Long-Term Efficacy and Safety of Liquid Abobotulinumtoxina Formulation for Moderate-To-Severe Glabellar Lines: A Phase III, Double-Blind, Randomized, Placebo-Controlled and Open-Label Study.

BACKGROUND A ready-to-use liquid formulation of abobotulinumtoxinA (aboBoNT-A solution) has been developed. OBJECTIVES To assess long-term efficacy and safety of aboBoNT-A solution for glabellar lines (GL) treatment. METHODS Multicenter, multinational, Phase III study (NCT02493946), with randomized double-blind placebo-controlled (DBPC; 2:1 aboBoNT-A solution 50 U: placebo) and open-label (OL; 4 cycles aboBoNT-A solution) periods; additional patients were recruited into the OL period. Patients were 18-65 years old; BoNT-naive; dissatisfied/very dissatisfied with moderate/severe GLs at maximum frown. Investigator's live assessment (ILA; primary endpoint)/subject's self-assessment (SSA) of GL severity at maximum frown, patient satisfaction with GL appearance, and FACE-Q patient-reported scales (facial appearance overall, psychological well-being, aging) were assessed. Adverse events (AEs) were monitored. Analyses were performed on DBPC and long-term analysis (LTA; all patients receiving ≥ aboBoNT-A solution injection) populations. RESULTS Mean ages of patients were 46.6-47.8 years, and 89.1-91.3% were female, across DBPC (N=190 [n=126 aboBoNT-A solution, n=64 placebo]) and LTA (N=595) populations. Responder rates for ILA, SSA and patient satisfaction were consistent at Day 29 post-injection across repeat LTA cycles (82.2-87.8%, 62.8-80.6% and 72.2-87.8%, respectively), with statistically significantly higher responder rates versus placebo (DBPC cycle; 81.6% versus 0.8%, 68.1% versus 2.3% and 83.1% versus 5.7%, respectively; all p<0.0001). Consistent improvements on FACE-Q scales occurred with repeat cycles (aboBoNT-A solution versus placebo, p<0.0001 [DBPC cycle]). No new or unexpected AEs, or neutralizing antibodies were observed. CONCLUSIONS Results support long-term efficacy and safety of aboBoNT-A solution, and its superiority over placebo, for GL treatment in adults.