Daxxify: The New Longer Lasting Neuromodulator w/ Dr. Michael Kane

Doreen Wu (00:00):

Welcome to Park Avenue Plastic Surgery Class, the podcast where we explore controversies and breaking issues in plastic surgery. I'm your co-host Doreen Wu, a clinical assistant at Bass Plastic Surgery in New York City. I'm excited to be here with Dr. Lawrence Bass, Park Avenue plastic surgeon, educator, and technology innovator. The title of today's episode is Daxxify: The New Longer Lasting Neuromodulator. Dr. Bass, this is a hot topic. I'm looking forward to hearing all about the details.

Dr. Lawrence Bass (00:32):

We've talked about Botox and other neuromodulators on the podcast. Before Daxxify has been a long awaited entry to the marketplace. Botox remains the most popular aesthetic treatment well, one of the improvements most requested by patients is longer durability. Daxxify is a new neuromodulator that has been labeled by FDA for longer duration than Botox. I've asked my close friend and colleague, Dr. Michael Kane to join us for this episode and to share his perspective on this new development. Dr. Kane is a plastic surgeon in New York City and he has spent the past three decades working extensively with Botox and other neuromodulators, with injectable fillers, doing research, lecturing worldwide, and training many, many in advanced techniques using these technologies. He's the author of "The Botox Book," which was published in 2002, and is truly probably the preeminent international authority on this topic. So I'm delighted that he was able to join us and welcome to the podcast.

Dr. Michael Kane (02:00):

It's an absolute pleasure to be here, and thank you so much for that very kind and generous welcome Dr. Bass.

Dr. Lawrence Bass (02:09):

So first we should review the history and the current playing field that Daxxify is entering and trying to disrupt.

Doreen Wu (02:19):

Yes, I always look forward to the history lesson we have. It helps me get a better understanding of where we started and how things are changing now. So Dr. Kane, can you give us a brief overview of how Botox started for aesthetic treatments?

Dr. Michael Kane (02:32):

Sure. Well, Botox, actually its original brand name was Oculinum before they changed the name the Botox. And that was approved back in 1988 for ophthalmologic uses. It was approved for spasm of the muscle around the eye, the muscle that closes the eye, and it was also approved for strabismus, something that lay people often call crosseyedness. There's basically six muscles around each eye within the eye socket that rotate the eye and point it where you wanted to point. And with strabismus, that mechanism was a little off where one muscle was stronger than another or another was weaker and the patient didn't have total control over where their eyes went. And so Botox was developed for human use by an ophthalmologist named Alan Scott, who is really the godfather of all this. He first received what would become Botox at the University of Wisconsin.

(03:40):

And he started to inject it in chimpanzees in the early eighties and then moved on to human beings around the mid eighties. And it was approved for ophthalmologic uses in 88. In 1991, I was chatting with an ophthalmologist, Dr. Richard Lisman in New York, and I was still a fellow at Manhattan Eye, Ear, and Throat. And we're just chatting about what was new in each other's specialties. And Richard says, "have you ever heard about this botulism stuff that you can inject?" And I said, "no." And he said, "well, it relaxes or weakens muscles where you inject it." And I said, "well, how long does it last?" And I thought he was going to say like 24 or 48 or 72 hours. And he said, "oh, about three months." And the next thing I said was, "well, what about the corrugators in the frown area? The forehead, the crow's feet lines?" And I think I waited about 20 seconds and said, "what about the neck cords?" But that's sort of how it started for me.

Doreen Wu (04:49):

And how did the role of Botox develop and broaden over time?

Dr. Michael Kane (04:53):

Well, I first started, I was still in my training my last year of training as a fellow. So I went to my program director. He said, "it's okay, but you know, just to be sure, I want you to talk to the boss," who was then Tom Reese. Talked to Tom Reese for about an hour. He said, "sounds good, but just to be safe, I'm going to retire this year, talk to next year's chairman." You know, everyone wanted to cover themselves. And so I talked to him and he said, "go ahead, but only after you read every word that's been published on this molecule with people," and there was no internet then. So I went to the librarian in the hospital. We used to have medical libraries and every hospital, and she requested these articles. I read them and I started, the first patients I started injecting were people who were going to have what's called a bicoronal brow lift, where they get an incision across the top of their head and we surgically debunk the frowning and forehead muscles and occasionally the crow's feet muscles.

(05:59):

So those patients made sense and they were very happy with the treatment. And then within one year I had injected every muscle in the face. So the four that I talked about are probably the four most commonly injected muscles. But I also thought, well, you know, there's certain muscles in the face that hold things up and certain muscles that pull things down. And I thought that since I really thought that this treatment was going to catch on and become a big deal, I thought, I wonder if you were to relax mostly those muscles that pull things down that maybe I could slow down the aging of people's faces over time. And I think that definitely happens from looking at people, you know, over 30 years that I've been injecting.

Doreen Wu (06:56):

What products joined the playing field after Botox and what kind of impact did they have?

Dr. Michael Kane (07:02):

Well, it's interesting Botox of course was the first for ophthalmologic reasons, and then they had their first cosmetic approval for the frown lines in 2002. And so Botox became sort of a very popular thing to do then. Because once a company has a cosmetic approval, they can promote it for that reason. In other words, when I was doing it cosmetically, they did not have a formal approval. So the company could not promote it for those reasons, although docs could use it for those reasons. The next to come out was Dysport, which came out in '06. And I think that each time a competitor of Botox has come out, it increases public awareness. And I think it grows the market a little bit. I think each time there's a launch just to the fact that people hear about it, more people end up doing it.

(08:06):

And then after Dysport, the next to come along with Xeomin. And there's some scientific differences between all these products. But I would say all of them behave very similarly. They're not identical, but they're not widely disparate. Say like fillers are. With fillers, sometimes they're fillers that are very soft and squishy or say we'd want to use them in the lips. And there're fillers that are very firm and robust that maybe you would use along a jaw line with the the botulinum products. They're awfully similar. And then after Xeomin came, Jeuveau, and then the next one to come along was Daxxify. And you're right. When people are given a survey, and first of all, I just want to say of all the treatments that plastic surgeons do to people, oh, Botox is the most common. And I would say it also has the highest satisfaction, which is interesting. People like it, it works well and they like how it works. However, if you were to ask them in a survey, what would they want? Typically the number one answer is a longer duration. And Daxxify is formulated a little bit differently than the other products. And I believe that it's that formulation that helps it to be a durable, long-lasting botulinum product.

Dr. Lawrence Bass (09:44):

So, you know, the important point, I think exactly as you said, Dr. Kane, is that all of the products leading up to Daxxify, they're all botulinum toxin A they by and large have the same components in different proportions, with the exception of Xeomin, which is only the core molecule. But the performance is similar, the indications are similar. The clinical experience that patients have had in huge numbers, millions a year are similar. But it's a good point that, you know, as new products come, it draws more attention to the field. For a long period of time, Botox was the only product. And so adding new products, even ones that are similar, has a price moderating effect on the marketplace, which is something patients appreciate. It's harder to raise the price if you have competitors than if you are the only player. So I think patients probably have benefited in that way, if nothing else. But we're really at a different point now.

Dr. Michael Kane (11:04):

Yes, I agree completely with that. I'm a huge fan of competition and I think that when it comes to pharmaceuticals, if there are a lot of competitors, I think patients win. That's something that is good for patients. That said, when you try to compare them, sometimes patients will ask you, "well, which one is the best one? Well, you would have to define best. I mean, these products before Daxxify are all very similar that it's sort of like, which is better? Coke or Pepsi? A lot of that is a very personal thing. And I do think that, you know, if someone is good at doing this, if someone is good at reading faces, deciding which muscles to relax and how much I believe that you could use any of these products and make people really happy. And when you look at the products, you know, they have to reveal their data to get FDA approved. And when you look at the data, not only are they very similar and how they work, but they're also very similar as far as patient satisfaction.

Dr. Lawrence Bass (12:17):

And you know, the other thing that's really great about these products is the level of quality control, because the amount of the actual material is teeny and the quality control to get the dosing so perfect treatment after treatment, after treatment is really a triumph of pharmaceutical manufacturing because you have to say the quality control on all of these products is really outstanding. The ones we have in the United States.

Dr. Michael Kane (12:47):

I couldn't agree more. When you talk to people and you get into the Botin science, there's a saying that the process is the product. All of these products are derived from a bacteria to be clear. There's no bacteria that's being injected. It's just the protein that is very purified that the bacteria would make. And so every company has their own process and every company has their own proprietary units. You know, patients sometimes tell you, I get so and so units of this product and so many units of a different product. And those units, you know, there's no international standard of units for botulinum. Those units are proprietary to each company. And so we can't really compare products unit to unit as, as you might think you could.

Doreen Wu (13:45):

So earlier we touched upon this briefly, and Dr. Bass, Dr. Kane, both of you have alluded to it, but Dr. Kane, can you bring us up to speed on this new development? What is Daxxify, what is its history and how is it different from other neuromodulators that are already on the market?

Dr. Michael Kane (14:02):

Well, it's history is interesting. And I guess full disclosure here, I've been working on this project for that company for 17 years. So it's been a long road. But to be fair, I've been working for Allergan, which makes Botox for 25 years. And at one time or another I was a consultant, speaker, or investigator for all of the products. So Daxxify is very different and it's history is different in it's history, sort of reveals how it is different today. Originally this product was designed to be the Botox without needles. So we all know that, you know, there certain, almost everyone would like to look better if, given that yes or no option, but only a certain amount of people do cosmetic plastic surgery every year. And then a certain amount of people are willing to get injections every year.

(15:06):

But when you look at how many people are willing to put a goo of some kind on their skin and look better, well that's almost everybody. And so it was designed to draw botulinum, which is a very big molecule, and that's one of the things about getting products through the skin. Large molecules don't get through the skin very well. Tiny molecules get through the skin more readily. And so there was a peptide in with the botulinum that is different. This peptide is not in any of the other formulations. And this peptide was designed to help pull botulinum through the skin. Now, as you can imagine, that was a very difficult road. And I was an investigator in phase two and we were in phase three, and then that topical program was shelved. And when it was shelved, the company turned towards getting an injectable product to the market.

(16:13):

However, they injected the product with that same peptide that helped to draw it through the skin. And so that was something that makes this product, you know, different than all the other products. And that peptide is an excipient. And just for the audience, all these botulinum products have excipients. And very commonly they're human serum albumin or salt or a little sugar. And the excipients have a role. The excipients have stopped the drug from sticking to the glass file that they're in. They stop the drug from clumping too much together because if, as Dr. Bass was saying, the quality control of these products is astounding. Just for a matter of example, 40 units of Daxxify and 20 units of Botox both contain 0.18 nanograms of the core neurotoxin. So that's an incredibly small amount and it's just bizarre that they lined up like that.

(17:21):

So the quality control is tremendous. And, but then again, if you didn't have these excipients in the vial, a certain percentage of the drug would stick to the vial side. So then how could you be sure how much you were injecting into the patient? So that's why excipients are there. The different excipient, Daxxify was originally there to help pull this big molecule through the skin. But how I think it works, and this is me and I've said this at an academic meeting many years ago. In fact, most large biologic molecules like say botulinum, like insulin, are negatively charged. The where this stuff works is at the end of the nerve terminal. For a muscle to move, it needs a signal. The nerve has to tell the muscle to move. So that's where Botox and its competitors work. They work on that nerve terminal and they stop it from signaling the muscle to work it full strength.

(18:33):

Now the different peptide, excipient in Daxxify is mostly positively charged. So we all know negatives attract, it's sort of like magnets when you're a little kid or you can think of it as Velcro. So since the peptide is positively charged, the botulinum tends to stick to it, which is negatively charged. That terminal nerve membrane is also slightly negatively charged. So if I think that maybe it's that peptide excipient that sort of helps the botulinum working part stick to the cell membrane, which is its target. So I think more of it stays where you want it to be rather than perhaps drifting around. And that's the different in the formulation between Daxxify and the other products.

Dr. Lawrence Bass (19:31):

So as I mentioned earlier, the FDA labeling shows a longer duration. Can you tell us some of the specifics of what the study data shows about duration with Daxxify?

Dr. Michael Kane (19:45):

Absolutely. So since this was a long road to get here, Daxxify has been studied extensively in their clinical trials. The numbers of patients approach 4,000, which is a very large number. And when you look at them, there's a way to assess how long a drug lasts. And I'm not going to get into a lecture on biostatistics, I don't think the audience would find that very exciting, right? But you can do something and create what are called Kaplan-Meier curves. And what that does, it looks at the time point when about half of the patients still have a noticeable effect of the product, and half of them have lost it. And that time point for Daxxify is right about six months. And for the products it's closer to about four, three and a half or four months. And it's interesting, I'm always careful what I say, and sometimes for years that people call things longer or better.

(21:02):

And you know, at least in the certified medical education world, if you're going to make a comparative statement, a direct comparative statement like that, you've gotta have true data. And so this goes a a little bit back to the history of Daxxify as it was being taken along that long pathway to approval in the FDA process are three phases. Phase one, phase two, and phase three and the middle of phase two, in phase two B to be exact, there's always a dose ranging study where you've got a drug and you think it works and the FDA wants to see how it works at different doses. So they did Daxxify at 20 units, 40 units, and 60 units. And at that point, you know, all drug companies are really focused on getting an approval of the drug. And I have to give a shout out.

(21:58):

At that time, the CEO, Dan Browne, did something incredibly bold that I've never seen another company in this space too. When he was doing his dose ranging study for his own drug, he included an arm that had 20 units of Botox in there, or 20 units of onabotulinum, which is the non-brand name, same thing. The data showed that 40 units of Daxxify lasted statistically significantly longer than 20 of Botox. And that label dose of 20 of Botox had been the gold standard in the industry for, you know, over 20 years. So that was a big deal.

Dr. Lawrence Bass (22:50):

Just again, to bring up the points that you raised. So you said there has to be data. So what that means is you can't look at a study of Botox and a different study and a different group of patients of a different product and kind of glue them together. You have to do a study that treats some people with one product and the other in the same study to be able to make that conclusion. So that extra durability again, is, is what everybody hears from their patients, "I love my Botox, but how can I get it to last longer so I don't have to get injected quite as often?" So this looked like this might be the way. The other point I want to make is that 40 Daxxify units is not the same as 40 Botox units. In other words, units for each of the products are unique to that product. And you mentioned the weight of the core molecule, the 0.01, et cetera, et cetera. And nanograms, which is 0.0 1000000000th of a gram, just so people understand. So it's an equivalent weight of the core molecule, but the numbers of the units, it doesn't mean that the Daxxify dose was higher because the units for Daxxify and the units for Botox are different.

Dr. Michael Kane (24:30):

Exactly. And it's sort of strange how we measure drugs, right? For instance, botulinum preparations have been measured in units since they've been on the market. Another drug like that is insulin. So why would you measure a drug in units versus weight? Well, of course, early on, units tend to measure the activity of a drug versus just the weight of a drug. And so obviously with insulin and botulinum, you certainly didn't want too much drug. In other words, you'd be better off putting too little as opposed to too much, although getting it just about right would be ideal. And so they started out being measured in units, but now there are four products on the market. I work with a lot of different companies. I'm currently working with two companies that have two products that are coming soon to the market.

(25:37):

So there are about to be six, and they all have different units. The units are proprietary. Each company has their own way to measure units. And so that makes it confusing. And so, you know, when we give antibiotics to people, there are two ways we could measure it. How do we measure it? We measure it by weight. You give 250 milligrams of amoxicillin or 500 milligrams of ciprofloxin and that's what we're used to. You could certainly plate out bacteria on an agar Petri dish and put some antibiotic on it and see how many bacteria it killed, but that's not what we do. We do everything else by weight. And so when units are so different and they lack a comparison, if you really want to try to compare things, it sort of makes sense to compare them by the weight of the active core, working part, of the botulinum formulation.

Dr. Lawrence Bass (26:47):

So, you know, we talked a little bit about durability with Daxxify in their comparison study, but there's always another side to the story. So what can you tell me about durability with other neuromodulators and where that could be going?

Dr. Michael Kane (27:07):

Sure. Well first let's define some terms. The other neuromodulators have a labeled dose. And let's start with the most simple area, which is the frown lines between the eyebrows. That is typically, and as far as I know, always when one of these products comes to market, that's the indication that they go for, that's sort of the gold standard. So for Botox, it's 20 units. For Dysport, it's 50 Dysport units. For Xeomin, it's 20.

Dr. Michael Kane (00:27:45):

And for Jeuveau, it's 20, and for Daxxify it's 40. So those numbers are different, and that's what the company can promote, teach other docs how to use and advertise. However, in the sort of forever quest to increase longevity, some people, including a friend of ours, John Joseph, started looking at these other botulinum products and saying, "Well, if I injected two or two and a half times as much, could I get them to last longer?" And you can, you can get them to last a little bit longer just by sort of overloading by definition the nerve with more and more botulinum products. So that is another way to push up the duration. But then again, you're putting a lot more drug in the person too. There are pros and cons to everything that you look at.

Dr. Lawrence Bass (00:28:52):

So we see that by re-dosing some of the existing medications, we may move in the direction of the performance that's been shown with Daxxify. You know, the worry with high doses, particularly in that frowner area that you mentioned is eyelid ptosis. Now, I know you have thought process about how eyelids forms and whether that's a problem of injecting too much dose in this area. But how are people trying to avoid more ptosis by going to a higher dose? Or are they seeing more ptosis, yes or no? And what technique are they using to try to avoid that?

Dr. Michael Kane (00:29:52):

So that is a great question because everything that we're just talking about, increasing the dose sounds really good. "Wow, I can take this product I've been using for a long time, just put more in and it's going to last longer." Well, there are a few caveats there. One, I would say the people that have done these studies, like John Joseph and Corey Maas, and there a few others, Martina, are expert injectors. And so they take a relatively large amount of botulinum and inject it, and it better be a really exacting injection. Now, when they have done those studies, they did not notice an increased risk of eyelid ptosis or droopy eyelids. However, you know, like you, I speak at a lot of meetings around the world. And so last summer there's one of these large meetings in London, the FACE meeting, it's held every year and it's usually about 2000 people go to that meeting.

(00:31:03):

And I was on a panel talking about increase in the longevity of botulinum injections. And some of it was about Daxxify, but some of it was also injecting patients at a regular interval. If you can stop that muscle from coming back full strength, their apparent improvement tends to last longer and longer. Also on the panel, there were people talking about what we call high dose injection, what we're just talking about. And so since it was a panel, we asked the room and there were over a thousand injectors of bot in the room. And we said, "how many of you?" And I said, "didn't just do it once or twice, or didn't do it to try it out. And I'm not saying you do it half the time, but how many of you as a routine part of your practice of medicine use a high dose dose to inject these people?"

(00:32:06):

And one or two people raised their hand in a room over a thousand people. So then the next question was, why? Or why did so few people adopt it? And the number one reason was, frankly, what you were just alluding to is that they were afraid. They were afraid of putting this high dose of botulinum in one spot in a patient that it would drift. And they would have, as you mentioned, eyelid ptosis or brow ptosis or getting botulinum in areas they didn't want. That was the number one fear. The second reason was economic, you know, because there are different ways to charge when you're injecting these products. Some people charge per unit, some people charge per area. I've always been a per area person. But if you were charging per unit, you know, how are you going to have that conversation with the patient?

(00:33:10):

"Well, You know, this injection, I'm going to charge you two and a half times as much, and I think it'll last maybe like a month longer than normal." That's not a very good proposition for most patients, I would think. And the audience didn't bring it up. But the third thing I would add is, you know, now after covid and in covid still everyone's sort of up on vaccines. Well, botulinum is a foreign protein. And if you increase the dose and inject people closely together, a small percentage of people start to become immune or non-responders to botulinum. Now, currently that's a very small percentage and the aesthetic or cosmetic world where doses tend to not be very high, however, that number isn't zero. And maybe if you are putting, you know, two and half times protein load in people regularly, you would start to see more non-response again that that longitudinal study has not been done. I'm just sort of pontificating here and extrapolating to one of the issues if it were done.

Dr. Lawrence Bass (00:34:32):

Yeah, those are all important points. Now, one of the ways that I've heard people are trying to avoid spread of effect, unwanted effects far afield of where, where you're targeting with higher doses is by using a very concentrated reconstitution instead of a typical or more dilute reconstitution. And in fact, Daxxiify reconstitutes in a much smaller volume than what the other products do. So is that part of the solution to using other toxins, other neuromodulators in high dose or it's not enough of a difference to protect you from unwanted spread?

Dr. Michael Kane (00:35:34):

No, I think you're hitting the nail on the head there. When you look at the studies of high dose botulinum, they made their concentrations higher. So in other words, they put less saline in so that what they were injecting was more concentrated because they're worried about spread, right? They're worried about clinical spread of this molecule into other muscles that you don't want to hit. You know, one of those things I've said a thousand or 10,000 times from the podium was, "forget about all these recipes and rules, the whole game is how many units do you want to stick where?" And that's it. So what they're doing is concentrating it so they're not getting it stuck to muscles in the area that they don't want to affect. And that's what you would have to do. And one thing I would say, when you look at the label and you look at the reconstitution volumes, yes, at the recommended reconstitution, Daxxify is more concentrated, but if you think that their label dose is 40 units versus 20 for all the other formulations except one, actually the push volumes, if you were to inject the glabella, those volumes are about the same.

(00:37:04):

They're the same. So it's a yes and no. And then it gets into the discussion of spread and diffusion, which are different things. Spread is the motion of the botulinum into areas around the target. Diffusion is just part of spread. Spread has many variables. Diffusion is almost just like the brownie in motion of molecules and by definition goes from higher concentration to lower concentration. So it's interesting when people, and people make mistakes from the podium all the time, and sometimes they'll say, well, "I'm using a higher dose and it's more concentrated to decrease my diffusion." Well, actually that's exactly the opposite. If you have a higher concentration, you're increasing diffusion by definition. But what they're really trying to do is decrease spread.

Dr. Lawrence Bass (00:38:04):

So really there's a lot of complexity here, and it's both technically challenging issue to know if there's another pathway with the older neuromodulators to greater longevity. And there's going to just need to be a practical clinical dimension in figuring out the actual performance of Daxxify. Not in a clinical study with very experienced injectors, but in the clinical marketplace with regular injectors.

Dr. Michael Kane (00:38:45):

I could not agree more. In fact, I've been very involved with the launch of all the other products and part of the launch as you speak to people in the lay press and they would say, "well, what's the difference? How is it different?" And with the other products, there really wasn't very much to say that would get a writer or editor or the people reading the article very excited. But one thing that everyone says they want is something that lasts longer. Now will this shake out in the real world? Well, time will tell, right? Sometimes people say things but they always end up voting with their feet in their wallet as they say. And we have to see how they work. Certainly there's some things where it's obvious, like I have a fair number of people who fly in to be injected by me.

(00:39:51):

Well, if you're flying in from somewhere else and something lasts a little bit longer, well that kind of makes sense. You know, if it's someone right around the corner who actually like, sort of likes coming to the office, well, maybe that's not for them, but maybe it is. And it's not just a duration. Remember what, it's also the convenience. They can avoid an office visit. And when you inject people with botulinum, most people do not get bruised, but the risk of a bruise is never zero. So if you're decreasing the amount of injections over time, you're probably decreasing their risk of a bruise as well. So there are advantages each way.

Dr. Lawrence Bass (00:40:39):

So let me get you to look in the crystal ball and tell me your best sense. Is this going to be a big change in what most patients are using? Or will this just end up being some slice of the neuromodulator market? What do you think is going to happen? How will the introduction of Daxxify disrupt the existing neuromodulator marketplace?

Dr. Michael Kane (00:41:09):

Well, that is always something that's tough to predict, but I do think it will definitely take a slice, but I don't think it will be a small slice. You know, people want duration. That's what they say. And I think that this will appeal to people. Plus we know that, you know, why do people not get it? Well, let's go. Historically, you know, about 20 to 30 years ago, the number one reason for people not getting Botox, that was the only drug around them was that they were afraid that it would do something bad to their health. Well, after decades of millions of people getting it a year, that sort of faded away. And then the next fear, or let's say threshold is a better word, would be, well, you know, I see people on the Oscars and different award shows and they look like statues. They look terrible. And I think now most patients realize that's not the drug's fault, that's the fault of the person on the other end of the needle. Right? And I'm not meaning the patient.

Dr. Lawrence Bass (00:42:24):

Yeah, not bad Botox. Bad injector.

Dr. Michael Kane (00:42:27):

Exactly, exactly. These things are just tools and like any tool, you can use it well or use it poorly. And now, you know, why are some people not getting it? Well, some people think, "well, this idea of having to go in every three or four months doesn't appeal to me." And they seem to think something bad would happen if they didn't keep up with it. And I would say nothing bad happens. There's no rebound negativity from not doing it. But it sort of sounds easier if you can say, well, this stuff really works pretty well for six months. Well, you know, maybe coming in every six or eight months or so that, that may be more appealing and may get more people to do it. It's interesting, I do this thought experiment, and I want to be clear thought experiments are not data, right?

(00:43:26):

We're just talking about data. And so just imagine if things were backwards and you know, whenever there's an established product, it's established for a reason, people like it and it works well, and it works well for them, and there's a little comfort there and they tend to stick with it. But just imagine if instead of being the fourth product out, Daxxify was the first. And so you've got people, and everyone's used to coming back every six or seven or eight months. Not everyone comes back, right? When it starts to wear off, very often, they let it go for a while, and then you had a product that worked for three or four months. And how would you get patients eager to try that? That's different thing, isn't it? That would be a very tough proposition. That said, people like their products that they're on, I'm sure you have patients that are, you know, diehard Dysport patients or Jeuveau or Xeomin patients. And I have many, many, many diehard Botox patients. They love it and sort of wouldn't want to try anything else. So it's a complex issue, what you mentioned, and that's my best answer for it.

Dr. Lawrence Bass (00:44:50):

Yeah, I think I made the point earlier, and I'll say it again, that clinical study performance is not clinical marketplace performance. So we'll have to wait and see in the average injector's hands what kind of performance the product takes, if it matches what the clinical study says, there's at least a compelling reason. You know, this is a different product with different performance according to the FDA label. But separate from that, patients are very attached to their products. And what I usually have said to patients with new neuromodulator introduction before Daxxify was, "listen, if you're getting what you want out of whichever product it is you're using, stick with it. If there's something about what you're getting that's not ideal in your view, then you, because it's a recurrent treatment, maybe next time you try the new product or a different product and see if that works better for you. And if it does, you've got a new favorite product. And if it doesn't, you go back to the product you were using previously." And, you know, a portion of patients, relatively small portion, typically in my practice will tinker. And a lot of them land up back on the original product, but some of them decide they like the new product better. Here again, there's a little more of a compelling reason, but when we get to the takeaways, I'm going to do a thought experiment, which like you said is not data, but I'm going to do a thought experiment about if the product performs this way or it performs this way, not in a population, but for you as an individual, how are you going to feel about switching?

Doreen Wu (00:46:52):

Definitely a lot of factors at play here, and I think only time will tell how this will all play out. So, Dr. Kane, can you give us a teaser as to what else might be coming in the future? What's in the pipeline?

Dr. Michael Kane (00:47:05):

Sure. I think the next two products that will probably, and again with a big caveat, handicapping the FDA and the approval process is a sort of a crystal ball sort of thing. It's hard to do, but I think probably the next two products that would come here would be Letybo, that's the brand name overseas or Letibotulinumtoxin and relabotulinumtoxin. Letybo is a toxin from Hugel, made in Korea, which is sort of the botulinum powerhouse place of the world where many products are manufactured. And relabotulinum, which would be a Galderma product. And it's, you know, commonly called the liquid toxin. So it would be the first formulation that we don't reconstitute in a vial with just a little dust at the bottom, a little solid dust.

(00:48:12):

It already comes as a liquid formulation in the vial. And so those I think are the next two that are going to come. And what will be interesting will, and as Dr. Bass, as you said, I have a bone to pick with people from the podium that compare numbers from one study to a completely different study where there's a different patient population, different injectors, and sometimes different scales are used. That's not good science, but I am curious to see what their duration and their patient satisfaction will be as with everything. And as you just mentioned, how sometimes patients try another product and then they go back to their original, sometimes they stick with another product. Having more and more choices in competition, I think is something that always benefits the patient, which at the end of the day is the number one goal or should be the number one goal of everyone.

Doreen Wu (00:49:21):

And lastly, before we wrap up Dr. Bass, what should our listeners take away from today's episode?

Dr. Lawrence Bass (00:49:26):

So I think we have to look at, first the question, why is neuromodulator the most popular treatment? It hands down is the most frequently performed, in other words, the largest numbers. And as Dr. Kane said, the satisfaction level is sky high compared to any other aesthetic treatment. So there's something about what neuromodulators do, the way it makes us look, that people find extremely pleasing. So that means that we're, you know, given that popularity, we're certain to have more options, more indications, more products. So this is an area that's just going to continue to grow because the performance is so extraordinarily good. In terms of the new product, I said I was going to do a thought experiment and I think how it fares is likely going to result from a price versus duration. And we didn't talk a lot about price of the new product. With Daxxify, if you were getting four months from your Botox and now you get six months or seven months or eight months from Daxxify because a portion of the patients get effects that long and even up to nine months, although that proportion is low there may be a very good value proposition there. But if you're getting, you know, a good four or five months out of your Botox and you get six months out of Daxxify or six and a half months and you paid one and a half times, or you paid twice what you paid for the Botox treatment, you may decide there's not a good value proposition there. And I don't think we know the answer to that because the clinical studies don't look at that pricing factor in patient behavior because nobody in the clinical study is paying for the treatment. So I think we're going to have to wait and see on how that plays out. But there is the convenience factor, and Dr. Kane pointed out, particularly for people who are traveling, people with a busy schedule or people prone to bruising, or people that really just don't like getting poked with needles, that if you get injected less often, you have less trips to the doctor's office and less risk of getting a bruise. So I think we'll see, the public will, as Dr. Kane said, vote with their feet.

Doreen Wu (00:52:08):

Dr. Kane, would you like to add any takeaways?

Dr. Michael Kane (00:52:11):

That sounds exactly perfect. What Dr. Bass said. You know, we can sit here, and again, it's one of the things I say from the podium all the time. I can show you all sorts of graphs and dose response curves and how things work, but at the end of the day, it's difficult to guess in advance how patients will like each product. And you break up patients into two groups of people, how new patients would like each product, each new product, and how patients already using another product that are satisfied with it, how they would treat a new product. And that's a very difficult thing to predict. So what we can do is talk about the science of products, talk about the studies that show tremendous satisfaction with the product, but the final determiners of how these products go are the patients, which is how it should be.

Doreen Wu (00:53:16):

Thank you, Dr. Kane and Dr. Bass for sharing your insight and expertise on this exciting new development in aesthetic medicine.

Dr. Lawrence Bass (00:53:23):

And I'd like to thank Dr. Kane for joining us and really sharing his wealth of expertise over decades working in this particular arena of aesthetic medicine. We were very fortunate to be able to get him to join us and share his perspective. So Dr. Kane, thank you.

Dr. Michael Kane (00:53:44):

Thank you for the invitation. All I can say is that it was an absolute pleasure to be here with both of you today.

Doreen Wu (00:53:53):

Thank you for listening to the Park Avenue Plastic Surgery Class podcast. Follow us on Apple Podcasts, write a review, and share the show with your friends. Be sure to join us next time to avoid missing all the great content that's coming your way. If you want to contact us with comments or questions, we'd love to hear from you, send us an email at podcast@drbass.net or DM us on Instagram @drbassnyc.