Extra-strength 40U formulation of prabotulinumtoxinA-xvfs (Jeuveau, Evolus) performed well in a Phase 2 trial for the treatment of moderate to severe glabellar lines in adults.
The 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.
Efficacy results demonstrated 6 months duration across the multiple metrics presented, including the time it took for patients to return to their baseline Glabellar Line Scale (GLS) score after 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 safety profile was similar across all three arms and overall, 88.9% of adverse events were rated as mild and no serious adverse events were identified.
“The study confirms the correlation between increasing dose and increasing duration, while maintaining a similar safety profile, with the majority of adverse events rated as mild,”says Rui Avelar, MD, Chief Medical Officer and Head of R&D of Evolus, in a news release. “
The study appears in the Aesthetic Surgery Journal.
