Evolus announces Evolysse Sculpt trial meets primary endpoint

Evolus (EOLS) announced topline results from a U.S. pivotal study of Evolysse Sculpt, an injectable hyaluronic acid gel product designed to restore mid-face volume. 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 and corresponding p-value of less than 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% 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 20th, 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.