Evolus Successfully Completes Patient Enrollment in Phase II Clinical Study Evaluating “Extra-Strength” Dose of Jeuveau®
Program designed to offer consumers a new “Extra-Strength” dosing option
“Completing patient enrollment represents another important milestone for
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.
“While our customers believe the original 20-unit dose will continue to comprise the majority of use, they are interested in an extra-strength dosing option of Jeuveau® to further customize treatments and meet the diverse needs of a broader patient population,” said
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
About
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, customer and consumer acceptance of an “extra strength” product, study milestones, regulatory approvals and commercial launch.
Forward-looking statements involve risks and uncertainties that could cause actual results or experiences to differ materially from those expressed or implied by the forward-looking statements. Factors that could cause actual results or experience to differ materially from that expressed or implied by the forward-looking statements include the ability to successfully complete the Phase II clinical trial, ability to achieve FDA approval and ultimate commercial acceptability and pricing for an “extra strength” Jeuveau® dose, 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, the continued impact of COVID-19 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 approval of Jeuveau® and other risks described in Evolus’ filings with the
Jeuveau® and Nuceiva® are registered trademarks of
Hi-Pure™ is a trademark of Daewoong Pharmaceutical Co, Ltd.
BOTOX® is a registered trademark of
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Investor Contact:
Vice President, Investor Relations
Tel: 949-966-1798
Email: david.erickson@evolus.com
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President/CEO,
Tel: 562-304-0301
Email: asampson@sampsonprgroup.com
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