AestheticWires’s Toxin Pipeline Watch: RelabotulinumtoxinA Smoothes Crow’s Feet and Frown Lines Quickly and Results Last in Phase IIIb Studies
RelabotulinumtoxinA produces rapid and long-lasting effects on crow’s feet and frown kines, according to topline results from two phase IIIb studies.
Galderma’s relabotulinumtoxinA is a novel liquid formulation of botulinum toxin A currently being investigated globally.
Both trials met their primary endpoints, demonstrating treatment with RelabotulinumtoxinA resulted in a statistically significant improvement in frown lines and crow’s feet, with a rapid onset of action as early as day one and long duration. The results also underscore the durability of RelabotulinumtoxinA with at least a third of patients rating their frown lines as ‘improved’ or better through to month 12 in one study.
Moreover, treatment was well tolerated and all treatment-related adverse events were reported as non-serious, the studies showed.
About the Phase IIIb Studies
43QM2106 is a phase IIIb, randomized, double-blind, placebo-controlled trial to assess the aesthetic improvement and onset of action of RelabotulinumtoxinA in patients with moderate to severe frown lines. The trial met its primary endpoint, with 92.9% of those treated with RelabotulinumtoxinA rating their frown lines as ‘improved’ or better on the Global Aesthetic Improvement Scale (GAIS) at month one, compared to 9.1% of those treated with placebo.
Results reinforced the rapid onset of action and durability of RelabotulinumtoxinA, with 40% of patients rating themselves as ‘improved’ or better on the GAIS as early as day one, and more than a third (38%) of patients rating themselves as ‘improved’ or better at month 12. In addition, 68% and 43% of patients rated themselves as ‘improved’ or better at months six and nine respectively, and 40% of patients also reported at least a one grade improvement of frown line severity at month nine. RelabotulinumtoxinA was well tolerated; the majority of patients did not experience any adverse events and there were no related serious adverse events reported.
43QM2107 is a phase IIIb, open-label, single-center study to assess aesthetic improvement of RelabotulinumtoxinA in patients with moderate to severe crow’s feet and frown lines. It also met its primary endpoint, with 100% of patients treated with RelabotulinumtoxinA rating their crow’s feet and frown lines as ‘improved’ or better on the GAIS at month one.
RelabotulinumtoxinA demonstrated a rapid onset of action for both crow’s feet and frown lines, with the majority of patients (68% and 60% for crow’s feet and frown lines, respectively) rating themselves as ‘improved’ or better on the GAIS starting at day one. By day two, 100% of patients noted improvement for crow’s feet and 96% noted improvement for frown lines. This was reinforced by Subject Live Assessment results using a validated scale, which showed that 40% of patients on day one and 96% of patients on day four received a score of zero or one on a four-point scale for crow’s feet severity at maximum expression. For frown line severity, 32% of patients on day one and 92% of patients on day four received a score of zero or one. RelabotulinumtoxinA was well tolerated, with no adverse events reported in 92% of patients.