Collective results from the SAKURA phase 3 clinical trial program investigating daxibotulinumtoxinA for injection (“DAXI”, Revance Therapeutics) for the treatment of moderate-to-severe glabellar lines show that the neuromodulator provides generally safe and long-lasting benefit with one treatment consisting of five injection points: two in each corrugator muscle and one in the procerus muscle.
SAKURA 3, which was an open-label phase 3 safety study investigating DAXI for treatment of moderate-to-severe glabellar frown lines, enrolled 2691 patients who received up to three repeat treatments at an interval of 36 weeks. Overall, patients received a total of 3830 injections of DAXI 40 U (8 U per point).
“This is the largest clinical trial ever conducted investigating aesthetic treatment with a neuromodulator," says Sabrina Fabi, M.D., who was an investigator. "The effcacy results paralleled those seen in the randomized, placebo-controlled SAKURA 1 and SAKURA 2 clinical trials showing that DAXI was very effective at one month and was associated with prolonged benefit, typically persisting five to six months post-injection,” says Dr. Fabi, associate research director, Cosmetic Laser Dermatology, San Diego.
SAKURA 3 was a prospective, 84-week study. Eligible patients had moderate-to-severe glabellar lines judged using the four-point Investigator Global Assessment-Frown Wrinkle Severity Scale; baseline severity was rated “moderate” in approximately two-thirds of the enrolled cohort. Approximately 12% of patients enrolled in SAKURA 3 had been previously treated with DAXI in SAKURA 1 or 2. A total of 40% of all subjects had been treated previously with another botulinum toxin product.
Patients received DAXI 40 U. Subjects selected for retreatment could receive it no sooner than 12 weeks later and once their frown severity score had returned to baseline. These patients were eligible for a third injection using the same criteria. Follow-up visits were scheduled at weeks 1, 2, 4 and every four weeks through week 36 after the first and second injections and through week 12 following a third injection. A total of 2,380 patients received a first DAXI injection, 882 patients were treated with a second cycle, and 568 patients received a third DAXI injection in SAKURA OLS.
Revance Therapeutics submitted a Biologics License Applications to the FDA for DAXI in the treatment of moderate-to-severe glabellar lines in November 2019.
Dr. Fabi is an investigator for Allergan, Croma, Galderma, Merz, and Revance and has stock in Allergan and Revance.