Revance announced that two studies showed that Daxxify was an effective and safe treatment for frown lines and improvements to eyebrow position.
Revance Therapeutics announced the publication of two peer-reviewed articles in Aesthetic Surgery Journal that reported how effective Daxxify (DaxibotulinumtoxinA-lanm) was on treating frown lines and eyebrow position.
The publications reported the impact of Daxxify or injection on brow position and frontalis muscle activity from a post-hoc analysis of patients in the Phase 2a forehead line (FHL) study and the Sakura open-label safety (OLS) study.
They also presented the efficacy and safety of Daxxify analyzed by age and race based on a subgroup analysis of the Sakura glabellar lines clinical trials.
“The newly released publications in the Aesthetic Surgery Journal showcase Revance’s commitment to generating novel data that helps healthcare providers more fully understand the clinical performance of Daxxify,” said Conor Gallagher, PhD, vice president of medical affairs and scientific innovation at Revance. “This data demonstrates that treatment of frown lines with Daxxify results in an overall positive change in eyebrow position even with a modest reduction in forehead muscle activity.”
The first publication evaluated the impact of glabellar injection of Daxxify on eyebrow position and frontalis activity. A post hoc analysis of patients from the Phase 2a FHL and Sakura OLS studies, who received a single dose of Daxxify 40 Units to the glabella, showed a positive reduction in dynamic frontalis activity while maintaining or slightly lifting the eyebrows.
Two weeks after treatment with Daxxify in glabellar lines, mild eyebrow elevation (at rest) was observed in the lateral, mid, and medial brow regions. A reduction in forehead skin compression (reflective of a reduction in frontalis muscle activity) was also observed two weeks post injection in glabellar lines with the greatest reduction in activity in the lower half of the frontalis.
“The subgroup analysis displays a consistent duration of effect across adult patients of all ages and skin types, bolstering Revance’s commitment to advancing scientific research in a range of ethnic and diverse backgrounds,” said Gallagher.
A separate publication evaluated the efficacy and safety of Daxxify in the treatment of glabellar lines across age and race based on a subgroup-analysis of patients treated in the Phase 3 Sakura clinical program. Daxxify demonstrated long-lasting efficacy in all subgroups, consistent with the overall population results of the Sakura clinical trials.
The analysis included 2,785 patients with moderate to severe glabellar lines who received their first dose in Sakura 1, 2, or 3 and were evaluated for glabellar line severity for about 36 weeks.
The proportion of patients achieving none or mild glabellar line severity at maximum frown after Daxxify treatment was high (96%) in all age and race subgroups. Glabellar line severity of none or mild by composite IGA-FWS and Patient Frown Wrinkle Severity (PFWS) rating was maintained for a median of 24 weeks in all age subgroups, and 27, 25.3, and 24 weeks in the Asian, Black/African American, and White subgroups, respectively.
The safety profile was consistent across the three main age and race subgroups, with headache and injection site reactions being the most commonly reported treatment-related treatment emergent adverse events and treatment-related eyelid ptosis being reported in around 2% of patients.