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Extra-Strength" Formulation of Jeuveau® Demonstrates Effects Lasting 26 Weeks in Interim Phase II Data Results, Representing Prolonged 6-Month Performance
01/28/2023
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“Extra-strength” 40U formulation achieves one-point improvement on the Glabellar Lines Scale with the duration of effect lasting 26 weeks, representing a prolonged 6-month performance
Results indicate a favorable safety profile; no serious adverse events reported and 88% of all adverse events were mild
Potential new “extra-strength” formulation would expand Evolus' Jeuveau® offering
Trial completion expected mid-2023; final results anticipated to be presented in 2H 2023
NEWPORT BEACH, Calif.--(BUSINESS WIRE)-- Evolus, Inc. (NASDAQ: EOLS), a performance beauty company with a customer-centric approach focused on delivering breakthrough products, today presented interim data from its Phase II clinical study evaluating an "extra-strength" formulation for extended duration of Jeuveau® (prabotulinumtoxinA-xvfs), its flagship neurotoxin product, at the 2023 International Master Course on Aging Science (IMCAS) World Congress in Paris. The data indicated that the “extra-strength” formulation of Jeuveau® at 40U (units) achieved a duration profile of 6 months or 26 weeks.
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. An interim analysis was performed to assess the safety and efficacy of the extra-strength formulation. At this time, Jeuveau® Extra-Strength has demonstrated 6 months (26 weeks) duration 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. 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.
“The interim results of this study are a significant step forward in our strategy to provide a longer-duration treatment option to patients, and we are very pleased that the ‘extra-strength’ formulation of Jeuveau® demonstrated a duration of 6 months or 26 weeks,” said Rui Avelar, M.D., Chief Medical Officer and Head of Research and Development, Evolus. “These data are very encouraging from a safety and efficacy perspective as we are seeing improvement on the GLS scale together with a favorable safety profile.”
“The combination of results from the ‘original strength’ trials and this exciting new ‘extra-strength’ data further reinforces Jeuveau’s® efficacy, offering greater flexibility for clinicians and patients while maintaining a similar safety profile between the two formulations,” said David Moatazedi, President and Chief Executive Officer, Evolus. “‘Extra-strength’ Jeuveau® can be formulated using the same vial used for the ‘original strength’ Jeuveau® simply by modifying the reconstitution. This provides the runway for an exciting option for our customers that already value Jeuveau’s® unique precision profile while delivering natural-looking results.”
Jeuveau® is approved for the temporary improvement in the appearance of moderate to severe vertical lines between the eyebrows seen at maximum frown (glabellar lines) in adults below 65 years of age. The safety and efficacy of Jeuveau® was evaluated through the company’s TRANSPARENCY program, the largest head-to-head pivotal study versus BOTOX® to date. The product is approved for sale in the U.S. under the brand name Jeuveau® and in Canada under the brand name Nuceiva®, which launched in Europe in the second half of 2022, and received regulatory approval in Australia in January 2023.
About “Extra-Strength” Glabellar Line Study
The “Extra-Strength” Glabellar Line Study is a multicenter, double blind, randomized trial that is following 150 patients for up to 12 months at five study sites. The study includes two active controls – the currently approved 20 units of Jeuveau® and 20 units of BOTOX® Cosmetic – which will be compared to 40 units of Jeuveau®. In addition to evaluating the safety, efficacy and duration of effect, this study will also help assess the potential clinical tradeoffs for patients when using the longer duration option.
