Evolus, Inc. presented interim data from its Phase II clinical study evaluating an "extra-strength" formulation for extended duration of Jeuveau® (prabotulinumtoxinA-xvfs), its 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.

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.