Smarter Eye Care with Eyenovia Bio Pharma

Dr. Sean Ianchulev and Dr. Pamela Gallin discuss myopia and the positive results from its EYN PG21 proof-of-concept study demonstrating that its micro-dose of latanoprost successfully lowered intraocular pressure (IOP) and achieved patient usability.  

Dr. Sean Ianchulev, MD, MPH, Co-Founder, CEO and President of Eyenovia.

Dr. Ianchulev is a Harvard trained physician, eye-surgeon and Professor of Ophthalmology at New York Eye and Ear Infirmary of Mount Sinai. As an innovator and disruptive technology developer, he has been at the core of medical products and technologies which have transformed the ophthalmic field and are impacting medical care for hundreds of thousands of patients every year.

Dr. Ianchulev is a prolific inventor, innovator, pioneer and developer behind some of the most impactful sight-saving technologies and therapies approved by the FDA over the last decade – from Lucentis for Macular degeneration and diabetic retinopathy (Genentech), to intraoperative aberrometry for high-precision cataract surgery (Ora, Alcon), the first suprachorodoial micro-stent for glaucoma (CyPass, Alcon) and the first micro-internvetional technology for cataract surgery (miLOOP, Iantech).

Dr. Ianchulev founded Eyenovia in 2015 to revolutionize the treatment of eye diseases and create the first smart technology for high-precision piezo-print microdosing – a new way to take eye medication.Eyenovia is a clinical stage biopharmaceutical company developing a pipeline of eye care products made possible through a precise topical dosing approach.

Eyenovia makes new therapies possible. Its unique delivery platform uses breakthrough piezo-print technology for high-precision micro-dosing. Micro-dosing allows for fully effective therapies that may also avoid many tolerability and side-effect issues associated with traditional eye drop delivery.

Pamela F. Gallin, MD, FACS

Dr. Pamela F. Gallin is a Clinical Professor of Ophthalmology (in Pediatrics) at New York-Presbyterian – Columbia University Medical Center. She is a member of the Eyenovia Scientific Advisory Board.

Dr. Gallin is one of the highest-ranking female surgeons at NY Presbyterian where she is a Director Emeritus, Pediatric Ophthalmology and Adult Strabismus & Clinical Professor of Ophthalmology in Pediatrics NY Presbyterian-Columbia University Medical Center. She is the author of “Pediatric Ophthalmology”, a textbook used internationally. Dr. Gallin graduated from Washington University in St. Louis MD (Top 10%), AB, BS: Summa Cum Laude, Phi Beta Kappa and Tau Beta Pi (Engineers Phi Beta Kappa). Her Ophthalmology residency at The Mt. Sinai Medical Center (NY) was followed by a Heed Foundation Fellowship. She studied: Pediatric Ophthalmology (Marshall Parks, MD, Children’s National Medical Center and Dr. Philip Knapp, MD Columbia University Medical Center), Pediatric Ophthalmic Oncology (Robert Ellsworth. MD & David Abramson, MD) and Genetics (Irene Maumenee, MD).

Dr. Gallin graduated summa cum laude, Phi Beta Kappa, and Tau Beta Pi (Engineering Phi Beta Kappa) in Engineering from Washington University, St. Louis, where she received her medical degree in the top 5% of her class. Her internship at New York University was followed by a residency at Mt. Sinai Medical Center.

Transcript

Neal Howard: Welcome to this Health Supplier Segment here on Health Professional Radio. I’m your host Neal Howard, thank you for joining us. We’re going to have a conversation today with Dr. Sean Ianchulev, he’s a professor of Ophthalmology at the New York Eye and Ear Infirmary of Mount Sinai. And he’s joined today by Dr. Pamela Gallin from Columbia, and they’re going to discuss myopia here and the positive results from their recent proof-of-concept study. Thank you both for joining us today.

Dr. Sean Ianchulev: Thank you, it’s a pleasure.

Neal: Yes, Dr, Ianchulev, why don’t you give us a bit of background about yourself other than being professor of Ophthalmology, are you currently practicing or teaching or what is your role there at New York Eye and Ear Infirmary?

Dr Ianchulev: Yes, I do a practice part-time and teach at New York Eye and Ear. Until recently, actually I was at on the west coast at UCSF as an associate professor there for about 10 years where I did a lot of the same and have been involved over the years in developing new technologies in ophthalmology, all the way from the early days when I headed the development of Lucentis at Genentech. And more recently with micro … technology as well as inter… so I’ve been involved both on the device and the therapeutic development side and really collaborating with the industry as well as interfacing with academia to help develop and bring those new products to patients and physicians.

Neal: And Dr. Gallin, a bit about yourself?

Dr. Pamela Gallin: I’m a clinical professor of Ophthalmology at New York Presbyterian Columbia University Medical Center, I’m director of Meredith of pediatric ophthalmology and I’ve spent a professional lifetime teaching and seeing patients with a myriad of eye pediatric and adults with these eye problems but most recently in the last five to ten years I have become very interested in the fact that approximately 20% of kids in schools aren’t able to see the blackboard. Most of this in fact is from myopia. I am a consultant to New York City Department of Education and in fact the moving force behind the fact that New York State is now having Vision Month for the second year, approved by Governor Cuomo. In fact people do not know that kids can’t see. The progression of myopia is an epidemiological tsunami and it has not been brought to the attention of parents, educators and kids.

Neal: Dr. Ianchulev, talk about the differences between progressive myopia and I guess regular myopia, the normal myopia that we see around us on a daily basis.

Dr Ianchulev: Yes, that’s really a very interesting question. Both clinically and for us physicians but also for patients very often when people talk about myopia and I think the lay term that we use is nearsightedness and most people associate that with eyeglasses, in some cases people actually treating this as a benign problem with the refractive laser procedures such as LASIK and that is something that we encounter day-in, day-out all the time and most patients are quite veneers. Where things really break now and become different and it requires little discerning and again something that the awareness really hasn’t been there over the past few years and now that we see the Adamic really growing in the forefront is that progressive myopia or myopic progression is a fairly different disease and very distinct. There is currently no FDA-approved treatment for that and what it really means is that when you have progressive myopia like the nearside can be treated with glasses, in progressive myopia the eyeball actually stretches and and it continues to elongate to become bigger and bigger and this is a process that happens in young adulthood between the ages of 5 all the way to 20. And again, that stretching of the eyeball really has consequences and probably the simplest consequence is myopia but there are many other consequences especially when it continues unchecked for many years and it becomes rather large. The eyeball becomes longer then people get retinal detachments and we have actually patients who have really significant myopia as a result of progressive myopia, we’re telling them “Don’t get on roller coasters. Be careful with contact sports.” Again, this is a very different entity and it can result in really significant consequences such as retinal detachment, retinal atrophy and many others so I think that we need to educate both actually physicians and also patients about the differences in progressive myopia and nearsightedness which we see today and I’m sure Dr. Gallin has a lot of young adult patients who are dealing with that and it does require some additional education and insight.

Neal: Dr. Gallin,  do you think that a lack of additional education and insight is the reason why children aren’t routinely screened for this condition? Or are they routinely screened and just maybe falling through the cracks somehow?

Dr. Gallin: It’s multifactorial. Children on the books from the American Academy of Ophthalmology, the American Association of Pediatric Ophthalmology and the American Optometric Association – it’s written that vision screens should be done on annual exams in pediatrician’s office and as part of the health screening. Practically speaking, for a lot of reasons not to be discussed here, that does not happen. And so for example, in a recent study in an independent and an affluent independent school, 15% of the kids could not see. In New York City and I wrote a New York Times editorial on this, 20-25% of the kids couldn’t see but the vision screen programs in general are set up for pre-K, K, kindergarten and first graders. The idea that everybody entering school should have their vision checked each year is a somewhat radical idea. Until you die, until you determine or diagnose the problem, you can’t then go to fix it and identify further consequences so I really do believe it’s a national health issue that is not  being addressed because everybody assumes that the kids are being checked for vision, that’s not the case.

Neal: Dr. Ianchulev, you’re the CEO of Eyenovia. You’ve recently conducted a proof-of-concept study, talk about this study and talk about your founding Eyenovia as well.

Dr Ianchulev: Yeah. I’m very passionate about that because in a way the technology that Eyenovia is developing is really changing something on a fundamental scale and something that we really haven’t been able to address for many years. In fact, if you think about how we deliver not only when it comes to myopia and we can talk about some of the implications for myopia a little bit later, but for any other eye therapy that’s given in an eye drop form, as much as innovation that has been in many new therapies that we’ve developed over the last 100 years – they are all using the standard eyedropper technology from more than 100 years ago. The eye droppers look a little different but we’re still pipetting drugs into the eye and again there’s been many many studies more recently that show that about half of the patients can’t even get the eye drop, it either drips down the cheek or it’s just they cannot really get it inside the eye because it’s so challenging. Particularly if you’re a kid or particularly if you’re an elderly adult or you have tremor, you have arthritis – it becomes really complicated so half of the time, people are getting the imprecise dose. And then on the flip side of the coin, if you do get an eye drop in the eye, we’re still giving an eye drop which is about 30 to 50 microliters. And again, a lot  of us think about an eye drop is a very small quantity of fluid but in fact when it comes to your eyes, small things are measured on a different scale. Our entire tear film capacity is only 3 to 7, 8 microliters so even with a single eye drop, we’re overdosing the eye consistently by 300% or more and studies have shown that when even people get an eye drop in their eye, they’re actually put in 1 to 2 to 3 sometimes up to 7 eye drops. So again, we’re using a very imperfect, very legacy technology which has worked for us well but I think the day we want a lot more from precision medicine, a lot more for patient outcome. So I know this technology is unique because we’ve been able to shrink the inkjet printer technology that really revolutionized document printing and content and allows us to print on a piece of paper more pixels of ink. We’re using the same piezo printing technology to actually deliver micro droplet in micro quantities as much as 3, 4, 8 microliters on a completely different scale. And because it’s an inkjet printer technology, it does it very gently and at the same time very efficiently. It can go into the eye and coat the ocular surface in less than 80 milliseconds which actually beat the  blink reflex which is 100 millisecond so it literally beats the blink. And on top of that, it’s actually now connected with smart functions and technology that allows u to communicate with mobile  song and really record compliance data so that we can work with the patient and in the case with myopia, parents would know whether the kids are compliant with therapies that can decide saving. So this technology is groundbreaking in a number of ways and it particularly plays into myopia where now we know and actually there was a recommendation in technology review by  the Academy of Ophthalmology saying that there is now level 1 evidence and they rarely do that to say there is record level 1 evidence about a therapeutic but so many studies have shown that atropine therapeutic can slow down the progression of myopia by almost 60 to 70 percent. But the only way to achieve that is with very low doses so that you can prevent the consequences and sequela of side effects in those kids and that’s where Eyenovia’s technology really can help unlock that and deliver micro doses in a clinically relevant way so that we can really open up that therapeutic opportunity and make it relevant to our patients.

Neal:  Dr. Gallin, how can Eyenovia’s microdosing technology impact children and families in the clinic?

Dr Gallin: Very specifically, there are two parts. One is the ease of administration and two is the dose or amount of drug received. For the first part, kids do not like having eye drops of any variety in their eye. Even if they are soothing eye drops, they prefer not to take any eye Drop. With Dr Ianchulev’s technology, it’s a greater ease of administration, it’s less threatening to children and may I say, all patients. For the second part and children who are receiving a chronic medication, we’re always concerned that over a long period of time, young children whose bodies are forming or absorbing too much of the medication. One of the brilliant parts of this technology is the fact that the actual dose per drop or per application is much smaller so if you’re giving a child a chronic medication which would be the case in case of atropine for myopia or some other medications in chronically ill kids, you can this way administer a smaller dose literally and there should be fewer side-effects from the system in absorption.

Neal: Well where can we go online and learn some more about Eyenovia and this recent study?

Dr Ianchulev: So the study that we have will be, so we’ve done about three studies and the first two studies are already published and you can go on the Eyenovia website which is eyenoviabio.com and we have the studies there. The latest study, we actually demonstrate almost 90% efficacy of being able to deliver a micro dose which is I mentioned with the legacy technology of eyedropper being 40 to 50 percent – we’re really changing the game of that. So this data will be presented shortly and published I hope by the end of the year. We’re going through the peer review process but we’re very excited about that and a lot of the information and education information, you can find on really the website of Eyenovia. Or even if you search Google and you put the word myopia and epidemic, there is a lot of  recent epidemiologic data and resources available, including studies from Nature and other very reputable journals that  really help us focus in and de-pixelate that problem and start breaking it down so that we can  prevent what we’re seeing as an epidemic all the way from Asia to the US.

Neal: Well Dr. Ianchulev and Dr. Gallin, thank you Dr. Gallin, thank you both for coming in today on this Health Supplier Segment. It’s been a pleasure, lots of great information. Thank you both.

Dr Gallin: Thank you.

Dr Ianchulev: Thank you.

Neal: You’ve been listening to Health Professional Radio, I’m your host Neal Howard. Transcripts and audio of this program are available at hpr.fm and at healthprofessionalradio.com.au. You can also subscribe to this podcast on iTunes, listen in and download at SoundCloud and be sure and visit our Affiliate Page at hpr.fm

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