Written by Tonya Johnson
Galderma today announced top-line results from a Phase 2 study on the impact of dose escalation on the duration of effect and the efficacy and safety of a single dose of Dysport (abobotulinumtoxinA) for Injection (50U, 75U, 100U or 125U) versus placebo for the treatment of moderate to severe frown lines between the eyebrows (glabellar lines).
Results showed that the study met its primary endpoint, with significantly more subjects treated with Dysport at all four doses achieving a composite two grade improvement responder rate than those treated with placebo at one month. Data from secondary endpoints demonstrated promising results for a potential prolonged duration of effect correlated with higher doses. Dysport, also marketed as Azzalure in some countries, is a prescription injection for temporary improvement in the look of moderate to severe glabellar lines in adults less than 65 years of age.
“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.”
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, the dose in the FDA-approved label, 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.
“This phase 2 study underscores our commitment to bring efficacious products and long-lasting results to customers,” said Baldo Scassellati Sforzolini, global head of research and development at Galderma. “Based on these encouraging safety and long-term efficacy results, as well as continued patient satisfaction, we are evaluating future clinical studies.”