Revance Therapeutics, Inc. (NASDAQ: RVNC) today announced the publication of results from the Phase 3 studies, SAKURA 1 and SAKURA 2, in Plastic and Reconstructive Surgery (PRS), the peer reviewed Journal of the American Society of Plastic Surgeons. These two Phase 3 studies evaluated Revance’s long-acting neuromodulator product, DaxibotulinumtoxinA for Injection (DAXI), for the treatment of moderate and severe glabellar lines.

This manuscript presents the findings from SAKURA 1 and 2 side-by-side, which demonstrate the consistency of efficacy and safety results evident between the two pivotal studies, as well as the reproducibility of these outcomes with DAXI across patients and clinical trial sites.

Both SAKURA 1 and SAKURA 2 demonstrated that half of the patients treated maintained none or only mild frown lines for at least 24 weeks (approximately 6 months), after a single treatment. Additionally, frown lines did not return to their pre-treatment severity for at least 26–28 weeks for half of the patients treated.

“The publication in PRS highlights the quality of the Phase 3 clinical data and underscores how DAXI unlocks the true potential for a next generation neuromodulator product,” said Mark Foley, President and Chief Executive Officer of Revance Therapeutics, Inc.

SAKURA 1 and SAKURA 2 were identically designed studies, conducted to evaluate consistency of results. Both trials demonstrate that DAXI may offer a prolonged duration of none or mild response (median ≥ 24 weeks) and is generally well tolerated. The most common side effects that developed in response to treatment were headache (5.9%–7.0%), pain at the injection site (2.4%–5.0%) and drooping of the eyelid (eyelid ptosis; 2.0%–2.5%).

“The SAKURA program is the largest ever botulinum toxin type A clinical trial program in subjects with moderate or severe glabellar lines. These data demonstrated a clinically meaningful benefit with a median duration of more than 24 weeks,” said lead author Jean D. Carruthers, MD, who has served as an investigator for multiple FDA-approved neuromodulators and is a clinical professor at the University of British Columbia. “The prolonged duration of clinical benefit with DAXI can help sustain efficacy between treatments and lessen the frequency of re-treatment, which could significantly improve patient satisfaction. DAXI may very well change patients’ expectations for a neuromodulator treatment.”

Additional results from the Phase 3 studies, SAKURA 1, 2, and 3, were presented last week at the American Society for Dermatologic Surgery 2019 (ASDS) Annual Meeting in Chicago. The full publication can be accessed via Revance’s website under the Our Science section or at https://www.revance.com/clinical-information/?category=aesthetics.