Two New Studies Highlight the Efficacy and Safety Profile of Revance's DAXXIFY

Two New Studies Highlight the Efficacy and Safety Profile of Revances DAXXIFY image

DAXXIFY produced an overall positive change in eyebrow position and long-lasting and consistent efficacy across age and race.

Glabellar injection of DAXXIFY show a positive effect on eyebrow position and a high response rate and duration of effect ≥24 weeks across all age and race subgroups, according to two new studies in the Aesthetic Surgery Journal. 

“The newly released publications …showcase Revance’s commitment to generating novel data that helps healthcare providers more fully understand the clinical performance of DAXXIFY,” says Conor Gallagher, PhD, Vice President of Medical Affairs and Scientific Innovation at Revance, in a news release.  “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.”

Dr. Gallagher further states, “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.”

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. Further, a reduction in forehead skin compression (reflective of a reduction in frontalis muscle activity) was observed two weeks post DAXXIFY injection in glabellar lines with the greatest reduction in activity in the lower half of the frontalis.

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. Here 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 of DAXXIFY (40 Units) in SAKURA 1, 2, or 3 and were evaluated for glabellar line severity for ≤36 weeks. Efficacy and safety were analyzed by age (18-45, >45-55, and >55 years) and race (Asian, Black/African American, and White). The proportion of patients achieving none or mild glabellar line severity at maximum frown based on Investigator Global Assessment–Frown Wrinkle Severity (IGA-FWS) rating after DAXXIFY treatment was high in all age and race subgroups (>96% at Week 4). Glabellar line severity of none or mild by composite IGA-FWS and Patient Frown Wrinkle Severity (PFWS) rating was maintained for a median of 24.0 weeks in all age subgroups, and 27.0, 25.3, and 24.0 weeks in the Asian, Black/African American, and White subgroups, respectively. The safety profile of DAXXIFY was consistent across the three main age (18-45, >45-55, and >55 years) and race subgroups, with headache and injection site reactions being the most commonly reported treatment-related treatment emergent adverse events (TEAEs) and treatment-related eyelid ptosis being reported in <2% of patients.

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