Efficacy and safety of neuronox^® for lateral canthal lines: a phase I/III, multicenter, randomized, double-blind, active-controlled study

Introduction: Neuronox^® has not yet been investigated for its efficacy and safety in the treatment of lateral canthal lines (LCL). Methods: This study was a randomized, double-blind, active drug controlled, multicenter, 16 week, Phase I/III study designed to determine the non-inferiority of Neuronox^® compared to onabotulinumtoxin A (ONA) in the treatment of moderate to severe LCL. Thirty subjects in Phase I and 220 subjects in Phase III were randomized in a 1:1 ratio to receive a single treatment (24 U) of either Neuronox^® or ONA. The primary endpoint of the Phase III study was the responder rate according to the proportion of subjects achieving Grade 0 (none) or 1 (mild) from 2 (moderate) or 3 (severe) in LCL severity at maximum smile as assessed by the investigators at Week 4. Additional efficacy endpoints and safety endpoints (adverse events) were also evaluated. Results: The primary endpoint was achieved as the proportion of responders was 83% for both Neuronox^® and ONA, thus, supporting the non-inferiority of Neuronox^® compare to ONA. The two groups also showed no statistical differences in safety analyses. Conclusion: Treatment of moderate to severe LCL with Neuronox^® was effective and well-tolerated.