PrabotulinumtoxinA-xvfs for the Treatment of Moderate-to-Severe Glabellar Lines.

[OBJECTIVE] PrabotulinumtoxinA-xvfs (Jeuveau), a botulinum toxin type A, was approved by the Food and Drug Administration for the temporary improvement in the appearance of moderate-to-severe glabellar lines in February 2019. This article will review phase II and III clinical trials to assess the efficacy, safety, and clinical application of this novel, aesthetic-only drug.

[DATA SOURCES] A systematic literature review was performed using the terms "glabellar lines AND prabotulinumtoxinA" in the PubMed database. ClinicalTrials.gov was searched to identify nonpublished studies.

[STUDY SELECTION AND DATA EXTRACTION] Articles written in English between November 2019 and June 2020 discussing phase II and phase III clinical trials were evaluated.

[DATA SYNTHESIS] By the primary efficacy end point on day 30, more patients achieved a greater than 2-point improvement on the Glabellar Line Scale (GLS) at maximum frown compared with baseline on day 0. The proportions of participants who responded to treatment with prabotulinumtoxinA were 67.5% and 70.4% versus 1.2% and 1.3% in placebo groups across 2 identical clinical trials ( < 0.001). Patients receiving prabotulinumtoxinA experienced greater improvement in GLS at maximum frown on day 30 (87.2%) compared with onabotulinumtoxinA (82.8%) and placebo (4.2%; < 0.001). PrabotulinumtoxinA was well tolerated across all studies.

[RELEVANCE TO PATIENT CARE AND CLINICAL PRACTICE] This review provides a detailed analysis of the safety and efficacy of prabotulinumtoxinA-xvfs and includes special considerations to help guide patients and clinicians.

[CONCLUSION] PrabotulinumtoxinA is a safe and effective new addition to the repository of available treatments for the appearance of glabellar lines.