Episode Transcript
Speaker 0 00:00:00 Welcome to the dry eye coach podcast series. Click on dry eye. Your insider passed to the most exclusive dry eye topic. The series will raise awareness about the current and future state of ocular surface disease. The podcast will focus on a variety of topic before we get to our next episode. Here's a quick word from our sponsor.
Speaker 1 00:00:18 As a global specialized company, dedicated ophthalmic Santon brings a 130 year history of scientific knowledge and organizational capabilities to research development and commercialization of pharmaceuticals, surgical and medical devices and OT C care products. Sanon is the market leader for prescription ophthalmic pharmaceuticals in Japan, and its now reach patients in more than 60 countries. Santon provides products and services to contribute to the wellbeing of patients, their loved ones and consequently to society.
Speaker 0 00:00:52 In today's episode, we're excited to have our friend Derek Cunningham from Del laser consultants in Austin, Texas, to talk about steroids, the and where they fit in with dry eye disease. Welcome Derek.
Speaker 2 00:01:06 Thank you for having me.
Speaker 0 00:01:08 What kind of modality are you in? What is your patient focus? Let us let our friends know a little bit more about you.
Speaker 2 00:01:15 Sure. I'd be happy to, uh, we are a tertiary referral center for primarily surgery and I have ophthalmologists and for optometrists, we primarily rely on referrals from the community, uh, community optometrists and ophthalmologists and in, uh, being that, uh, uh, advanced surgeries is a large part of our business. We also had to branch out into a lot of dry eye care and research over the line several decades. And that's probably been in conjunction with the need to use steroids per surgically, our biggest involvement in the development and the implementation of these steroids and, and standards of care around steroids is understanding really how the eye responds, not only to acute trauma, which basically that's what surgery is, is acute trauma to the eye controlled acute trauma. You know, secondarily, there are understandings of chronic inflammation, which has really evolved over the last several decades and that's kind of the setting that I'm in and that's what, where, you know, my interest or my involvement in, in a lot of the steroid development has been in the last couple decades.
Speaker 3 00:02:23 Hey Derek, we're gonna talk a lot about steroids today, but you have a lot, I mean, with all the clinical research you do and all the procedures, can you tell us a little about, you know, your whole dry eye practice? What are some of the technologies you have, uh, when you're looking at your treatments?
Speaker 2 00:02:38 Yeah. You know, it, it's interesting. We dry is something I really don't like. And it was about 15 years ago that we did a, a, a detailed assessment of our patient satisfaction from primarily from premium IOLs, but also from LASIK or these, uh, presbyopic correcting IOLs. I hate the term pres premium IOL. And really what we found is that the vast majority of our unhappy patients were, were due to, uh, you know, basically dry eye or untreated dry eye. And, and we learned a lot in, in those retrospective analysis.
Speaker 3 00:03:10 Yeah. You know, when we did a lecture the other day, you know, I think one of the takeaways that the, the attendees got was anytime you're treating the ocular, you treat the inflammation, but you also have to treat the glands. Um, you know, any thoughts on that? Anything you wanna comment on that?
Speaker 2 00:03:26 Yeah, we actually had to change. We do just like wall your center. We do a lot of education for residents and, and interns. And I think the, the idea with dry eye is historically we thought it was overly simplified and that's why we weren't successful. And in, I think in the last decade, people have made it over complicated and that's why we're not successful. I mean, I'm complete, you know, this is one of the few things we're in complete agreement of. I tell everyone of my students before they come to me and tell me anyone has dry eye. They need to decide number one, what they're gonna do for inflammation and number two, what they're gonna do to manage the lids or treat the glands. And so every single dry eye patient has been broken down into two things. What are you gonna do for inflammation?
Speaker 2 00:04:05 And then what are you gonna do for the glands? And by doing it that way, it's, it's really distill it down to something deadly simple. You know, I make, I really put it akin to glaucoma. If you look at glaucoma, as complicated as we all make glaucoma seen, it's probably the easy disease and all of eyecare, maybe all of medicine to manage because there's only one thing you can do and, and you can't go wrong. You know, once you diagnose glaucoma, you drop the eye pressure, that's it, do whatever you want to do it. And it's pretty simple in that sense.
Speaker 0 00:04:35 So you talked about, um, using steroids, especially to kind of, uh, the IM implementation process where you're too trying to kind of knock down that big inflammatory beast. Um, but there's a lot of play now where we're talking a lot about dry eye flares. What do you think those are? How do they, how do they impact our current dry patients and how can you find them?
Speaker 2 00:04:58 Yeah. You know, it's interesting that we and I care have really thought of ourselves as kind excluded from general medicine for so many years, thinking of the eye as this really unique system. And I think that holds true for intraocular issues, but external ocular issues as, as well as ocular Nexia, we really are not spared from the rest of the body. We are having to have a lot better understanding of the general eye general meta and that's, that's where unfortunately we're getting brought right back into the basics of general medicine. All inflammation goes through cyclical flares, and you know, it, your really your ability to control homeostasis can dictates your, your disease state level. And so the concept after that, you know, historically dry eye was just an eye disease is really not holding true anymore. And we really have to understand that it is an inflammatory condition.
Speaker 2 00:05:53 That's way more complicated than we initially thought, you know, your blood supply, your glands, they're all controlled by your body, not your eye. And so the concept of understanding that number one, just like the rest of the body, I tell every patient, they need to think of really a dry eye, like arthritis is a chronic inflammatory condition. You're gonna have it forever. Your ability to control it over time is, is, is really heavily dictated by your general health and your inability to control it is gonna require treatments. And that's, that's a flare. And, you know, Walt, it's interesting. I remember sitting with you at a, at a summit meeting years ago and discussing this concept. And, and everyone was arguing that if someone was sitting in front of an air conditioner in their car and they felt really bad, dry eyes, is that a dry eye patient?
Speaker 2 00:06:43 And I would say the majority of the crowd at the time said, no, that's, that's not a dry eye patient. And our understanding now is completely flipped. Cuz if you're not able to maintain a challenge to the, to your ocular, Nexia like air conditioning or like air, like, like anything like that, that's an inability to regulate your homeostasis. That by nature is the beginnings of the disease state. So, uh, you know, just changing the whole concept and our understanding has really led to us understanding that the rest of the body is really gives, gives us endless amounts of data, endless amounts of research in our endless amounts of understandings of how chronic inflammation works. The eye is just really no different.
Speaker 3 00:07:24 So are there any specific questions you ask for your patients? Uh, whenever you're talking about dry eye, dry eye flares, what's that conversation like
Speaker 2 00:07:32 It it's awareness. People should not feel their eye eyes. They shouldn't know they're in their head and if they do, or if they're aware of them at any point, there's something going on there that's not normal. And so we wanna reestablish or, you know, return the system to normal. I'll tell everyone of my patients, my job is to number one, make you feel better in the clinic. And then number two is to reduce the burden of this disease on your life. And, and that often means lessening to drops. I don't want people using artificial tears 10 times a day. It's very unnatural. It actually wipes washes away. Good lipids. So, you know, when it comes to a patient that that's, that you're in my chair for dry eye, I let them know. Number one, I, I wanna make 'em feel better, but then number two, I wanna reduce the amount of drugs and drops that they're using. I, I don't want them using 'em all the time forever. That's that's not what I want.
Speaker 3 00:08:19 So now that we have an FDA approved steroid, does that make a difference?
Speaker 2 00:08:24 Well, you know, in Texas we love steroids ask any of our pro athletes. You know, as a matter of fact, we got a guy here in Austin that won that tour, de France with one testicle. That's how good our steroids are, but when it comes to the concept of FDA approvals, it really it's important to understand that it is a level playing field to judge all products by. So, you know, there are robust studies that, that are well controlled and, and very meticulously SCT throughout the entire process, so, or scrutinized. So I do like the concept of looking at initial FDA studies. Cause I, I feel like most of the time I can trust the data, but you know, one of the things while you are obviously aware of is that you remember an FDA study is only valid for whatever the company submits to the FDA.
Speaker 2 00:09:10 So the company will often prove its product for what's easiest to get to market. And, and that's been a barrier for steroids and dry eye. It's been very difficult to prove that steroids could work in a short term environment for dry, primarily cuz of safety standards historically, that we thought. So, although we've all used steroids for dry a lot, I think it is a pretty monumental step that I, so this did get an approval for dry eye because several before them had tried and not been able to either because of safety profile issues or simply because of they weren't able to show in, in a short clinical study. So it's nice to have a product now that has a robust, you know, well done study that has held up to the FDA scrutiny that, that we can relate to or rely to with patients because again, steroids are steroids and, and one of the biggest, you know, I would say people that we have in the market that are concerned about it are the pharmacists who are dispensing the steroids.
Speaker 2 00:10:06 You, I can't tell you how many times people come back and say, I can't use this for more than 10 days because the pharmacist said I can't because it's in the package label. And I'm like, dude, you got like raging uveitis. You're gonna go blind in 10 days. You know, don't listen to your pharmacist. They're not your doctor. So it it's something that we deal with a lot. But, uh, you know, from there, yeah, as a physician, we all do whatever we want whenever we want, based on the, the data that's out there. And that, that's why it's super important too. And I let my students know all the time, you know, FDA studies are where you start with a product, it gives you a basis and understanding, but you really gotta look to, you know, peer reviewed literature. And the latest studies to that, you know, really will show you what you can do with these products and how you can use 'em in really a wide array. We use so many products that primarily, that have never had an FDA indication for what we're using for.
Speaker 0 00:10:55 Can you share with us, I, I wanna know. I wanna, I know how you prescribe, do you have a typical daily dosage? How do you handle refills? And when do you tend to follow your patients back when you do use a steroid for a dry eye?
Speaker 2 00:11:08 I think the biggest thing to understand what steroids is that the, the biggest risk that we have is, is really pressurize and pressurizes, typically our duration and not dosage dependent. So you want to treat the inflammation aggressively and get up quick, if you are worried about a steroid response. And if people typically don't have a steroid response after the first several weeks, they're likely not going to be a steroid responder. And that allows us to understand how we can use steroids going, going long term. Historically the way that most steroids were used were very surgically or, or be honest with you for dry eye. In, in those situations we would use 'em pretty aggressively, but we wouldn't give refills because there was just, there was a risk of overuse long term with some of the newer steroids being very low dose and FDA approved for dry eye. We're finding that, you know, as long as we're, we can establish, they're not an initial steroid responder with a, with an initial pressure check that it is something that is safe to be used, um, kind of at a PRN nature and for the flare ups. And I will give a refill bottle on almost every dosage of our FDA approved steroids for dry, um, judging that the patient has a solid understanding of how to use them.
Speaker 3 00:12:22 Hey, Derek, you know, we live in this, uh, insurance world. And so I'd like to hear, you know, how, you know, there's some for me, like for instance, I'll go FDA approved. If it's a younger patient, that's, uh, a more commercial insurance. If it's more Medicare, then I'll go with an off-label steroid. Do you do anything different or does that guide your decision? Living in a insurance world,
Speaker 2 00:12:45 Pharmaceutical companies are allowed to rebate or coupon, uh, patients who have insurance, uh, as long as they're not Medicare age or above now, Medicare age or above, you're not allowed to do that because remember, if you have Medicare, the government wants you to die. So they're not gonna give you any coupons or rebates on anything. So it's a tax basically that helps fund the system. And when we do, when we see this, we have to understand that those Medicare age patients are not gonna be eligible for a lot of the rebates that your reps may taught to you about. And we do have a different prescribing. So yeah, I end up using a different steroid for cataract age patients than, than our patients that are not cataract to age because they're knowledgeable for coupons. And some companies were able to get relatively good discounts for Medicare age patients, primarily through specialty pharmacies.
Speaker 2 00:13:35 A and that's another thing if talking real world, and it's just between us girls, you, you gotta understand that most of these coupons are not gonna work at HEB or I'm sorry at, uh, CVS or Walgreens. Because when that patient walks up there with a coupon, there's a hundred people in line waiting to get their Viagra and Lipitor, and that pharmacist could care less about this little specialty coupon you, you have. And so they're really not gonna run it. They're not gonna have time to run it. And it, it's not a bad thing on them. It's just, they're so overwhelmed with what they got going on. And that's where we've had to really rely on specialty pharmacies, any product that's, I'd say within three years of launch, we, we, as a general rule, did not let any of them go to the patient's regular pharmacy. We require them or our tax requiring them to go through specialty pharmacies because they tell 'em number one, it's gonna get cheaper. It's gonna be cheaper. And number two, they still are gonna work with their insurance and it's their best value. And now that they're all sending 'em straight to the patient's house, there's really, there's no reason to sit there and argue with the patient. We just let them know it has to go through a specialty pharmacy.
Speaker 3 00:14:37 Yeah. Well, just like you said earlier,
Speaker 0 00:14:39 Do you, do you special, do you use specialty pharmacies, Walt?
Speaker 3 00:14:43 Uh, we use specialty pharmacies for the same reason that Derek Gretchen,
Speaker 0 00:14:46 I think that's a great tip. And I think that talking to the reps is a great way to get started with how to get in touch with those two. So don't forget to talk to your reps and communicate,
Speaker 3 00:14:57 Hey Derek, one of the things you mentioned earlier was in regards to FDA, uh, uh, the FDA approved steroids, you know, one thing we always look at is efficacy and safety, and we know that there's great, great safety profile, but one of the things we're looking at in seeing with a lot of the newer dry eye is the delivery system. Can you talk about that?
Speaker 2 00:15:16 Yeah. You know, if, if you want to really look at where the innovation's been in the last 25 years in pharmaceutical development, it's really not been new drugs, brought to class or new chemical MOS. It's really been better ways to deliver them. And, and that's really where a lot of the pharmaceutical money and research goes. We have these products that work very well. The problem is getting 'em to the target tissues. And the cornea especially is problematic in general research cause of the biphasic nature. It's really hard to get a drug through multiple layers that are lipic lip phobic, hydrophilic, and hydrophobic, and believe it or not, if you look at really why some of these drugs work dramatically better than others is it's not the molecule itself. It's everything else that goes into it. The pH the, the binding ingredients, the pro drug factors, the nanoparticles that are being developed to, to drive them into the tissue.
Speaker 2 00:16:12 That is really what allows these drugs to work generics don't ever actually have to show. They even work on the eye period, uh, up to the FDA, especially when it comes to eye solutions. They just have to have the same amount of active ingredient, which in many ways tells you nothing. It tells you absolutely nothing. So these new formulations, these, especially these micronized formulations, like Walt had mentioned, they're able to make the molecules much smaller, and that allows them to get through the mucus typically and, and pen, or basically act as a Depot in your sub mucosal, laser, or in your conjunctiva. And by doing that, you basically increase the bio availability and absorption dramatically because the tear washout is such a powerful factor when it comes to topical drugs, that very often you can use drugs. And if you tear significantly or you don't disperse and, and Depot into the tissue within minutes, you can wash all the drug out with having little to no bio availability. And that's the problem with generics in my view.
Speaker 0 00:17:11 So in your view, are steroids enough to effectively treat ocular surface dryness or ocular surface disease, no hap or are you going to have to combine that with something else?
Speaker 2 00:17:23 No, nothing's enough. You gotta remember this is a chronic inflammatory disease with a root pathophysiological problem. Typically based in number one, being a skin disease and number two, a hormonal disease, which supplies a nerve through the eye. So, you know, steroids are nothing more than a bandaid. There are necessary bandaid. There is absolutely no doubt. I will not start any therapy, almost always without a steroid to start with, but that is not doing nothing but reestablishing normal homeostasis and allowing you a chance to fight the battle. The steroids simply gets you in the game. It does, it doesn't fight the fight. And so that's, I think probably the most important thing is understanding that yeah, you can steroid someone and that's great. It, it really is an absolute necessity of first step. The then you gotta figure out the hard part and how you're gonna battle this long term and how you're gonna keep this problem from being an issue down the road.
Speaker 3 00:18:17 Well, perfect. Well, Hey, thank you so much, Derek, for your time and expertise, uh, to help our colleagues understand best practices on prescribing topical steroids for ocular surface disease.
