Evolus Announces Submission of Premarket Approval Application to the U.S. Food and Drug Administration for First Two Evolysse™ Dermal Filler Products
“We are pleased to have submitted the final module of the PMA application,” said Dr.
The PMA application includes results from the
Both the Evolysse™ Lift and Evolysse™ Smooth dermal filler products met their primary endpoint of non-inferiority and demonstrated superiority to Restylane-L at 6 months. More information on the study is available here.
The Evolysse™ Lift filler will be positioned as the most versatile for treating facial wrinkles and folds (such as NLFs) and is expected to be the highest use filler in the product line. The Evolysse™ Smooth filler will be positioned as an alternative softer formulation option to Evolysse™ Lift.
About
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 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
Jeuveau® and Nuceiva® are registered trademarks and Evolysse™ is a trademark of
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
View source version on businesswire.com: https://www.businesswire.com/news/home/20240624339161/en/
Evolus Contacts:
Investors:
Vice President, Head of Global Investor Relations and Corporate Communications
Tel: 248-202-9267
Email: ir@evolus.com
Media:
Email: media@evolus.com
Source: