Evolus, Inc. announces results from the Phase 2 clinical study evaluating the “extra-strength” 40U dose for extended duration of Jeuveau (prabotulinumtoxinA-xvfs), a neurotoxin dedicated exclusively to aesthetics. Final data were presented at the recent 2023 American Society for Dermatologic Surgery (ASDS) Annual Meeting in Chicago, and demonstrated 26 weeks, or 6 months of duration with the extra-strength dose of 40U across multiple measurements.
“The final Phase 2 outcomes were consistent with interim findings and reinforce that longer-lasting effects—particularly up to 26 weeks—can be achieved with the ‘extra-strength’ 40U formulation of Jeuveau,” says one of the investigators, John Joseph, MD, a facial plastic surgeon. “It is also encouraging to see that both Jeuveau arms demonstrated a favorable and comparable safety profile.”
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 six 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 were similar in all three groups, with 88.9% of them being mild, and no serious adverse events occurred.
“We are pleased to report the results of the completed Phase 2 trial, which provides important insights about the role of this formulation in achieving longer-lasting results,” says Rui Avelar, MD, chief medical officer and head of research and development at Evolus. “This data contributes to the body of knowledge regarding the role of increasing dose and the impact on extended duration and will be of interest to health care providers and patients.”