Insights Into Positive Decision for Galderma's RelabotulinumtoxinA in Europe

Galderma recently announced a positive decision in Europe for relabotulinumtoxinA (Relfydess), a new ready-to-use liquid neuromodulator developed with PEARL Technology.¹ Relfydess is approved for addressing both frown lines and crow’s feet, and is expected to be the first neuromodulator in Europe to receive simultaneous approval for these 2 indications.

The positive decision is supported by data from the READY-1 and READY-2 clinical trials, which highlighted a significant improvement in both frown lines and crow’s feet, with up to 39% of patients experiencing effects from day 1 and 75% maintaining results for 6 months.¹

Dermatology Times recently spoke with Sachin Shridharani, MD, FACS, the lead investigator of READY-1 trial and founder of LUXURGERY, to discuss key takeaways from the READY trials and the potential of Relfydess in the neuromodulator and injectable aesthetic landscapes.

Transcript

Sachin Shridharani, MD, FACS: My name is Sachin Shridharani. I'm a board-certified plastic surgeon based in New York City on Fifth Avenue, and I'm the founder of LUXURGERY, the confluence of luxury and aesthetic surgery. I'm also an associate clinical professor of plastic surgery at Washington University School of Medicine.

Dermatology Times: What were the key findings of the READY-1 and READY-2 clinical trials?

Shridharani: What's really exciting is that the READY studies, or those clinical trials, are basically a group of 4 clinical trials that were run globally and enrolled nearly 2000 subjects. It's a pretty robust and impressive clinical trial program, and it stands for the Relabotulinumtoxin Aesthetic Development Study, so that's where READY comes from. READY-1 and READY-2 are really a function of looking at the indications for both glabellar frown lines, and also kind of the animation, lateral canthal lines. I think what was really exciting, and the key takeaways for me, were basically early onset of action; actually, about 39% in one of the studies, and across all of them, close to about basically a third of subjects who get injected with the relabotulinumtoxin, the Relfydess, start to see a noticeable change by day 1. You're talking about pretty significant early onset of action that's appreciated. Then on the back end, as well, at 6 months, about 75% of subjects who are injected also notice that they continue to maintain a pretty substantial delta from their baseline. They're able to see a change, noticeable change, which is also, again, exciting, because we think about what patients want. We're tapping into the front end of, "I want this to kick in," and we're also tapping it on the back end of being like, "I get longevity." Then, of course, the patient satisfaction was substantial throughout the entire treatment, and all the primary endpoints were met for all 4 studies throughout the entire process.

Dermatology Times: How does the PEARL Technology in Relfydess contribute to its performance and patient outcomes?

Shridharani: PEARL is a proprietary processing and manufacturing technique that is basically part of the Galderma portfolio, specifically for this neuromodulator, and it's about 15 years in the making. It's basically one of those things where this manufacturing process, really what makes the difference to have this liquid toxin. It's a multi step process, and it eliminates a lot of steps, which actually leads to minimizing the decreased potency that we often see with additional processing, and we're also able to then improve the overall efficacy of the neurotoxin. It basically removes the precipitation or precipitants. Freeze drying process has been eliminated, as well. Vacuum drying, and these things can all have, conceptually, some effect on the actual protein and denature occurring on those different molecules. This can all potentially deactivate decreased technology via potency and efficacy. Back to the overall process, it's just this really nice, proprietary distillation process.

Dermatology Times: How does Relfydess compare to the current landscape of neuromodulators?

Shridharani: If you look at comparing it across the board, what's really nice is that again, early onset, as I mentioned earlier, and lengthier duration. We have people who are noticing a significant impact, again, as early as 24 hours. If you start to look at even 2 and 3 days, you get a lion's share of patients that see a nice change quite early on, and then again, have the duration. Some toxins kick it a little bit later, may last a little bit longer. Some don't, some kick in quick. If people feel like at the time they walk out of the clinic, they feel like they're noticing a difference, which is always funny to me. I think that's a nice placebo effect in that sense, for a lot of patients, of just getting injected. But then they also may come back sooner. Here we're really again, looking at the book ends: early onset and longer duration.

Dermatology Times: What is the significance of this positive decision in Europe?

Shridharani: I think the most important thing that comes out it is that toxins in general, now, we have indications for forehead, lateral canthal lines, glabellar lines, looking at masseters, looking at platysma, hyperhidrosis, so many different indications for a neurotoxin. What's nice is, when you have a product that simultaneously has multiple anatomic locations, I have the confidence to be able to treat that patient with the appropriate toxin in the dose. Some toxins usually come out, and they might just have 1 indication, like just the glabellar lines or the lateral canthal lines or the forehead lines. What that means is it's not like I'm going to use a different toxin in a different anatomic area. If I already know that I've got data to support safely using this, I'm not basically practicing or trying to figure out how to treat this other area that hasn't been studied yet, and therefore, we can't guide our clinicians on how many units to treat or what the injection protocol should be. On the surface, it's that first, "Oh, well, great. We're already treating glabellar lines, lateral canthal lines," but here, you actually have the indication, so you have the units, the data, the injection paradigm, so we can go and jump right in as soon as we have product in our practices for commercial use, and we can start to inject patients with that confidence.

Dermatology Times: What are the practical implications for clinicians regarding integration of Relfydess into their practices?

Shridharani: think one of the biggest takeaways, for me, is the ease of use. If we talk about the practicality, firstly, we know early onset, long duration, so we have great confidence there. We can use something that's different. The next thing, of course, is liquid toxin. We're used to taking our filler right off the shelf. Here, we're taking this right out of the refrigerator, so to speak, drawing it up, and injecting. The other thing that I like is that the practicality of it being 150 units per basically 1.5 mLs, means that we have a very easy 10 units per 0.1 mL. When we're drawing product up and treating, we can treat sort of in our 0.05 or 0.1 mL-type increments that we're accustomed to using to be able, for our push volumes, to get a nice overall improvement without it being the sort of weird number of units, which all make a big difference by the end of the day. If you work alone, you've got to keep track of all the patients you're injecting and their dosages. If you're like me, and you have a team of people, and you can be injecting multiple patients and someone recording what you're doing behind you, there's a lot of confusion in these other random increments. Here, we're really looking at a nice, you know, 0.1 mL to basically 10 units.

Dermatology Times: What impact may Relfydess have on the future of neuromodulators and injectable aesthetics?

Shridharani: Firstly, neuromodulator space is becoming somewhat of a crowded space. Depending on what country you're in, what market you're in, you have access from anywhere from 4, 5, 6, 7, 8, and beyond, neurotoxins to choose from. So what become the differentiators? At least for me, this starts to stand out in a crowded space because of the liquid toxin. Convenience is key. Makes life easier. You don't have to be mixing product. But again, taking it back to the experience I've had as a clinical trial investigator, early onset, long duration, that also helps us stand out in a crowded space. We're really tapping into: What is the convenience for the clinician, and what are the patients seeking, and bringing that together as a nice confluence.

Dermatology Times: What else should clinicians know about Relfydess and the recent positive decision?

Shridharani: When I think about what's happening in aesthetics in general, and where the direction is going, increased innovation, whether it's duration or early onset or various now serotypes of different toxins that are going to be available over the course of the next several months to next few years in our practices, it's important to actually have the confidence in scientific rigor. I think these READY studies, firstly, were performed and executed really well. But to even take that further, when you have the confidence in the data, have the confidence in the science, we should be able to translate that into good clinical outcomes for our patients. I think that's where I got excited, because anything that gets FDA approved has enough data and science to have gotten FDA approved. But then what is the actual differentiator versus kind of these, me too, products, which are just an additional one? They erode market share, but they don't actually increase awareness in the market. I think when I look at, where are the changes and differentiators going to occur, and what products do I want to use and support? They're the products that are driving innovation, that are moving the field forward, not just something that looks better on a price point, but something that actually changes the way that we start to practice medicine. I do think that over the course of an entire year or a lifetime, having toxins that are easy to draw up, that just make life convenient and again, tap into what patients are looking for, really just makes a big difference. It's just something that I philosophically, enjoy partnering with folks that are going to help drive innovation.

[This transcript has been edited for clarity.]

Reference

1. Galderma’s Relfydess (RelabotulinumtoxinA) receives positive decision for use in Europe. News release. Galderma. July 30, 2024. Accessed August 9, 2024. https://www.galderma.com/news/galdermas-relfydesstm-relabotulinumtoxina-receives-positive-decision-use-europe