Top-line results from a Phase 2 dose escalation study showed that higher doses of Galderma's Dysport (abobotulinumtoxinA) for Injection offered longer duration of effect with a similar safety profile to the FDA-approved dose of 50U.
The multicenter, randomized, dose-ranging, double-blind, placebo-controlled Phase 2 study enrolled 401 subjects ages 18 to 65 with moderate to severe glabellar lines at maximum frown. Study participants were randomized 4:1 to receive a single dose of Dysport (50U, 75U, 100U or 125U) or placebo and followed for nine months. The primary objective of the study was to evaluate the efficacy of a single dose of Dysport as assessed by the composite responder rate at maximum frown at one month. Secondary objectives evaluated other measures of efficacy as well as duration of treatment response, subject satisfaction, aesthetic improvement and onset of treatment response.
Top-line efficacy results showed that the study met its primary endpoint. After one month, all dose groups treated with Dysport showed a statistically significant composite (investigator and subject-assessed) ≥2-grade improvement when compared with placebo. Favorable results were achieved for all doses in the secondary objectives, including a ≥1-grade improvement and subject satisfaction throughout the study duration. Dysport was well tolerated with a similar safety profile across all doses tested. Treatment-related adverse events were mild or moderate in severity and transient, and no treatment-related serious adverse events were reported.
“We are encouraged that these study results demonstrate that a single dose of Dysport has a rapid onset, long-lasting effect and is well tolerated,” said John H. Joseph, MD, investigator for the study and director of The Clinical Testing Center of Beverly Hills. “At all doses tested in the trial, Dysport had a strong safety profile, including very few cases of eyelid ptosis.”