Shots:

• Rui gave the details about the “extra-strength” formulation of Jeuveau. He highlighted the study design and results of the trial evaluating  Jeuveau. The data indicated that the “extra-strength” formulation of Jeuveau at 40U achieved a duration profile of 6 months or 26 weeks
• The data was presented at the 2023 IMCAS World Congress in Paris. Rui also talked about how Jeuveau stands out from its competitors in the market focusing on its precise effects
• The interview gives an understanding of how Evolus is evolving its neurotoxin market through its customer-centric approach and innovative digital platform

Smriti: To start with please provide details (ROA, MOA, formulations, etc.) of the "extra-strength" formulation of Jeuveau.

Rui Avelar: The MOA is the same as the original Jeuveau, and the increased duration is a function of the increased dose and concentration of the drug. The “extra-strength” formulation of Jeuveau utilizes the same commercially available vial of the original strength Jeuveau but is reconstituted differently to result in a higher concentration of the product, as well as double the dose.  The product is injected into muscle.

We look forward to the final trial results of the “extra-strength” formulation – which we expect later this year. If results continue to be positive, it will provide an exciting new option for our patients and customers offering extended duration and prolonged performance results.

Smriti: Can we first talk about what exactly is “extra-strength” formulation and what is its significance and how this extra-strength formulation is different functionally from the existing Jeuveau?

Rui Avelar: In the “extra-strength” formulation, two things are altered to increase the duration as compared to the original strength Jeuveau, the dose and the concentration. The dose is doubled, 40U compared to 20U and the formulation is more concentrated. The “extra-strength” formulation uses the same vial used for the original strength Jeuveau but during the reconstitution step, one-quarter of the diluent volume is used. The intent is then to provide the original strength and the Extra-Strength, providing customers and their patients with more options.

We believe having data demonstrating longer duration will be important to addressing customer needs as well as provide an opportunity to extend our product to a wider consumer base.

Smriti: Shed some light on the study design and the results of the P-II clinical trial evaluating the “extra-strength” formulation of Jeuveau?

Rui Avelar: The extra-strength glabellar line study is a multicenter, double-blind, randomized Phase 2 trial following 150 patients for up to 12 months or until the patient loses their correction. The study has three arms: Jeuveau® Extra-Strength 40U and two active controls, Botox® 20U and Jeuveau® 20U.

At the time of presenting interim data at the 2023 International Master Course on Aging Science (IMCAS) World Congress in Paris, the Jeuveau® Extra-Strength 40U arm demonstrated effects lasting 6 months (26 weeks) across the three metrics presented, including the time it takes for patients to return to their baseline Glabellar Line Scale (GLS) score after their treatment, time back to baseline for patients with a response of none or mild on the GLS, and the duration of effect of at least a one-point GLS improvement.  Global Aesthetic Improvement was also assessed to determine the time it took a patient to return back to their baseline appearance. These results paralleled the Glabellar Line Scale findings, with the Jeuveau “Extra-Strength” arm lasting 26.3 weeks compared to 21.6 weeks in 20 units of Jeuveau and 21 weeks in the 20-unit BOTOX arm. The adverse events profile across all three arms was similar. The severity rating demonstrated that 88% of the events were mild and 12% were moderate. Importantly, no serious adverse events were reported.

We anticipate the trial will be completed in mid-2023 and full results to be later this year.  

Smriti: Give our readers a comparative view of how Evolus product Jeuveau stands out from its competitors in the market.

Rui Avelar: Research published in the Journal of Drugs in Dermatology, as well as clinician feedback, report that Jeuveau has a more precise field of effect and that it offers the natural-looking results that patients want and love. Anecdotally we’ve heard about quick-onset of the product, which was reinforced in a study conducted in Europe and Canada, where 54% patients said they had visible results as early as 2 days after treatment.

In 2022, we published a peer-reviewed post hoc analysis in the Aesthetic Surgery Journal which showed with high consistency that men treated with Jeuveau had higher responder rates than those treated with BOTOX. 

When Evolus launched Jeuveau, the market hadn’t seen a new entrant in nearly a decade. As an aesthetics-only, performance beauty company, we are uniquely focused on building a consumer brand for an under-valued but fast-growing consumer demographic – millennials.

By focusing on the millennial mindset, we are evolving the market with the next generation of beauty-oriented patients in mind. These millennial consumers want a quick, in-office beauty treatment with an easy, interactive digital process. Our platform eliminates friction points by streamlining the process for doctors or practices to get access to the product, and the journey consumers need to take to get into the clinic.

Smriti: Apart from the US and Canada, in which geographical locations is Evolus planning to market Jeuveau and the new formulation? Does the company have a marketing strategy for the same?

Rui Avelar: Marketed as Nuceiva outside of the U.S., we launched in Great Britain, the biggest aesthetics market in Europe, late last year and recently announced our launch in Germany and Austria, which is the second largest neurotoxin market in Europe. Jeuveau is approved in all 31 EU countries, and we plan to continue executing a phased expansion into additional European countries over the next couple of years.

Additionally, we received marketing authorization in Australia and are actively building the infrastructure necessary for product launch.

Our marketing strategy will remain the same – to provide performance beauty options for the millennial market. We published a post hoc analysis in Dermatologic Surgery, sharing results from our Phase III studies comparing millennial patients to non-millennials. The data showed Jeuveau was well tolerated in both populations, but highly effective for millennials with moderate-to-severe glabellar lines. Once we complete our Phase 2 study, we plan to work with our advisory board to host a series of discussions to decide next steps.

Smriti: How does interim data presentation at International Master Course on Aging Science (IMCAS) World Congress in Paris 2023 benefit Evolus?

Rui Avelar: Simply put, seeing six months of duration in the interim data is really encouraging because it strongly suggests that customers and patients may be able to obtain the flexibility they desire in the same commercially available vial of Jeuveau, allowing a runway for offering both the original strength and Extra-Strength versions of the product.

Beyond implications for the future of the company’s unique flexibility with this product, presenting at IMCAS provided us with an educational opportunity to contribute to the medical aesthetics community.

We are committed to providing the best options for our patients and customers and believe that expanding research to evaluate how to optimize the product and dosing is an important factor in addressing their needs.

Smriti: Can we hear a little about Evolus, its vision & goal? What does the company mean by performance beauty?

Rui Avelar: Evolus is a performance beauty company, evolving the future of beauty with the science of natural looking results using proprietary Hi-Pure™ technology to drive injection precision.

Our mission is to become a global, multi-product aesthetics company based on our flagship product, Jeuveau, the first and only neurotoxin dedicated exclusively to aesthetics. We are focused on bringing innovation and forward-thinking technology to the beauty industry and aesthetic market by eliminating the barriers existing for customers today, making the beauty experience delightful and achievable.

Smriti: Also share a little about Evolus’ ageing and aesthetic pipeline and also what other areas Evolus is exploring or planning to explore beyond ageing & aesthetics.

Rui Avelar: The aesthetic neurotoxin market is currently underpenetrated and poised for significant growth. And, according to a recent McKinsey study, the younger demographic is twice as likely as the older demographic to adopt injectables, which plays to our strengths as a company uniquely focused on a younger consumer with a brand and digital platform designed to appeal specifically to that audience. 

While Evolus will continue to focus on its flagship product in the immediate future, we are assessing assets that can expand our aesthetic footprint beyond neurotoxins.  If and when other products are added, Evolus’ digital platform will allow the company to evolve and to continue meeting the diverse needs of its customers and patients.

Image Source: Canva 

About the Author: 

Rui Avelar is the CMO and Head of R&D at Evolus. From 2014 to 2018, he also served as the Chief Medical Officer of ALPHAEON. From 2011 to 2013, Rui served as Chief Medical Officer of Allergan Medical, where he was responsible for clinical development, clinical operations, safety, medical writing, biostatistics and regulatory matters. Rui holds a M.D. from the University of Toronto and has received training accreditation in Sports Medicine from the Canadian Academy of Sports Medicine.

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