What's Happening?
Evolus, Inc., a performance beauty company, has submitted the final module of its Premarket Approval application to the U.S. Food and Drug Administration for Evolysse Sculpt, an injectable hyaluronic acid gel product. Designed to restore mid-face volume, Sculpt is manufactured using novel technology to address volume loss in facial aesthetics. The submission marks a significant milestone in expanding Evolus's collection of injectable HA gels. A pivotal U.S. study evaluated the product's safety and effectiveness, enrolling 304 patients in a multicenter, double-blinded trial.
AD
Why It's Important?
The submission of the Premarket Approval application for Evolysse Sculpt is crucial for Evolus as it seeks to expand its aesthetic portfolio. Approval of this product could position Evolus as a leader in the high-value segment of facial aesthetics, offering innovative solutions for mid-face volume loss. The successful introduction of Sculpt could enhance Evolus's market presence and drive growth in the competitive dermal filler industry. Meeting FDA regulatory requirements demonstrates Evolus's commitment to safety and effectiveness in its product offerings.
What's Next?
Evolus anticipates the FDA's review will follow the standard PMA process, with approval expected in the second half of 2026. The company will continue to focus on its strategic goals of launching and commercializing its products in new markets. Evolus's collaboration with Symatese for regulatory approval and its readiness to meet rigorous standards will be pivotal in achieving successful product launches. The company aims to maintain its competitive edge in the aesthetic injectable market.
