Evolus Announces Positive Data From Pivotal Trial for Evolysse™ Sculpt Injectable Hyaluronic Acid Gel Product at 2025 Cosmetic Bootcamp

• Evolysse^™ Sculpt met the primary endpoint of non-inferiority and demonstrated statistical superiority to Restylane^®-Lyft
• The safety profile was similar between Evolysse^™ Sculpt and Restylane^®-Lyft and no treatment-related serious adverse events
• Premarket Approval application submitted to the U.S. Food and Drug Administration; Approval expected in the second half of 2026

NEWPORT BEACH, Calif.--(BUSINESS WIRE)-- 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 study of Evolysse^™ Sculpt, an injectable hyaluronic acid (HA) gel product designed to restore mid-face volume.

“Achieving positive topline results in our mid-face study is an important milestone for Evolus as we expand beyond Jeuveau^® with the Evolysse^™ line,” said David Moatazedi, President and Chief Executive Officer. “Evolysse^™ Sculpt, the flagship brand in the Evolysse^™ collection, targets the highest-value segment of today’s dermal filler market and is among the few products currently indicated for the mid-face area. Its strong performance reinforces our strategy to build a leading performance beauty company with a portfolio designed for today’s aesthetic consumer.”

“The Evolysse^™ Sculpt study in patients seeking cheek augmentation demonstrated high patient satisfaction and a similar safety profile to the control,” said Dr. Rui Avelar, MD, Chief Medical Officer and Head of R&D. “We are pleased to have recently submitted our Premarket Approval (PMA) application to the U.S. Food and Drug Administration (FDA) and look forward to the next phase of bringing this innovative product to patients and practitioners in the U.S.”

“As an investigator in this pivotal study, I was impressed by the durability of results and high levels of patient satisfaction achieved with Evolysse^™ Sculpt,” said Dr. Gilly Munavalli, MD, MHS. “The product handled exceptionally well during injection, delivering the lift and contouring in the mid-face we seek in daily practice. Manufactured using innovative Cold-X^™ technology, which is intended to preserve the natural structure of the HA molecule, I believe Evolysse^™ Sculpt has the potential to be a valuable option for patients seeking long-lasting, natural-looking results.”

Study Design

The U.S. mid-face pivotal study was a multicenter, double-blinded, controlled, non-inferiority design. Patients were followed for 24 months from initial treatment. A total of 304 patients were enrolled and randomized to receive Evolysse^™ Sculpt or Restylane^®-Lyft.

The 6-month primary endpoint measured the mean grade change in mid-face volume deficit from baseline and was assessed by a blinded, live evaluator using a validated 5-point photo-numeric scale.

Results

The Evolysse^™ Sculpt injectable HA gel product met its primary endpoint of non-inferiority and demonstrated statistical superiority versus Restylane^®-Lyft, with a mean mid-face volume deficit severity score difference of -0.26 (95% CI [ -0.45, -0.07]; non-inferiority margin 0.5) and corresponding p-value of <0.001. The secondary endpoint was also met, demonstrating statistical superiority against Restylane^®-Lyft at 6 months, based on the percent of cheeks demonstrating a clinically meaningful improvement, defined as ≥ 1 point improvement in mid-face volume deficit scale. The Evolysse^™ Sculpt responder rate was 90.9%, [389/428] as compared to Restylane^®-Lyft with 83.3% [110/132], and a p-value 0.015.

The safety profile was similar between Evolysse^™ Sculpt and Restylane^®-Lyft and there were no treatment-related serious adverse events

Evolus anticipates that the FDA’s review process will follow the standard PMA timeline, with approval expected in the second half of 2026. The submission, announced on August 20^th, underscores Evolus’ commitment to bringing its collection of injectable hyaluronic acid gel products to market and its readiness to meet rigorous regulatory requirements.

The Evolysse^™ Sculpt injectable HA gel product is expected to be the flagship brand in the Evolysse^™ collection. Designed by Symatese using innovative Cold-X^™ technology, it is intended to preserve the natural structure of the HA molecule for long-lasting, natural-looking results.

About Evolus, Inc.

Evolus (NASDAQ: EOLS) is a global performance beauty company redefining the aesthetic injectable 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 leader in aesthetics anchored by our flagship products: Jeuveau^® (prabotulinumtoxinA-xvfs), the first and only neurotoxin dedicated exclusively to aesthetics, and Evolysse^™, a collection of unique injectable hyaluronic acid (HA) gels. 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, consumer and customer acceptance of such products, 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 and our Quarterly Report on Form 10-Q for the quarter ended June 30, 2025 filed with the Securities and Exchange Commission on August 5, 2025. 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^® is a registered trademark and Evolysse^™ is a trademark of Evolus, Inc.
Cold-X^™ and Estyme^® are trademarks of Symatese Group and Symatese Aesthetics S.A.S.
Restylane^® is a trademark of Galderma S.A.

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Evolus Contacts:

Investors:

Nareg Sagherian

Vice President, Head of Global Investor Relations and Corporate Communications

Tel: 248-202-9267

Email: ir@evolus.com



Media:

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Source: Evolus