- “Extra-strength” 40U formulation achieves one-point improvement
on the Glabellar Lines Scale with the duration of effect lasting 26
weeks, representing a prolonged 6-month performance
- Results indicate a favorable safety profile; no serious adverse
events reported and 88% of all adverse events were mild
- Potential new “extra-strength” formulation would expand Evolus'
Jeuveau® offering
- Trial completion expected mid-2023; final results anticipated
to be presented in 2H 2023
Evolus, Inc. (NASDAQ: EOLS), a performance beauty company with a
customer-centric approach focused on delivering breakthrough
products, today presented interim data from its Phase II clinical
study evaluating an "extra-strength" formulation for extended
duration of Jeuveau® (prabotulinumtoxinA-xvfs), its flagship
neurotoxin product, at the 2023 International Master Course on
Aging Science (IMCAS) World Congress in Paris. The data indicated
that the “extra-strength” formulation of Jeuveau® at 40U (units)
achieved a duration profile of 6 months or 26 weeks.
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. An interim analysis was
performed to assess the safety and efficacy of the extra-strength
formulation. At this time, Jeuveau® Extra-Strength has 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.
“The interim results of this study are a significant step
forward in our strategy to provide a longer-duration treatment
option to patients, and we are very pleased that the
‘extra-strength’ formulation of Jeuveau® demonstrated a duration of
6 months or 26 weeks,” said Rui Avelar, M.D., Chief Medical Officer
and Head of Research and Development, Evolus. “These data are very
encouraging from a safety and efficacy perspective as we are seeing
improvement on the GLS scale together with a favorable safety
profile.”
“The combination of results from the ‘original strength’ trials
and this exciting new ‘extra-strength’ data further reinforces
Jeuveau’s® efficacy, offering greater flexibility for clinicians
and patients while maintaining a similar safety profile between the
two formulations,” said David Moatazedi, President and Chief
Executive Officer, Evolus. “‘Extra-strength’ Jeuveau® can be
formulated using the same vial used for the ‘original strength’
Jeuveau® simply by modifying the reconstitution. This provides the
runway for an exciting option for our customers that already value
Jeuveau’s® unique precision profile while delivering
natural-looking results.”
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. The safety and efficacy of Jeuveau® was evaluated
through the company’s TRANSPARENCY program, the largest
head-to-head pivotal study versus BOTOX® to date. The product is
approved for sale in the U.S. under the brand name Jeuveau® and in
Canada under the brand name Nuceiva®, which launched in Europe in
the second half of 2022, 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 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.
Investor Webcast Information
Evolus will host a live conference call and webcast for
investors on Monday, January 30th at 11:30 am Eastern to discuss
the findings. To connect to the webcast, please access the link on
the Events & Presentations page of our website at
www.evolus.com. For audio-only access to the webcast, dial (877)
407-6184 (U.S.) or (201) 389-0877 (international). An archived copy
of the webcast will be available on our website later that day.
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. 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 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 company’s ongoing clinical
trial, related research and development activities and commercial
potential for the “extra-strength” formulation.
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 September 30, 2022 filed with the
Securities and Exchange Commission on November 8, 2022. 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.
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/20230128005004/en/
Investor Contact: David K.
Erickson, Evolus, Inc. Vice President, Investor Relations Tel:
949-966-1798 Email: david.erickson@evolus.com
Media Contact: Email:
media@evolus.com
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