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
- Category: Proteins and Peptides
- Published on Monday, 27 January 2020 17:33
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Primary Endpoint of Non-Inferiority Achieved with Responder Rates* of 65.02% for PrabotulinumtoxinA and 62.56% for OnabotulinumtoxinA at Week 4
NEWPORT BEACH, CA, USA I January 27, 2020 I 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:
The Phase III multicenter, randomized, double-blind, active-controlled, split-face study was conducted in Korea. The study evaluated the efficacy and safety of prabotulinumtoxinA1 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.