- The article published in Aesthetic Surgery Journal supports
safety and duration of effect for temporary improvement in the
appearance of moderate to severe glabellar lines presented at the
2023 ASDS Annual Meeting
- Data showed duration effect of 26 weeks, or 6 months, based on
a ≥ 1-point Glabellar Line Scale (GLS) improvement and return to
baseline value using the Global Aesthetic Improvement Scale
Evolus, Inc. (NASDAQ: EOLS), a performance beauty company with a
focus on building an aesthetic portfolio of consumer brands, today
announced that the Aesthetic Surgery Journal has published the
safety and duration of effect results from the Phase 2 study of 40U
Jeuveau® (prabotulinumtoxinA-xvfs) for the treatment of moderate to
severe glabellar lines in adult patients.
The “extra-strength” glabellar line study is a multicenter,
double-blind, randomized, Phase 2 trial following 150 patients for
up to 12 months or until the patient loses their correction. The
study has three arms: Jeuveau® Extra-Strength 40U and two active
controls, BOTOX® 20U and Jeuveau® 20U.
Efficacy 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
safety profile was similar across all three arms and overall, 88.9%
of adverse events were rated as mild and no serious adverse events
were identified.
“This publication provides the details of the study design along
with the efficacy and safety data from the Phase 2 Jeuveau
extra-strength study and makes it accessible to all,” said Dr. Rui
Avelar, MD, Chief Medical Officer and Head of R&D of Evolus.
“The study confirms the correlation between increasing dose and
increasing duration, while maintaining a similar safety profile,
with the majority of adverse events rated as mild.”
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 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 or current facts are
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
market conditions and consumer demand; expectations regarding
regulatory approvals, product launches, and market adoption for
extra-strength formulation of Jeuveau®.
The forward-looking statements included herein are based on our
current expectations, assumptions, estimates and projections, which
we believe to be reasonable, and 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
Medytox Settlement Agreements, our ability to fund our future
operations or obtain financing to fund our operations, unfavorable
global economic conditions and the impact on consumer discretionary
spending, uncertainties related to customer and consumer adoption
of Jeuveau® and Evolysse™, the efficiency and operability of our
digital platform, competition and market dynamics, our ability to
successfully launch and commercialize our products in new markets,
including the Evolysse™ dermal filler product line in the U.S., our
ability to maintain regulatory approvals of Jeuveau® or obtain
regulatory approvals for new product candidates or indications, our
reliance on Symatese to achieve regulatory approval for the
Evolysse™ dermal filler product line in the U.S., and other risks
described in our filings with the Securities and Exchange
Commission, including in the section entitled “Risk Factors” in our
Annual Report on Form 10-K for the year ended December 31, 2023
filed with the Securities and Exchange Commission on March 7, 2024.
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®, Nuceiva®, and Evolysse™ are trademarks of Evolus, Inc.
Hi-Pure™ is a trademark of Daewoong Pharmaceutical Co, Ltd. Estyme®
is a trademark of Symatese Aesthetics S.A.S.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20240417717464/en/
Investors: Nareg Sagherian Vice
President, Head of Global Investor Relations and Corporate
Communications Tel: 248-202-9267 Email: ir@evolus.com
Media: Email: media@evolus.com
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