PrabotulinumtoxinA is a 900-kDa botulinum toxin Type A produced by Clostridium botulinum.
To investigate the efficacy and safety of prabotulinumtoxinA for the treatment of glabellar lines.
Adult subjects (n = 330 in EV-001; n = 324 in EV-002) with moderate to severe glabellar lines at maximum frown on the 4-point Glabellar Line Scale (GLS; 0 = no lines, 1 = mild, 2 = moderate, and 3 = severe) were enrolled in 1 of 2 identical 150-day, double-blind, placebo-controlled, single-dose, Phase III studies. Subjects were randomized 3:1 to receive 20-U prabotulinumtoxinA or placebo. The primary efficacy end point was the proportion of responders on Day 30 where the investigator and subject independently agreed that a ≥2-point improvement had occurred on the GLS at maximum frown from Day 0. Adverse events (AEs) were evaluated throughout the study.
Responder rates in the prabotulinumtoxinA and placebo groups were 67.5% and 1.2% in EV-001 and 70.4% and 1.3% in EV-002; absolute differences between groups were 66.3% and 69.1% in EV-001 and EV-002, respectively (both p < .001). No serious AE in either study was assessed as study drug related.
In these studies, a single dose of 20-U prabotulinumtoxinA was safe and effective for the treatment of glabellar lines.
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*Department of Clinical Research, Research Institute of the Southeast, West Palm Beach, Florida
†ATS Clinical Research, Santa Monica, California
‡Evolus, Inc., Newport Beach, California
§UCI Health, Orange, California
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A. T. Shamban and K. R. Beer served as principal clinical trial investigators for the EV-001 and EV-002 studies. All participating coinvestigators who formed the EV-001/EV-002 Study Group are listed in the acknowledgments. As sponsor of the EV-001 and EV-002 studies, Evolus, Inc., of Newport Beach, CA, was involved in the design of these studies and provided funding, study materials, equipment, and medications to all investigational sites. Evolus also provided funding to contract organizations involved in data collection, analysis, and reporting of the results. R. L. Avelar is the Head of R&D and Chief Medical Officer for Evolus, Inc., and receives compensation in salary, stock, and stock options. Before and during the time of these studies and manuscript preparation, J. E. Gross was the Chief Scientific Officer at Evolus, Inc.; he will receive royalty and milestone payments should the product be approved. Anneke Jonker of Medical Writing Associates, West Vancouver, BC, Canada, provided technical assistance with manuscript preparation and submission; she holds stock in Evolus, Inc.