Evolus Submits Evolysse Sculpt for FDA Approval, Expanding HA Dermal Filler Portfolio

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Today, Evolus Inc. announced that it has submitted the final module of its Premarket Approval (PMA) application to the US Food and Drug Administration (FDA) for Evolysse Sculpt.¹ The injectable hyaluronic acid gel is for patients looking to restore volume in the mid-facial region.

“This submission represents an important milestone in expanding our Evolysse collection of injectable HA gels,” said Rui Avelar, MD, Chief Medical Officer and Head of R&D at Evolus. “Sculpt is our most structured product, manufactured using a novel technology and designed to address mid-face volume loss, a high-value segment in facial aesthetics.”¹

This application is supported by a pivotal multicenter, double-blinded, controlled, non-inferiority designed study in the US. In the trial, 304 participants were randomized to receive either Evolysse Sculpt or Restylane-Lyft. Patients were evaluated for 24 months after the initial treatment date to determine safety and efficacy.

Evolysse Sculpt utilizes a unique Cold-X technology developed by Symatese, which preserves the natural structure of the hyaluronic acid molecule and leads to more natural-looking and longer-lasting outcomes. The company is expecting an FDA approval in the second half of 2026, making it one of the few products in the dermal filler market currently indicated for the mid-face area.

This addition would build upon the existing portfolio of Evolysse products: Evolysse Form and Evolysse Smooth. These variations were approved by the FDA in February of this year, with a commercial launch to follow.² Evolus is also conducting clinical research on Evolysse Lips, with a targeted release for 2027.

“We are proud to partner with Evolus in bringing the Evolysse collection of injectable HA gels to the U.S. market. With decades of experience in biomaterial science and aesthetics, Symatese has a strong legacy of developing innovative aesthetic products that meet the evolving needs of practitioners and their patients. With one of the largest clinical trial programs undertaken for an injectable HA technology, Evolysse products are being evaluated for safety and effectiveness in over 2,000 patients globally,” said Jean-Paul Gérardin, Chief Executive Officer of Symatese.²

Evolysse Form and Evolysse Smooth were evaluated in a head-to-head 12-month study with Restylane-L. Both products met the primary endpoint of non-inferiority and were statistically superior compared to Restylane-L (p < 0.001). Evolysee Smooth in particular demonstrated clinically meaningful differences at 6 and 9 months, even though 20% more Restylane-L was used. The FACE-Q and Global Aesthetic Improvement Scale evaluations demonstrated sustained improvements in both products throughout the entire trial.

Over 80% of participants expressed that they would undergo treatment again and would recommend it to a friend. The safety profile of Evolysse Form and Evolysse Smooth was positive, with most adverse effects being mild to moderate and no treatment-related serious adverse events. No delayed-onset nodules occurred either, compared to 1.4% in the control arm of the study. Michael Kaminer, MD, lead investigator for one of the pivotal studies, commented on the results in a recent statement.

“The Evolysse Form and Evolysse Smooth injectable HA gels demonstrated impressive safety, efficacy, and versatility, with the unique property of being injectable at various depths in the skin. These products allow practitioners to achieve precise, natural-looking results, while delivering high patient satisfaction with their effectiveness and longevity,” Kaminer said.²

References

1. Evolus Announces Submission of Premarket Approval Application to the U.S. Food and Drug Administration for Evolysse™ Sculpt Injectable Hyaluronic Acid Gel Product. News release. Business Wire. Published August 20, 2025. Accessed August 20, 2025. https://www.businesswire.com/news/home/20250818666368/en/Evolus-Announces-Submission-of-Premarket-Approval-Application-to-the-U.S.-Food-and-Drug-Administration-for-Evolysse-Sculpt-Injectable-Hyaluronic-Acid-Gel-Product

2. Evolus Announces FDA Approval of Evolysse™ Form and Evolysse™ Smooth Injectable Hyaluronic Acid Gels. News release. Evolus. Published February 13, 2025. Accessed August 20, 2025. https://investors.evolus.com/press-releases-and-news/news-details/2025/Evolus-Announces-FDA-Approval-of-Evolysse-Form-and-Evolysse-Smooth-Injectable-Hyaluronic-Acid-Gels/default.aspx