- “Extra-strength” 40U formulation demonstrated a duration of 26
weeks, or 6 months, when measuring the time for a patient to return
back to their baseline Glabellar Line score after a single
treatment
- 40U results indicate a similar safety profile to lower dose
arms in the study
Evolus, Inc. (NASDAQ: EOLS), a performance beauty company with a
focus on building an aesthetic portfolio of consumer brands,
announced results from the Phase 2 clinical study evaluating the
“extra-strength” 40U dose for extended duration of Jeuveau®
(prabotulinumtoxinA-xvfs), the only neurotoxin dedicated
exclusively to aesthetics. Final data were presented at the 2023
American Society for Dermatologic Surgery (ASDS) Annual Meeting on
November 3, 2023, in Chicago, and demonstrated 26 weeks, or 6
months of duration with the extra-strength dose of 40U across
multiple measurements.
“The final Phase 2 outcomes were consistent with interim
findings and reinforce that longer-lasting effects – particularly
up to 26 weeks – can be achieved with the ‘extra-strength’ 40U
formulation of Jeuveau®,” said one of the investigators, John
Joseph, M.D., Facial Plastic Surgeon. “It is also encouraging to
see that both Jeuveau® arms demonstrated a favorable and comparable
safety profile.”
In the Phase 2 study, the “extra-strength” formulation using 40U
of Jeuveau® was compared to active controls, the approved 20U of
Jeuveau® and 20U of Botox®, looking at glabellar lines at maximum
frown using the validated 4-point Glabellar Line Scale (GLS).
Results demonstrated 26 weeks, or 6 months duration across the
multiple metrics presented, including the time it took for patients
to return to their baseline GLS score after their treatment, the
duration of effect for a patient with at least a one-point GLS
improvement, and the time it took a patient to return to their
baseline using the Global Aesthetic Improvement Scale. The adverse
events profile was similar across all three arms and overall 88.9%
of adverse events were rated as mild and there were no serious
adverse events.
“We are pleased to report the results of the completed Phase 2
trial, which provides important insights about the role of this
formulation in achieving longer-lasting results,” said Rui Avelar,
M.D., Chief Medical Officer and Head of Research and Development,
Evolus. “This data contributes to the body of knowledge regarding
the role of increasing dose and the impact on extended duration and
will be of interest to health care providers and patients.”
Jeuveau® is approved for the temporary improvement in the
appearance of moderate to severe vertical lines between the
eyebrows seen at maximum frown (glabellar lines) in adults below 65
years of age. Through the company’s TRANSPARENCY Clinical Program,
Jeuveau® was clinically proven to temporarily improve moderate to
severe glabellar lines or “11’s” in adults and included the largest
head-to-head pivotal study versus BOTOX®. The product is approved
for sale in the U.S. under the brand name Jeuveau® and in Europe
and Canada under the brand name Nuceiva®,and received regulatory
approval in Australia in January 2023.
About “Extra-Strength” Glabellar Line Study
The “Extra-Strength” Glabellar Line Study is a multicenter,
double blind, randomized trial that followed 150 patients until
they lost their correction or up to 12 months at five study sites.
The study includes two active controls – the currently approved 20
units of Jeuveau® and 20 units of BOTOX – which were compared to 40
units of Jeuveau® in addition to evaluating the safety, efficacy
and duration of effect.
About Evolus, Inc.
Evolus (Nasdaq: EOLS) is a performance beauty company evolving
the aesthetic neurotoxin market for the next generation of beauty
consumers through its unique, customer-centric business model and
innovative digital platform. Our mission is to become a global,
multi-product aesthetics company based on our flagship product,
Jeuveau® (prabotulinumtoxinA-xvfs), globally licensed under the
brand name Nuceiva®. The product is manufactured in a
state-of-the-art facility using Hi-Pure™ technology. Evolus is
expanding its product portfolio having entered into a definitive
agreement to be the exclusive U.S. distributor of Evolysse™, a line
of five unique dermal fillers currently in late-stage development.
Visit us at www.evolus.com, and follow us on LinkedIn, X, Instagram
or Facebook.
IMPORTANT SAFETY INFORMATION FOR JEUVEAU®
(prabotulinumtoxinA-xvfs)
JEUVEAU may cause serious side effects that can be life
threatening. Get medical help right away if you have any of these
problems any time (hours to weeks) after injection of
JEUVEAU:
- Problems swallowing, speaking, or breathing, due to
weakening of associated muscles, can be severe and result in loss
of life. You are at the highest risk if these problems are
pre-existing before injection. Swallowing problems may last for
several months.
- Spread of toxin effects. The effect of botulinum toxin
may affect areas away from the injection site and cause serious
symptoms including: loss of strength and all-over muscle weakness,
double vision, blurred vision and drooping eyelids, hoarseness or
change or loss of voice, trouble saying words clearly, loss of
bladder control, trouble breathing, trouble swallowing.
Do not use JEUVEAU if you: are allergic to any of the
ingredients in JEUVEAU (see Medication Guide for ingredients); had
an allergic reaction to any other botulinum toxin product such as
rimabotulinumtoxinB (MYOBLOC®), onabotulinumtoxinA (BOTOX®/BOTOX®
Cosmetic), abobotulinumtoxinA (DYSPORT®), or incobotulinumtoxinA
(XEOMIN®); have a skin infection at the planned injection site; or
are a child.
JEUVEAU dosing units are not the same as, or comparable to,
any other botulinum.
Tell your healthcare provider about all your muscle or nerve
conditions, such as ALS or Lou Gehrig’s disease, Myasthenia
gravis, or Lambert-Eaton syndrome, as you may be at increased risk
of serious side effects including difficulty swallowing and
difficulty breathing from typical doses of JEUVEAU.
Tell your healthcare provider about all your medical
conditions, including: any side effects from botulinum toxin
products, including dry eye; breathing, swallowing, bleeding, or
heart problems; plans to have surgery; weakness of forehead
muscles; drooping eyelids; have had surgery on your face; are
pregnant or breastfeeding or plan to become pregnant or breastfeed
(it is not known if JEUVEAU can harm your unborn baby or passes
into breast milk).
Tell your healthcare provider about all the medicines you
take, including prescription and over-the-counter medicines,
vitamins, and herbal supplements. Using JEUVEAU with certain other
medicines may cause serious side effects. Do not start any new
medicines until you have told your healthcare provider that you
have received JEUVEAU in the past.
Especially tell your healthcare provider if you: have
received any other botulinum toxin product in the past and the last
4 months, and exactly which product you received (such as BOTOX,
BOTOX Cosmetic, MYOBLOC, DYSPORT, or XEOMIN).
JEUVEAU may cause loss of strength or general muscle weakness,
vision problems, or dizziness within hours to weeks of treatment
with JEUVEAU. If this happens, do not drive a car, operate
machinery, or do other dangerous activities.
JEUVEAU can cause other serious side effects including:
allergic reactions such as itching, rash, red itchy welts,
wheezing, trouble breathing, asthma symptoms, or dizziness or
feeling faint. Tell your healthcare provider or get
emergency medical help right away if you develop wheezing or
trouble breathing, or if you feel dizzy or faint. Heart
problems. Irregular heartbeat and heart attack that have caused
death, have happened in some people who received botulinum toxin
products. Eye problems such as dry eye, reduced blinking,
and corneal problems. Tell your healthcare provider if you develop
eye pain or irritation, sensitivity to light, or changes in your
vision.
The most common side effects include: headache; eyelid drooping,
upper respiratory tract infection, and increased white blood cell
count.
APPROVED USE
JEUVEAU is a prescription medicine that is injected into muscles
and used in adults for a short period of time (temporary) to
improve the look of moderate to severe frown lines between the
eyebrows (glabellar lines).
The risk information provided here is not complete. For more
information about JEUVEAU, see the full Prescribing Information
including BOXED WARNING, and Medication Guide, visit evolus.com or
talk to your healthcare provider.
To report side effects associated with use of JEUVEAU, please
call 1-877-EVOLUS1/1-877-386-5871. You are encouraged to report
negative side effects of prescription drugs to the FDA. Visit
www.fda.gov/medwatch or call 1-800-FDA-1088.
Exclusively licensed and manufactured for: Evolus, Inc., 520
Newport Center Drive, Suite 1200, Newport Beach, CA 92660
Forward-Looking Statements
This press release contains forward-looking statements as
defined under the Private Securities Litigation Reform Act of 1995
that involve risks and uncertainties, including statements based on
our current expectations, assumptions, estimates and projections
about future events, our business, financial condition, results of
operations and prospects, our industry and the regulatory
environment in which we operate. Any statements contained herein
that are not statements of historical facts may be deemed to be
forward-looking statements. In some cases, you can identify
forward-looking statements by terms such as “anticipate,”
“believe,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,”
“potential,” “predict,” “project,” “should,” “will,” “would” or the
negative of those terms, or other comparable terms intended to
identify statements about the future. The company’s forward-looking
statements include, but are not limited to, statements related to
the company’s expectations regarding the impact of the study
results on future regulatory programs, the commercial success of
Jeuveau® and related research and development activities.
The forward-looking statements included herein are subject to
risks and uncertainties that could cause actual results to differ
materially from those expressed or implied by the forward-looking
statements. These risks and uncertainties, all of which are
difficult or impossible to predict accurately and many of which are
beyond our control, include, but are not limited to uncertainties
associated with our ability to comply with the terms and conditions
in the Allergan/Medytox Settlement Agreements, our ability to fund
our future operations or obtain financing to fund our operations,
the continued impact of COVID-19 or other outbreaks of contagious
diseases on our business, unfavorable global economic conditions
and the impact on consumer discretionary spending, uncertainties
related to customer and consumer adoption of Jeuveau®, the
efficiency and operability of our digital platform, competition and
market dynamics, our ability to successfully launch and
commercialize our products in new markets, our ability to
successfully broaden our product portfolio, our ability to maintain
regulatory approvals of Jeuveau® or obtain regulatory approvals for
new product candidates or indications and other risks described in
our filings with the Securities and Exchange Commission, including
in the section entitled “Risk Factors” in our Quarterly Report on
Form 10-Q for the quarter ended June 30, 2023 filed with the
Securities and Exchange Commission on August 2, 2023. These filings
can be accessed online at www.sec.gov. Readers are cautioned not to
place undue reliance on these forward-looking statements, which
speak only as of the date hereof. Except as required by law, we
undertake no obligation to update or revise any forward-looking
statements to reflect new information, changed circumstances or
unanticipated events. If we do update or revise one or more of
these statements, investors and others should not conclude that we
will make additional updates or corrections.
Jeuveau® and Nuceiva® are registered trademarks of Evolus, Inc.
Evolysse™ is a trademark of Evolus, Inc. Hi-Pure™ is a trademark of
Daewoong Pharmaceutical Co, Ltd. BOTOX® is a registered trademark
of Allergan Inc.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20231105855170/en/
Investor Contact: Idalia Rodriguez,
Ned Mitchell Arbor Advisory Group Email: ir@evolus.com
Media Contact: Email:
media@evolus.com
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