Peer-Reviewed Post Hoc Analysis Shows Jeuveau® is Highly Effective for Millennials by All Measures and at All Time Points Assessed
100% of millennials achieved greater than 1-point improvement on the Glabellar Line Scale on days 7, 14 and 30
100% of millennials were satisfied or very satisfied with treatment on days 7 and 30
Jeuveau® found to be well-tolerated by both millennials and non-millennials
NEWPORT BEACH, Calif., June 02, 2022--(BUSINESS WIRE)--Evolus, Inc. (NASDAQ: EOLS), a performance beauty company with a customer-centric approach focused on delivering breakthrough products, today announced that Dermatologic Surgery published a new post hoc analysis of its Phase III studies comparing millennial patients to non-millennials. The data showed Jeuveau® (prabotulinumtoxinA-xvfs) was well tolerated in both millennial and non-millennial patient populations, and highly effective for millennials with moderate-to-severe glabellar lines.1
Researchers analyzed 737 patients treated with Jeuveau® who participated in three single-dose, Phase III glabellar line clinical studies, comparing millennials (born 1982-2000) to non-millennials (born before 1981). Data showed that millennials achieved higher results across all effectiveness measurements and time periods, hitting statistical significance at several points. On the Glabellar Line Scale at maximum frown, 100% of millennials achieved greater than 1-point improvement on days 7, 14 and 30. Data also showed that responder rates among millennials were greater than those of non-millennials by approximately 7.7% across all visits and were statistically significant on days 7 and 90.1 Patient satisfaction remained high throughout the studies, with 100% of millennials satisfied or very satisfied with their treatment on days 7 and 30. Jeuveau® was similarly well-tolerated by both millennials and non-millennials. The overall incidence of adverse events assessed by the investigator as treatment-related was 16.4% among the millennials and 13.3% in non-millennials, which was not statistically significant.1
"This millennial publication adds to the body of clinical data around this growing patient segment, which has been significantly lacking," said Dr. Jean Carruthers, Cosmetic Surgery, Inc., and lead study investigator. "As younger patients embrace ‘Prejuvenation’ to prevent the signs of aging, it is critical that we understand how they respond to treatment. These results show that not only is Jeuveau® well-tolerated by patients, it also demonstrated higher efficacy values in millennials across every measurable endpoint and every time point."
"Millennial patients have demonstrated an interest in and willingness to adopt therapies to slow the appearance of aging," said Rui Avelar, MD, Chief Medical Officer and Head of Research and Development, Evolus. "Separate publications referenced in this analysis note that in long-term repeat treatment studies over a one-year period where over 90% of patients had wrinkles at rest, over 70% demonstrated an improvement in those wrinkles.2,3 This is suggestive of soft tissue remodeling and may bode well for millennials trying to avoid the formation of wrinkles in the future."
Millennials are a large and growing patient population who consider aesthetic treatments to be a part of normal life.4 While much has been published about millennials in the media in recent years, clinical data remains limited. The millennial publication is the latest in a series of analyses on emerging aesthetic populations, which includes a recent skin of color publication.
"The millennial consumer is the largest and fastest-growing demographic today and represents the single most important growth driver of the aesthetics industry," said David Moatazedi, President and CEO of Evolus. "We have designed the Jeuveau® brand specifically for this younger generation who is increasingly incorporating aesthetic neurotoxin treatment into their everyday beauty regimen. We believe the findings of this analysis validate our millennial-focused strategy and will encourage broader adoption of Jeuveau® among this demographic."
Jeuveau® is used 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® were evaluated in the largest head-to-head pivotal study versus BOTOX® to date, enrolling more than 2,100 patients as part of Evolus’ TRANSPARENCY clinical development program. The product is approved for sale in the United States under the brand name Jeuveau® and in Canada under the brand name Nuceiva®. The company plans to launch Nuceiva® in Europe in the second half of 2022.
About Evolus, Inc.
Evolus (Nasdaq: EOLS) is a performance beauty company with a customer-centric approach to delivering breakthrough products. Approved in 2019 by the U.S. Food and Drug Administration, Jeuveau® (prabotulinumtoxinA-xvfs) is the first and only neurotoxin dedicated exclusively to aesthetics and manufactured in a state-of-the-art facility using Hi-Pure™ technology. Jeuveau® is powered by Evolus’ unique technology platform and is designed to transform the aesthetic market by eliminating the friction points existing for customers today. Visit us at www.evolus.com and follow us on LinkedIn, Twitter, Instagram or Facebook.
This press release contains forward-looking statements as defined under the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including statements that relate to the status of regulatory processes, future plans, events, prospects or performance and statements containing the words "plans," "expects," "believes," "strategy," "opportunity," "anticipates," "outlook," "designed," or other forms of these words or similar expressions, although not all forward-looking statements contain these identifying words. The company’s forward-looking statements include, but are not limited to, statements related to the company’s prospects and business strategies.
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 address all of our losses, costs, expenses, liabilities and damages resulting from the settlement agreement with Daewoong and 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 inflation on our business and the economy generally, uncertainties related to customer and consumer adoption of Jeuveau®, the efficiency and operability of our digital platform, competition and market dynamics, and our ability to maintain regulatory approvals of Jeuveau® 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 fiscal year ended December 31, 2021 filed with the Securities and Exchange Commission on March 3, 2022 and our Quarterly Report on Form 10-Q for the quarter ended March 31, 2022, filed with the SEC on May 10, 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.
Ogilvie P, Jones DH, Avelar RL, Jonker A, Monroe R, Carruthers J. PrabotulinumtoxinA for treatment of millennials with moderate to severe glabellar lines: post hoc analyses of the phase III clinical study data. Dermatol Surg. 2022. doi: 10.1097/DSS.0000000000003456
Kaufman-Janette J, Avelar RL, Biesman BS, Draelos ZD, Gross JE, Jones DH, et al. The first of two one-year, multicenter, open-label, repeat-dose, phase II safety studies of PrabotulinumtoxinA for the treatment of moderate to severe glabellar lines in adult patients. Aesthet Surg J. 2021;41(12):1409-1422. https://doi.org/10.1093/asj/sjaa383
Lorenc ZP, Adelglass JM, Avelar RL, Baumann L, Beer KR, Cohen JL, et al. The second of two one-year, multicenter, open-label, repeat-dose, phase II safety studies of PrabotulinumtoxinA for the treatment of moderate to severe glabellar lines in adult patients. Aesthet Surg J. 2021;41(12):1423-1438. https://doi.org/10.1093/asj/sjaa382
Seery T. Making sense of millennials. Mod Aesthetics. 2016;10:62-4.
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