Two phase 3 studies on daxibotulinumtoxinA for Injection (RT002, Revance Therapeutics) suggest the neuromodulator lessens moderate-to-severe glabellar lines and may last considerably longer than today’s approved options, according to study results released December 5 by Revance.
"RT002 is highly differentiated in terms of duration of effect, and this fulfills my patients’ desires for a longer-lasting neuromodulator. These data show patients may only need treatment with RT002 twice a year, compared with every three or four months for currently available neuromodulators,” study investigator Richard Glogau, M.D., clinical professor of dermatology, University of California, San Francisco, tells The Aesthetic Channel in an email. “For physicians, this means that for the first time we will be able to synchronize facial injectable treatments in a single visit using both neuromodulators and dermal fillers, which are also dosed twice a year. So, doctors can be more effective in coordinating care, and it will be easier for patients to adhere to treatment and maintain the look they desire."
These are results from the SAKURA 1 and SAKURA 2 trials:
About 74% of patients achieved a score of zero or one, meaning none or mild, and at least a two-point improvement from baseline, at maximum contraction in glabellar line severity on the Investigator Global Assessment-Facial Wrinkle Severity and Patient Facial Wrinkle Severity scales at week four. That’s compared to 0 and 1% in each study for the placebo group.
A total of 88% and 91% (in SAKURA 1 and 2, respectively) of patients treated with RT002 were very satisfied or satisfied with the experience at one month.
More than 35% of patients in the RT002 arm versus 2% in the placebo group achieved a “none” or mild response on the Investigator Global Assessment-Facial Wrinkle Severity scale at week 24 in SAKURA 1. Nearly 30% receiving RT002 achieved that outcome at week 24, versus 2% of placebo, in SAKURA 2.
The median time for patients to return to baseline wrinkle severity was 27.7 weeks in SAKURA 1 and 26 weeks in SAKURA 2.
Researchers reported no serious treatment-related adverse events. The most common adverse events in the combined studies were headache, which occurred in 6.4% of patients, and injection site pain, at 3.7%. Eyelid and brow ptosis occurred in 2.2% in SAKURA 1 and 0.7% of subjects in SAKURA 2.
Participants in both trials had moderate-to-severe glabellar lines and were between ages 18 to 75 years.
A third SAKURA to evaluate long-term safety of RT002 has enrolled more than 2,500 patients and should be completed in the second half of 2018, according to the company. Revance plans to submit a Biologics License Application to the FDA in the first half of 2019, and pending FDA approval, launch RT002 in the U.S. in 2020.
The investigational daxibotulinumtoxinA product also is being studied to treat cervical dystonia and plantar fasciitis.
Disclosure: Revance funded the studies in this story. Dr. Glogau was one of the principal investigators for Revance on the SAKURA trials, and previously has been an investigator and paid consultant for Revance.