, that the anti-VEGF therapies are – they’ve made great progress, but that treats only one pathway in the disease cascade. So they reviewed a number of studies. I’m looking at 11 different clinical trials ongoing that involve some – one of the big 3 anti-VEGF agents, and a number of other therapies like Fovista, which acts on the PDGF pathway, a couple studies looking at PDGF, and also the molecular partners with their DARPin therapy. So it seems that probably in the next year or so a number of these clinical trials are going to show results, and we could have commercial approvals in late 2016, 2017 on some of these combination treatments.

TS: I sat through the gene therapy session, and there’s obviously a lot of hope around Spark there. You folks have covered ophthalmology so much longer than I have. Is there a real – it seems like there’s a lot going on. There are a lot of potential products coming out, there are a lot of hopeful clinical trials coming together. From your perspective, is this really coming kind of a golden age for ophthalmology? Michelle? I mean you’ve been covering this sector for a bit.

MD: I do think it’s heralding in a new golden age, if you will, in that I think the 90s and the 2000’s were diagnostics. And I think as we’re heading into the 2010s and 2020s, I think it’s going to be more on the pharmaceutical side. But a pharmaceutical side that is not typically just one compound. I think it’s going to be moving more into the gene therapies, not only for retinal disorders like Spark is doing, like you had just mentioned, and some of the companies that are working on various AMD or DME projects that Rich was talking about, but also in front of the eye stuff. When you start talking about some of the nanotechnologies and various [depots?] and sustained release compounds that are being – I mean the compounds are already there, but the way that they’re being delivered into the eye to reduce patient burden will hopefully come to fruition. So yeah, I do think this a coming of age. I just think it’s a technology coming of age, and how we’re able to manipulate that technology into smaller and smaller devices or encapsulated drugs to be able to deliver more efficacious treatments across both anterior and posterior segment disorders.

TS: Rich, from your perspective, are we seeing – is this really – I loosely use the term golden age. I don’t want to apply that to it, but there does seem to be a lot of good news going on in ophthalmology. What’s your take?

RK: Well, when you look at back of the eye treatments, and where it was, where they were ten, 15 years ago, and talking about photodynamic therapy, and then at the time the anti-Trap, which became anti-VEGF treatments, and that was pretty much – that was pretty much the universe of pharmaceutical retinal treatments at the time. And now, it just seems to have exploded as the clinical science has advanced, developing based on a deeper understanding of the disease pathways. But also, you know, you mentioned the genetic technology. I think with having a better understanding and more advanced models for developing genetic treatments, that has really pushed retinal therapies into a new direction that I think ten, 15 years ago was unimaginable.

TS: That’s fantastic. There’s a lot of excitement around the area, obviously, and that’s the point of OIS and just highlight all of these innovative ideas. Let’s just walk through some of the companies that you wrote about for OISl.net. We’ll be putting up the videos and descriptions that you folks contributed very shortly. Rich, why don’t you start off? What were some of the company highlights that you walked away with?

RK: Well, I guess looking at themes, there were two areas that you didn’t hear much about in past OIS’s. One was – is ocular melanoma, and another is Stargardt disease. Ora and Iconic Therapeutics are developing treatments for ocular melanoma. Ora has their clinical proof of concept due in the first quarter of next year. And Iconic is looking to file its IND for ocular melanoma sometime next year. So those are – that’s one area we didn’t hear much about. Another, like I said, was Stargardt disease. A couple companies looking at developing therapies there. Ocata Therapeutics and Acucela, and I may have even missed another one that’s working in that area. But again, these are diseases that – you know, at one point it seemed back of the eye treatment was basically AMD and DME, and now it’s getting into all these other areas. Looking at ocular melanoma, there are probably 10,000 people a year who get that in the United States. But I think one thing that’s advancing this area is the FDA policy, I guess, for lack of a better word, its orphan drug initiative. And its fast track initiative for breakthrough treatments, even though they serve small populations. It’s making it more appealing for researchers and investors to go into areas such as ocular melanoma and Stargardt.

TS: We highlighted Ora a couple of weeks ago on the Podcast.

RK: Right.

TS: And ocular melanoma is definitely one disease that is dire need of a better treatment. So it was great to see progress there. Michelle, how about on the device side?

MD: On, the device side, as I was saying before, I think what we were seeing a lot more of at OIS was companies slowly but surely taking yet another step forward in device delivery. It’s no longer going to be just a topical treatment or an injection, but now we’re looking at ways to encapsulate compounds that we already know work in anterior segment diseases or glaucoma or what have you, and looking at ways of encapsulating them so that they can become true sustained delivery, which again is going to come back to reducing treatment burden on the part of the physician and on the part of the patient. And hopefully these things will come to fruition. But it was exciting for me to hear about how everyone is starting to look at this in the diagnostics – or I’m sorry, in the device area, and really are – I mean they’ve moved beyond just a paper and preclinical stage. These are now companies that are moving in towards phase 2 and possibly towards phase 3. In general, presbyopia is still a big, huge unmet medical need. And you know, there’s now there’s a second inlay that has been submitted for FDA approval. That was the ReVision Optics Raindrop. So that will be kind of exciting. AccuFocus already has the camera and it’s moving into its IC8 IOL, which is granted it’s a small aperture optic and it’s not quite for presbyopia, but still it’s just a very exciting to look at what the device manufacturers are doing and how they’re trying to address all these unmet medical needs.

TS: That’s great. And how about the digital space? Rich, you covered a bit of that, correct?

RK: Yes, I did. And there were 5 companies this year that presented on the digital space. And Gobiquity is – their focus is on amblyopia. They’ve developed a couple products for that. And an interesting technology is from Ambliotech, which is using gaming technology to treat amblyopia. Amblyopia, the standard of care for amblyopia treatment, lazy eye, is the patch right now. And it just struck me that using gaming technology to train the eye is 0- just struck me as extremely innovative, especially when you consider how children must take to that kind of a treatment. You talk about a user friendly treatment, I can’t think of anything more friendly than gaming technology for children.

TS: No, not at all.

RK: I mean it seems like such a natural. There are a couple of other areas working. Home monitoring is always – has always gotten a lot of interest in the digital space in ophthalmology. Being able to do things like monitor intraocular pressure remotely, which I think is still a challenge out there, but also follow Amsler grid testing remotely for people who are suffering some form of vision loss. That seems to have a lot of potential. Although I have to say this year it didn’t seem as though there was as much on remote monitoring at OIS as last year, and maybe that has to do with that specific space maturing somewhat. But there – I mean digital technology, it just seems as far as ophthalmology goes, has a lot of upside potential. MD Backline using cloud based modules for eye care, things like dry eye and glaucoma, they have partnerships with AMO, Allergan, B&L and Alcon and Practice. And they’re looking to add platforms across a number of different disease states. So that’s one to keep an eye on. And then Alphaeon, which has done quite a bit in the private pay space, launching their direct consumer advertising and what they’re calling a social commerce platform for MDs to participate in. So there’s quite a bit going on in the digital space in ophthalmology.

TS: And Michelle, you said that carried over to AAO as well, that there was a lot of interesting applications involving the iPhone?

MD: DigiSight has a camera-ish or kind of a microscope that they attach to the iPhone that allows you to basically transform your iPhone into an OCT. And all the data is stored immediately up on the cloud so there’s no HIPAA issues in terms of having any of these actual patient photos on your phone itself. And that to me was – that was a kind of very, very interesting company. I’m pretty sure that they went into great detail when they presented at OIS on their products as well. But to me, that was a way of really starting to use phones as the small computers that they really are.

TS: Yeah, no, we’re seeing digital technology moving into healthcare, and it’s moving, it seems, more deeply in ophthalmology than anywhere else in terms of real clinical applications, not so much the fitness tracking or even the blood pressure stuff is coming someday, but it’s not quite here yet. So it’s exciting stuff. What else happened over the weekend after OIS?

MD: Well, if I can just bounce back onto –

TS: Oh, yeah.

MD: – to what you were just saying, Tom, I do agree with you. I do think it’s being embraced much more so by ophthalmology than it has in some of the other medical specialties. But I also think that ophthalmology in general tends to be one of the early adopters of technology overall. I mean at one point in time, we were sitting in the OIS audience of almost 1000 people, and I’d say a good 50% were wearing an Apple Watch already. You know, that’s –

TS: Good observation.

MD: – I don’t know if you went to a group of podiatrists if you would see the same thing.

TS: I don’t know. We’ll have to see if we can set up a PIS and see what kind of crowd we get there. And as far as AAO, what did you hear that weekend?

MD: Well, aside from obviously the fact that Alphaeon has bought Lensar, that was the big news. And then the rumors about the Pfizer Allergan deal started while we were still there, and obviously as we all know, came to fruition after we left AAO. But while at AAO, I think some of the highlights again go back to what you guys had already – what we had already seen, rather, at OIS, which was just a lot of talk about nanotechnology and sustained delivery and extended delivery, at least in the sessions that I was sitting in on. Hopefully, Aerie’s products come to market, and that would be great, and that the glaucoma market hasn’t seen a new compound in probably what, a little over 20 years since the last one was approved. So that’s got the glaucoma people all excited. There’s some delivery – there are some delivery companies that are looking at how we can target delivery to the suprachoroidal space. That’s also going to be interesting, presuming that they get to move ahead from phase 2 into phase 3, and that those trials are successful as well. But this year for me was a lot more of the midrange studies, more like the 2a, 2b studies much more so than the phase 3 study results being discussed upon on the podium.

TS: Great. And Rich, you made it over to – I’m sure you both made it over. Can you give us a sense of what happened in subspecialty day?

RK: Yes. At retina sub day, I mean my favorite part of that is always the late breaking developments where they’re talking about results from ongoing clinical trials and top line results from phase 3 trials as well. There were a few that stood out, and where this seems to be going is extending the time period between anti-VEGF injections. There’s a lot of study into doing different things to, instead of doing monthly injections, doing them less frequently because ophthalmologists and retina specialists realize that the treatment burden is real difficult for some patients. The Oasis study came out, ThromboGenics ocriplasmin. Peter Kaiser discussed results of that for treatment of VMA and VMT, including macular hole, which is another area where it seems treatment is, again, is going beyond AMD and DME and into other areas. But there was also the treat and extend therapy for the Atlas study. Carl Regillo discussed the 2 year results from that. And the results look promising for that. So a lot of different things going on. Trying to extend that time period between injections. A couple other things. I learned from Genentech that they are working on the Ladder study, which is a Ranibizumab port delivery system, which again, they’re trying to adjust the treatment burden there. And Michelle had mentioned the suprachoroidal space. I know Clearside has made some progress there.

MD: Exactly what I was thinking about, too.

RK: Yeah. In getting, again, getting drugs, getting drops from the front of the eye into the back of the eye. And if they can solve that dilemma, that would really address the issue with treatment burden substantially.

MD: Absolutely. I wholeheartedly agree with you, Rich. I mean it would – it means instead of patients having to come to the retinal specialist’s office every month for injections, they can go twice a year or three times a year. And that is just – it will expand the number of patients that these retinal specialists are actually going to be able to treat and see, and reduce patient treatment burden, which everyone has been talking about is going to become very problematic down the road. And one of the things that I thought was also interesting that we didn’t really touch on so much was the DRCR’s latest protocol S results that came out, which for the first time to my knowledge, anyway, showed a non-inferiority – showed basically that anti-VEGF was just as good as laser treatment in proliferative diabetic retinopathy, and without the bad side effects of peripheral vision loss. And I thought that that’s something that, you know, moving forward is kind of good, that we’re finding more and more ways of treating these diseases without huge side effects, and without saving vision in one area to lose it in someplace else. And I thought that that was one of the highlights for me, anyway.

TS: That’s outstanding. And we hit upon it a little bit earlier, but the Pfizer Allergan conversation that obviously cast a large question mark over the proceedings. Not so much, I think people assumed it was happening, but no one really knew what shape it would take. There’s a feeling that with Brent Saunders as CEO that ophthalmology will remain a primary or at least an important part of the new Pfizer. What are you folks hearing, and what’s your take away from that? Rich, why don’t you take that one?

RK: Well, I think besides the fact that Allergan has its headquarters in Dublin, which seems to be a big motivating factor for Pfizer –

TS: Sure.

RK: – but getting – Pfizer getting a major play in the ophthalmology space, I think that is appealing to them because, as we’ve talked about, I mean there is a lot going on in the ophthalmology space. And as you know, with big pharma, big pharma has moved from having these massive research campuses to more farming out their research and licensing developments from smaller companies. And that’s one thing I read in Bloomberg was about how the contract research organizations that Pfizer deals with, how they’re sort of expecting a small reduction in business, but after the merger becomes finalized, they’re looking at a considerable uptick in business. So while the combined company probably won’t spend as much as the two companies did in R&D, there is a lot of potential for R&D again in the licensing from smaller companies and in the contract research area as well.

TS: That’s interesting. And Michelle, I mean I was talking with Dick Lindstrom and he was sad to see potentially the Allergan name go, but happy to see Pfizer back in ophthalmology. Wishes Merck and others would follow suit. What are you hearing first about the deal itself, and then would you anticipate maybe others moving into this space? Is that a possibility?

MD: I think any big pharma that isn’t considering moving into ophthalmology is cutting off its nose to spite its face, to be honest. We are an aging population. Every data report that you see about how the world wide population is aging. Ophthalmology has a lot of age-related diseases that it treats, both front of the eye and back of the eye issues. As far as the Pfizer Allergan deal itself, things that I’ve been hearing and things that I’ve been reading is that where I think it will greatly benefit Allergan or Pfizer, Pfizergan or whatever we’re going to call the new company, is that Pfizer has a much, much stronger hold in the Asian markets, and a much deeper sales force present in the Asian markets than Allergan does, or the previous Actavis did. So I think that that’s going to be a huge opportunity in that you hear a lot of ophthalmic companies in the US these days saying how difficult it is to penetrate into the Japanese market, or to penetrate into the overall Asian market. And I think this is one way that for Allergan, anyway, I think it’s an absolute great idea for – or vehicle for them, rather, to be able to expand their business presence and their marketing presence with all their ophthalmic drugs, and that they’ve already got now a built in sales force.

TS: Yeah, that was something Brent Saunders hit upon in the analyst call more than once, the opportunity for growth in international markets. It’s definitely an exciting deal. Well, this has been a great overview of what was a really fascinating weekend, starting with OIS. Thanks for your contributions to our newsletter, and of course our OIS.net website. It was great to have you on the Podcast.

MD: Thank you, Tom.

RK: Thanks a lot, Tom. Appreciate it.

TS: Well, thank you Rich and Michelle for joining us. Rich Kirkner and Michelle Dalton. So happy to have you as part of the OIS team and thrilled to have you on this Podcast. We’ll definitely do this again following some future clinical meetings. But until then, make sure you subscribe to Eye on Innovation. Go to OIS.net, just give us your name and email address, and we will make sure that you’ll hear or see the reports from Rich, Michelle and our other great writers for the newsletter. Thanks again for listening to this roundtable discussion. Tune in next on the OIS Podcast for another tale of innovation in ophthalmology, and we’ll look forward to visiting again with you soon. This is Tom Salemi, and take care.