Positive Results from Phase III, Split-Face, Head-to-Head Study Comparing OnabotulinumtoxinA and PrabotulinumtoxinA in the Treatment of Crow’s Feet Lines Published in Dermatologic Surgery
2020-01-27 · Evolus, Inc. · original evolus.com ↗
Primary Endpoint of Non-Inferiority Achieved with Responder Rates* of 65.02% for PrabotulinumtoxinA and 62.56% for OnabotulinumtoxinA at Week 4 NEWPORT BEACH, Calif. , Jan. 27, 2020 (GLOBE NEWSWIRE) -- Evolus , Inc. (NASDAQ: EOLS), a performance beauty company with a customer-centric approach focused on delivering breakthrough products, today announced the publication of results from a Phase 3 study evaluating the safety and effectiveness of prabotulinumtoxinA in crow’s feet lines compared to onabotulinumtoxinA in Dermatologic Surgery . The article titled, “Efficacy and Safety of Prabotulinumtoxin A and Onabotulinumtoxin A for Crow's Feet: A Phase 3, Multicenter, Randomized, Double-Blind, Split-Face Study” is available on the Journal’s Website: https://journals.lww.com/dermatologicsurgery/Abstract/2019/12000/Efficacy_and_Safety_of_Prabotulinumtoxin_A_and.24.aspx . The Phase III multicenter, randomized, double-blind, active-controlled, split-face study was conducted in Korea. The study evaluated the efficacy and safety of prabotulinumtoxinA 1 and onabotulinumtoxinA in the treatment of subjects with bilateral symmetric, moderate to severe crow's feet at maximum smile. A total of 204 subjects were randomized across three medical centers. The primary efficacy outcome was the proportion of subjects with Grade 0 or 1 severity of crow’s feet at maximum smile at Week 4 as assessed by the investigators using a facial wrinkle scale. The primary endpoint of non-inferiority was achieved with responder rates* of 65.02% for prabotulinumtoxinA and 62.56% for onabotulinumtoxinA at Week 4. There were no serious adverse events assessed as drug-related across these studies, and the adverse event rate for the prabotulinumtoxinA and onabotulinumtoxinA arms of the study were similar. Of 204 subjects in the safety analysis set, 22 (10.8%) reported 30 adverse events. All adverse events were mild (11 cases) or moderate (19 cases) in severity. “The results of this head-to-head Phase 3 study comparing prabotulinumtoxinA and onabotulinumtoxinA in the treatment of crow’s feet add important new clinical information to the already robust data set surrounding prabotulinumtoxinA,” said Rui Avelar , MD, Chief Medical Officer and Head of Research & Development at Evolus, Inc. About Evolus, Inc. Evolus is a performance beauty company with a customer-centric approach focused on delivering breakthrough products. In 2019, the U.S. Food and Drug Administration approved Jeuveau ® (prabotulinumtoxinA-xvfs), the first and only neurotoxin dedicated exclusively to aesthetics and manufactured in a state-of-the-art facility using Hi-Pure™ technology. Jeuveau ® is powered by Evolus' unique technology platform and is designed to transform the aesthetic market by eliminating the friction points existing for customers today. Visit us at: www.evolus.com . Jeuveau ® is a registered trademark of Evolus, Inc. Hi-Pure™ is a trademark of Daewoong Pharmaceutical Co, Ltd * Responder rate = the proportion of subjects with a crow's feet severity of Grade 0 or 1 at maximum smile as assessed by the investigators using a facial wrinkle scale at Week 4 (the primary efficacy outcome). 1 The process for producing the formulation of prabotulinumtoxinA used in the study involved freeze-drying. Jeuveau ® (prabotulinumtoxinA-xvfs) is produced using a vacuum-drying process. Evolus , Inc. Contacts: Investor Contact: Ashwin Agarwal, Evolus, Inc. Vice President, Finance, Investor Relations & Treasury Tel: +1-949-284-4559 Email: [email protected] Media Contact: Crystal Muilenburg, Evolus, Inc. Vice President, Corporate Communications & Public Relations Tel: +1-949-284-4506 Email: [email protected] Source: Evolus View All News Contact Us Nareg Sagherian 248.202.9267 [email protected] Quick Links SEC Filings opens in new window Investor FAQs opens in new window Information Request Form opens in new window Investor Email Alerts Personal Information. Email Address * Required Email Address is required. Email Address is invalid. Investor Alert Options * News Quarterly Reports Annual Reports SEC Filings End of Day Stock Quote Events & Presentations Investor Alert Options is required. The captcha test has failed. Please try again. Submit Unsubscribe REQUEST A MEETING WITH MANAGEMENT > © 2026 Evolus, Inc. - All rights reserved Powered By Q4 Inc. 5.187.1.9 (opens in new window) Privacy Policy opens in new window | Terms of Use opens in new window | Site Map opens in new window Gap List Fix
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