- Evolus dermal filler, Evolysse™ Lift, met primary endpoint of
non-inferiority and demonstrated superiority to Restylane-L at 6
months; Secondary endpoints for improvement in nasolabial fold
severity showed statistically significant differences compared to
Restylane-L at all measured timepoints for the entire 12-month
study period
- Evolus dermal filler, Evolysse™ Smooth, met primary endpoint of
non-inferiority and demonstrated superiority to Restylane-L at 6
months; Secondary endpoints for improvement in nasolabial fold
severity showed statistically significant differences compared to
Restylane-L at 6 and 9 months
- The safety profiles were similar between the two Evolysse™
dermal filler products and Restylane-L and there were no
treatment-related serious adverse events
- On track to submit Premarket Approval (PMA) applications for
the first two Evolysse™ dermal filler products with the FDA within
the next 90 days
Evolus, Inc. (NASDAQ: EOLS), a performance beauty company with a
focus on building an aesthetic portfolio of consumer brands, today
announced positive topline results from a U.S. pivotal nasolabial
fold (NLF) study of dermal filler products Evolysse™ Lift and
Smooth. Data were presented at the 2024 SCALE Meeting on May 17,
2024, in Nashville.
“Achieving positive topline results in our NLF study is a
pivotal step supporting the upcoming submission of our Premarket
Approval application for the U.S. launch of our dermal filler
lines. Complementing our flagship neurotoxin Jeuveau® – the fastest
growing neurotoxin in the U.S. for the past three years1 – our
Evolysse™ line of dermal fillers expands our total addressable
market by 78%,” said David Moatazedi, President and Chief Executive
Officer.
“Built on the earlier success of the European head-to-head
trial, the consistency of results from this pivotal trial for
Evolysse™ Lift and Smooth were impressive when compared to the
previously shared European nasolabial fold data,” said Dr. Rui
Avelar, MD, Chief Medical Officer and Head of R&D. “The R&D
team remains on track to complete and submit the PMA to the FDA
within the next 90 days and this data increases our confidence in
the submission.”
“As an investigator in this pivotal trial, I had first-hand
experience in treating patients with the new Evolysse™ HA filler
line that is manufactured using a novel “Cold Technology” process
which is aimed at preserving the natural structure of the HA
molecule,” said Dr. Steven Dayan, MD. “Clinically, I found the
product to be precise and I could treat patients to optimal
correction. I was also struck by the fact that despite using the
same amount of product between the treatment and control, there
seems to be more of a difference in the correction when looking at
the Evolysse™ treatment arm.”
Study Design
The U.S. NLF pivotal study was a multicenter, blinded, split
face, controlled, non-inferiority design. Patients were followed
for 12 months from initial treatment. A total of 140 patients were
enrolled and divided evenly across two investigational arms.
Patients were randomized to receive Evolysse™ Lift or Evolysse™
Smooth in one NLF and Restylane-L in the contralateral NLF. This
split face design allowed each individual patient to experience one
of the Evolysse™ fillers and the control at the same time.
The 6-month primary endpoint measured the change in NLF severity
from baseline and was assessed by a blinded independent
photographic review panel using a validated 5-point nasolabial
scale.
Results
The Evolysse™ Lift vs Restylane-L arm met the primary endpoint
of non-inferiority and demonstrated superiority, with a mean NLF
severity score difference of -0.3 (95% CI: -0.500, -0.032,
non-inferiority margin 0.5) and corresponding p-value of 0.03. As a
secondary endpoint, the mean grade change in the NLF severity, as
assessed by the blinded, live evaluator demonstrated a
statistically significant difference (p<0.05) at all timepoints
from 6 weeks to 12 months between Evolysse™ Lift and the
control.
The Evolysse™ Smooth vs Restylane-L arm also met the primary
endpoint of non-inferiority and demonstrated superiority, with a
mean NLF severity score difference of -0.2 (95% CI: -0.416, -0.019,
non-inferiority margin 0.5) and corresponding p-value of 0.02. As a
secondary endpoint, the mean grade change in the NLF severity, as
assessed by the blinded, live evaluator demonstrated a
statistically significant difference (p<0.05) at 6 and 9 months
between Evolysse™ Smooth and the control.
The safety profiles were similar between the two Evolysse™
dermal filler products compared to their respective controls and
there were no treatment-related serious adverse events.
Evolus remains on track to submit Premarket Approval (PMA)
applications for the first two Evolysse™ dermal filler products
with the FDA within the next 90 days. The Evolysse™ Lift filler
will be positioned as the most versatile and highest use filler in
the product line. The Evolysse™ Smooth filler is a softer product
than Lift, providing additional versatility.
1 Measured by comparing year-over-year revenue growth of each
aesthetic neurotoxin on the market for the entirety of each
comparable year.
About Evolus, Inc.
Evolus (NASDAQ: EOLS) is a global 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™, and
the exclusive distributor in Europe of Estyme®, a line of unique
dermal fillers currently in late-stage development. Visit us at
www.evolus.com, and follow us on LinkedIn, X, Instagram or
Facebook.
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
anticipated product launches; market size, conditions and consumer
demand; and the timing of regulatory submissions and approvals.
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 Form and our Quarterly Report on Form
10-Q for the quarter ended March 31, 2024 filed with the Securities
and Exchange Commission on May 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® and Nuceiva®, are registered trademarks and Evolysse™
is a trademark of Evolus, Inc. Hi-Pure™ is a trademark of Daewoong
Pharmaceutical Co, Ltd. Estyme® is a trademark of Symatese
Aesthetics S.A.S. Restylane® is a trademark of Galderma S.A.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20240520622093/en/
Evolus Contacts: 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
Evolus (NASDAQ:EOLS)
Graphique Historique de l'Action
De Nov 2024 à Déc 2024
Evolus (NASDAQ:EOLS)
Graphique Historique de l'Action
De Déc 2023 à Déc 2024
