Investigators Joely Kaufman-Janette, MD, et al, established the safety of prabotulinumtoxinA (Jeuveau, Evolus) injections for the treatment of moderate to severe glabellar lines in adult patients in two one-year, multicenter, open-label, repeat-dose, phase II safety studies. The outcomes of the initial study and confirmation study were published in the Aesthetic Surgery Journal (December 2021).
For the first study, 352 adults with moderate to severe glabellar lines at maximum frown received an initial treatment of 20 U prabotulinumtoxinA (4 U/0.1 mL freeze-dried formulation injected into five target glabellar sites), followed by two additional treatments for a total of three treatments in one year.
Fifty-one patients (14.5%) experienced adverse events (AEs) that were considered possibly study drug-related; 11.1% experienced study drug-related AEs after the initial treatment with the rate of AEs decreasing after each repeat treatment.
Six patients (1.7%) experienced study drug-related AEs of special interest: three eyelid ptosis (0.9%), two speech disorder (0.6%) and one blepharospasm (0.3%).
For the second study, 570 subjects received a median total dose of 60 U over the course of three treatments. Sixty-one patients (10.7%) experienced adverse events (AEs) assessed as possibly study drug related; 6.5% experienced study drug-related AEs after the initial treatment.
As with the first study, the rate of AEs decreased with repeat treatment. Eight patients (1.4%) experienced study drug-related AEs of special interest: five eyelid ptosis (0.9%), three eyebrow ptosis (0.5%), one blepharospasm (0.2%) and one blurred vision (0.2%).
The authors concluded that the safety of repeat treatment of 20 U of prabotulinumtoxinA for moderate to severe glabellar lines was established in the first study and confirmed in the second phase II study.