Evolus Announces Publication of Safety and Duration Data from Phase 2 Study for "Extra-Strength" 40U Formulation of Jeuveau®
Business Wire
Wed, Apr 17, 2024, 4:05 PM EDT9 min read
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The article published in Aesthetic Surgery Journal supports safety and duration of effect for temporary improvement in the appearance of moderate to severe glabellar lines presented at the 2023 ASDS Annual Meeting
Data showed duration effect of 26 weeks, or 6 months, based on a ≥ 1-point Glabellar Line Scale (GLS) improvement and return to baseline value using the Global Aesthetic Improvement Scale
NEWPORT BEACH, Calif., April 17, 2024--(BUSINESS WIRE)--Evolus, Inc. (NASDAQ: EOLS), a performance beauty company with a focus on building an aesthetic portfolio of consumer brands, today announced that the Aesthetic Surgery Journal has published the safety and duration of effect results from the Phase 2 study of 40U Jeuveau® (prabotulinumtoxinA-xvfs) for the treatment of moderate to severe glabellar lines in adult patients.
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.
Efficacy 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 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.
"This publication provides the details of the study design along with the efficacy and safety data from the Phase 2 Jeuveau extra-strength study and makes it accessible to all," said Dr. Rui Avelar, MD, Chief Medical Officer and Head of R&D of Evolus. "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."
