Top-line Phase 3 Data Promising for Galderma's RelabotulinumtoxinA

Galderma’s investigational RelabotulinumtoxinA, a novel liquid formulation botulinum toxin A, improves both glabellar and lateral canthal lines with a rapid onset of action and a long duration up to six months, according to top-line phase 3 data presented at the Vegas Cosmetic Surgery & Aesthetic Dermatology meeting (VCS) .

RelabotulinumtoxinA is designed as a liquid, avoiding the traditional requirement to reconstitute from powder, eliminating variability, errors and risks associated with reconstitution, which would be expected to improve the consistency of results. The READY (RElabotulinumtoxin Aesthetic Development StudY) phase 3 clinical program is composed of four phase 3 clinical trials that enrolled more than 1,900 participants. Data presented at VCS came from two of the phase 3 studies.

Both studies met their primary endpoint, demonstrating a significant ≥2-grade composite improvement (as assessed by both subject and investigator) in glabellar line severity and lateral canthal line severity vs. placebo at Month 1, with rapid onset of action and up to six-month duration of action.

In READY-1, participant satisfaction with treatment was high for RelabotulinumtoxinA vs. placebo. At month 1, 97% of participants were satisfied with the outcome of treatment and 86% remained satisfied at Month 6.Treated participants were also highly satisfied with how natural they looked (97% at Month 1, 88% at Month 6).1