- Post-hoc analysis demonstrates sustained improvement of static
glabellar lines with repeated treatment of DaxibotulinumtoxinA for
Injection
- Results suggest that the extended duration of therapeutic
benefit with DaxibotulinumtoxinA for Injection can produce dermal
remodeling due to the prolonged period of muscle inactivity
Revance Therapeutics, Inc. (Nasdaq: RVNC) a biotechnology
company focused on innovative aesthetic and therapeutic offerings,
today announced the publication of results from an evaluation of
the progressive effects on static or resting glabellar lines with
the repeated treatment of DaxibotulinumtoxinA for Injection in
Dermatologic Surgery, the official journal of the American Society
for Dermatologic Surgery (ASDS). The peer-reviewed publication
reported efficacy data from a post-hoc analysis of the SAKURA Phase
3 clinical program that demonstrated significant, progressive
improvement in static glabellar lines with repeated treatment of
DaxibotulinumtoxinA for Injection.
“The data published in Dermatologic Surgery showed a substantial
reduction in static glabellar lines and, despite subjects being
required to return to baseline dynamic line severity between
treatments, the improvement in static lines in subjects increased
with repeated treatments,” said Conor Gallagher, Vice President of
Medical Affairs at Revance. “The results seem to indicate that the
extended duration of reduction in dynamic glabellar lines following
treatment with DaxibotulinumtoxinA for Injection allows greater
time for remodeling of static, etched-in lines due to the prolonged
period of muscle inactivity.”
The post-hoc analysis included 568 subjects with moderate or
severe dynamic glabellar lines who were treated with three cycles
of 40U of DaxibotulinumtoxinA for Injection in the SAKURA clinical
program. Glabellar line severity at rest and at maximum frown was
assessed by investigators using the Investigator Global
Assessment-Frown Winkle Severity (IGA-FWS) scale and by subjects
using the Patient Frown Wrinkle Severity (PFWS) scale. Subjects
were required to return to baseline dynamic line severity before
each retreatment.
The results showed rapid and sustained improvement in static
glabellar line severity following repeated treatment with
DaxibotulinumtoxinA for Injection. Improvements in static glabellar
lines were achieved within 2 to 4 weeks following the first
DaxibotulinumtoxinA for Injection treatment cycle and remained
greater than baseline over 24 weeks of follow-up after treatment
cycles 1 and 2. Further, amongst all subjects the proportion with
no static glabellar lines had increased to more than 70% at 4 weeks
after their third treatment cycle of DaxibotulinumtoxinA for
Injection.
Additional results included:
- In those subjects with at least mild static lines at baseline,
complete elimination of those lines was achieved in 54.4% subjects
4 weeks after the first treatment with DaxibotulinumtoxinA for
Injection and further increased to 66.5% and 69.7% 4 weeks after
treatment cycle 2 and 3 respectively.
- An incremental improvement in mean resting line severity was
observed with each treatment cycle with DaxibotulinumtoxinA for
injection, despite a requirement that subjects return to baseline
dynamic line severity between treatment cycles.
The SAKURA Phase 3 clinical program is the largest ever Phase 3
clinical program conducted for glabellar lines and included two
pivotal trials - SAKURA 1 and SAKURA 2 - and an open-label study,
SAKURA 3. The SAKURA clinical program demonstrated that
DaxibotulinumtoxinA for Injection was safe, generally well
tolerated and achieved clinically significant improvement in
glabellar lines with long-lasting results and high patient
satisfaction. In patients treated with DaxibotulinumtoxinA for
Injection, the median time to return to moderate or severe dynamic
glabellar line severity was 24 weeks. The most common treatment-
related AEs were headache, injection site pain and injection site
erythema. The most common treatment-related adverse events were
headache (in 6% of the subjects) followed by eyelid ptosis (2%) and
facial paresis (1%).
Revance has evaluated this neuromodulator formulation in other
phase 2 clinical studies in aesthetics including the full upper
face, forehead lines and crow’s feet as well as in therapeutic
indications, including cervical dystonia and upper limb
spasticity.
About Revance
Revance is a biotechnology company focused on innovative
aesthetic and therapeutic offerings, including its next-generation
neuromodulator product, DaxibotulinumtoxinA for Injection.
DaxibotulinumtoxinA for Injection combines a proprietary
stabilizing peptide excipient with a highly purified botulinum
toxin that does not contain human or animal-based components.
Revance has successfully completed a Phase 3 program for
DaxibotulinumtoxinA for Injection in glabellar (frown) lines and is
pursuing U.S. regulatory approval. Revance is also evaluating
DaxibotulinumtoxinA for Injection in the full upper face, including
glabellar lines, forehead lines and crow's feet, as well as in two
therapeutic indications - cervical dystonia and adult upper limb
spasticity. To accompany DaxibotulinumtoxinA for Injection, Revance
owns a unique portfolio of premium products and services for U.S.
aesthetics practices, including the exclusive U.S. distribution
rights to the RHA® Collection of dermal fillers, the first and only
range of FDA-approved fillers for correction of dynamic facial
wrinkles and folds, and the HintMD fintech platform, which includes
integrated smart payment, subscription and loyalty digital
services. Revance has also partnered with Viatris (formerly Mylan
N.V.) to develop a biosimilar to BOTOX®, which would compete in the
existing short-acting neuromodulator marketplace. Revance is
dedicated to making a difference by transforming patient
experiences. For more information or to join our team visit us at
www.revance.com.
“Revance Therapeutics” and the Revance logo are registered
trademarks of Revance Therapeutics, Inc.
Resilient Hyaluronic Acid® and RHA® are trademarks of TEOXANE
SA.
BOTOX® is a registered trademark of Allergan, Inc.
Forward-Looking Statements
Any statements in this press release that are not statements of
historical fact, including statements about the results of the
post-hoc analysis of the SAKURA Phase 3 clinical program, the
effects on static or resting glabellar lines with the repeated
treatment of DaxibotulinumtoxinA for Injection, our ability to
obtain, and the timing relating to, regulatory approval with
respect to our drug product candidates, including with respect to
DaxibotulinumtoxinA for Injection in glabellar lines and in
therapeutic indications; the rate and degree of commercial
acceptance, opportunity and growth potential of our product
candidates, if approved; the growth opportunities available to the
company; the process and timing of, and ability to complete, the
current and anticipated future clinical development of our product
candidates; the initiation, design, enrollment, submission, timing
and results of our clinical studies, including with respect to the
SAKURA Phase 3 clinical program; statements about our business
strategy, timeline and other goals, plans and prospects, including
our commercialization plans; and potential benefits of our drug
product candidates and our technologies, constitute forward-looking
statements within the meaning of the Private Securities Litigation
Reform Act of 1995, Section 27A of the Securities Act of 1933, as
amended, and Section 21E of the Securities Exchange Act of 1934, as
amended. You should not rely upon forward-looking statements as
predictions of future events. Although we believe that the
expectations reflected in the forward-looking statements are
reasonable, we cannot guarantee that the future results, levels of
activity, performance, events, circumstances or achievements
reflected in the forward-looking statements will ever be achieved
or occur.
Forward-looking statements are subject to risks and
uncertainties that could cause actual results to differ materially
from our expectations. These risks and uncertainties relate, but
are not limited to: the results, timing, costs, and completion of
our research and development activities and regulatory approvals,
including the continuing delay in the FDA’s approval of the BLA for
DaxibotulinumtoxinA for Injection for the treatment of glabellar
lines; the impact of the COVID-19 pandemic on our manufacturing
operations, supply chain, end user demand for our products,
commercialization efforts, business operations, clinical trials and
other aspects of our business; our ability to manufacture supplies
for our product candidates and to acquire supplies of the RHA®
Collection of dermal fillers; the uncertain clinical development
process; the risk that clinical trials may not have an effective
design or generate positive results; the applicability of clinical
study results to actual outcomes; the rate and degree of economic
benefit, the safety, commercial acceptance and the market,
competition, size and growth potential of the RHA® Collection of
dermal fillers, the HintMD fintech platform and our drug product
candidates, if approved; our ability to successfully commercialize
the RHA® Collection of dermal fillers, the HintMD fintech platform
and our drug product candidates, if approved, and the timing and
cost of commercialization activities; our ability to develop sales
and marketing capabilities; the status of commercial
collaborations; our ability to obtain funding for our operations;
our ability to continue obtaining and maintaining intellectual
property protection for our drug product candidates; and our
financial performance, including future revenue, expenses and
capital requirements. Detailed information regarding factors that
may cause actual results to differ materially from the results
expressed or implied by statements in this press release may be
found in our periodic filings with the Securities and Exchange
Commission (SEC), including factors described in the section
entitled "Risks Factors" on our Form 10-K filed with the SEC on
February 25, 2021 and including, without limitation, our Form 10-Q
for the quarter ended June 30, 2021, filed with the SEC on August
5, 2021. The forward-looking statements in this press release speak
only as of the date hereof. We disclaim any obligation to update
these forward-looking statements.
- Glogau S, Kontis TC, et al. Progressive Improvement in Static
Glabellar Lines Following Repeated Treatment with
DaxibotulinumtoxinA for Injection. Derm. Surg. August 16, 2021,
Volume - Issue - doi: 10.1097/DSS.0000000000003211
View source
version on businesswire.com: https://www.businesswire.com/news/home/20210901005187/en/
Media Revance Therapeutics, Inc.: Sara Fahy, 949-887-4476
sfahy@revance.com
Investors Revance Therapeutics, Inc.: Jessica Serra,
626-589-1007 Jessica.serra@revance.com
or
Gilmartin Group, LLC.: Laurence Watts, 619-916-7620
laurence@gilmartinir.com
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