Evolus, Inc. announced results from the Phase 2 clinical study evaluating the ?extra-strength? 40U dose for extended duration of Jeuveau® (prabotulinumtoxinA-xvfs), the only neurotoxin dedicated exclusively to aesthetics. Final data were presented at the 2023 American Society for Dermatologic Surgery (ASDS) Annual Meeting on November 3, 2023, in Chicago, and demonstrated 26 weeks, or 6 months of duration with the extra-strength dose of 40U across multiple measurements.

In the Phase 2 study, the ?extra-strength? formulation using 40U of Jeuveau® was compared to active controls, the approved 20U of Jeuveau® and 20U of Botox®, looking at glabellar lines at maximum frown using the validated 4-point Glabellar Line Scale (GLS). Results demonstrated 26 weeks, or 6 months duration across the multiple metrics presented, including the time it took for patients to return to their baseline GLS score after their treatment, the duration of effect for a patient with at least a one-point GLS improvement, and the time it took a patient to return to their baseline using the Global Aesthetic Improvement Scale.

The adverse events profile was similar across all three arms and overall 88.9% of adverse events were rated as mild and there were no serious adverse events. 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. Through the company?s TRANSPARENCY Clinical Program, Jeuveau® was clinically proven to temporarily improve moderate to severe glabellar lines or ?11?s? in adults and included the largest head-to-head pivotal study versus BOTOX®.

The product is approved for sale in the U.S. under the brand name Jeuveau® and in Europe and Canada under the brand name Nuceiva®,and received regulatory approval in Australia in January 2023.