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Evolus, Inc. (NASDAQ:EOLS), a performance beauty company with a focus on building an aesthetic portfolio of consumer brands, today announced that it has submitted the final module of its Premarket Approval (PMA) application to the U.S. Food and Drug Administration (FDA) for Evolysse™ Sculpt, an injectable hyaluronic acid (HA) gel product designed to restore mid-face volume.
Evolus anticipates that the FDA's review will follow the standard PMA process, with approval expected in the second half of 2026. The submission underscores Evolus' commitment to bringing its collection of injectable hyaluronic acid gel products to market and its readiness to meet rigorous regulatory requirements.
In support of the PMA application, a U.S. pivotal study which evaluated the safety and effectiveness of the product in a multicenter, double-blinded, controlled, non-inferiority designed trial was conducted. 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 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, which helps preserve the natural structure of the HA molecule for long-lasting, natural-looking results, Sculpt will enter the highest value segment for today's dermal filler market and be among the few products currently indicated for the mid-face area.
Posted In: EOLS
