Evolus, Inc. (NASDAQ: EOLS), a performance beauty company with a
focus on building an aesthetic portfolio of consumer brands, today
announced the completion of its Phase 2 clinical study evaluating
an “extra-strength” dose for extended duration of Jeuveau®
(prabotulinumtoxinA-xvfs), its flagship neurotoxin product and the
first and only neurotoxin dedicated exclusively to aesthetics.
Presentation of the full dataset will be planned for a medical
meeting in Q4 2023.
Interim data presented at the 2023 International Master Course
on Aging Science (IMCAS) World Congress showed Jeuveau
Extra-Strength at 40U (units) demonstrated 6 months (26 weeks)
duration across the three metrics presented, including the time it
takes for patients to return to their baseline Glabellar Line Scale
(GLS) score after their treatment, time back to baseline for
patients with a response of none or mild on the GLS, and the
duration of effect of at least a one-point GLS improvement. The
adverse events profile across all three arms was similar. The
severity rating demonstrated that 88% of the events were mild and
12% were moderate. Importantly, no serious adverse events were
reported.
“Concluding this Phase 2 clinical study marks another
significant milestone for Evolus and our commitment to delivering
continued product innovation,” said Rui Avelar, M.D., Chief Medical
Officer and Head of Research and Development, Evolus. “We were
encouraged by the results of the interim analysis, which took place
midway through the study, and now that all the patients have
completed the study, we are excited to present the final one-year
results, which we believe will demonstrate continued success over
time.”
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.
“Our growing consumer base, especially millennials, demand
products that deliver not only efficacy and safety but also offer
them flexibility with their aesthetic treatments by providing the
option of ‘extra-strength’ in addition to our flagship
‘original-strength’ Jeuveau product,” said David Moatazedi,
President and Chief Executive Officer, Evolus. “The final results
of our completed ‘extra-strength’ study will provide data to help
answer whether Jeuveau’s precision profile can help customers and
their patients achieve their desired results for longer.”
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 has 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 is following 150 patients for
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® Cosmetic – which will be compared to 40 units of Jeuveau.
In addition to evaluating the safety, efficacy and duration of
effect, this study will also help assess the potential clinical
tradeoffs for patients when using the longer duration option.
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), the first and only neurotoxin
dedicated exclusively to aesthetics and 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, Twitter,
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; financial and other benefits
expected from the company’s commercial outlook and its Evolus
Rewards™ program. 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 and our
Quarterly Report on Form 10-Q for the quarter ended March 31, 2023
expected to be filed with the Securities and Exchange Commission on
or about May 9, 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20230621931864/en/
Investors:
David K. Erickson Vice President, Investor Relations Tel:
949-966-1798 Email: david.erickson@evolus.com
Media: Email: media@evolus.com
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