Evolus, Inc. 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 for restoring 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.
In support of the PMA application, researchers conducted a U.S. pivotal study that evaluated the safety and effectiveness of the product in a multicenter, double-blinded, controlled, non-inferiority designed trial. 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, Sculpt will be among the few products currently indicated for the mid-face area.
