Evolus Announces Results from European Head-to-Head Filler Trial
01 Mars 2024 - 2:30PM
Business Wire
- Evolus dermal filler product (Evolysse™/Estyme® Lift)
demonstrates statistical superiority at 3 and 6 months compared to
Restylane-L with respect to improvement in nasolabial fold
severity
- The European Lift study met the primary endpoint of
non-inferiority
Evolus, Inc. (NASDAQ: EOLS), a performance beauty company with a
focus on building an aesthetic portfolio of consumer brands, today
announced that it will provide the data presented at IMCAS during
its upcoming Earnings conference call on March 7th at 4:30 p.m.
ET.
Evolus remains on track for the global commercial launch of the
first-generation Cold HA Technology in 2025. The filler line will
be branded Evolysse™ in the US and Estyme® in the UK and Europe.
The Evolysse™/Estyme® Lift filler will be positioned as the most
versatile and highest volume filler in the product line. Lift is CE
Marked in Europe and will be filed with the FDA in the summer of
2024 with approval expected in 2025.
The European Lift study was blinded, randomized, 9 months in
duration, and enrolled 45 patients. The study was a split face
design, in which each patient received Estyme® Lift on one side and
the control, Restylane-L, on the other side. Using a validated
5-point scale, the change in Nasolabial Fold (NLF) severity from
baseline was measured. The primary endpoint of non-inferiority was
met at 4 weeks, with the results favoring Estyme® Lift, and at 3
and 6 months, Estyme® Lift achieved statistical superiority over
Restylane-L. The safety profiles were similar and there were no
treatment related serious adverse events.
“The Evolysse™/Estyme® product line is the first filler made
with the proprietary Cold-HA manufacturing process which is
designed to better preserve the natural structure of the HA
molecule, the building block for the entire line of fillers,” said
Dr. Rui Avelar, MD, Chief Medical Officer and Head of R&D.
“Lift represents one of the first Evolysse™ fillers that we will
introduce in the US, and we believe this data is supportive of the
performance benefits of the technology.”
“As the lead investigator in the US NLF trial, I have had
first-hand experience injecting Evolysse™ Lift,” said Dr. Michael
Kaminer, MD. “The product is extremely versatile and forgiving,
with the unique property of being injectable at various depths in
the skin. Post injection recovery was rapid, and the product has a
nice ability to retain a 1:1 correction, providing both longevity
and stable outcomes. The natural quality of the post-treatment
aesthetic results with Evolysse™ Lift are impressive.”
In 2023 Evolus entered into two agreements with Symatese to be
the exclusive distributor of a novel dermal filler line in
late-stage development, the first agreement for the United States
under the brand name Evolysse™ and the second agreement for the
United Kingdom and Europe under the brand name Estyme®. As a result
of these agreements, the company has increased its addressable
market by 78% to approximately $6 billion.
To participate in the fourth quarter earnings conference call,
dial (877) 407-6184 (U.S.) or (201) 389-0877 (international) or
connect live via webcast on the Investor Relations page of the
Evolus website here.
Following the completion of the call, a telephonic replay can be
accessed by dialing (877) 660-6853 (U.S.) or (201) 612-7415
(international) and using conference number 13743722. An archived
webcast can also be accessed on the Investor Relations page of the
Evolus website at www.evolus.com.
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™, 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.
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.
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version on businesswire.com: https://www.businesswire.com/news/home/20240301797950/en/
Investors: Nareg Sagherian, Vice
President, Head of Global Investor Relations and Corporate
Communications Phone: (248) 202-9267 Email: ir@evolus.com
Media: Email: media@evolus.com
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