The FDA has approved Evolus' Evolysse™ Form and Evolysse™ Smooth, two injectable hyaluronic acid gels designed for dermal filling applications. The approval marks the first major technological advancement in hyaluronic acid fillers in a decade and positions Evolus as a multi-product aesthetic company, with a U.S. launch planned for the second quarter of 2025.
Evolysse™ Form and Evolysse™ Smooth incorporate Cold-X™ technology, which is designed to better preserve the hyaluronic acid (HA) molecule's natural structure, providing longer-lasting, natural-looking results, according to Evolus. These products are part of a broader portfolio developed in partnership with Symatese, a biomaterial science company specializing in aesthetic innovations.
The approval follows one of the largest clinical trial programs for an injectable HA technology, with more than 2,000 patients evaluated globally. A U.S. study comparing Evolysse™ Form and Evolysse™ Smooth to Restylane®-L enrolled 140 patients in a double-blind, randomized, active-control split-face trial. Both products met the primary endpoint of non-inferiority, with confidence intervals and p-values less than 0.001 demonstrating statistical superiority. Evolysse™ Form showed statistically significant improvement at all time points over 12 months, while Evolysse™ Smooth demonstrated superiority at six and nine months, despite 20% more Restylane-L being used in the control group.
The safety profile of both products was comparable to Restylane-L, with most adverse events being mild to moderate. No treatment-related serious adverse events or delayed-onset nodules were observed, according to Evolus.
The company previously received EU Medical Device Regulation (MDR) approval for four HA gels under the Estyme® brand, reflecting compliance with European regulatory standards. Evolus is introducing Estyme® through a limited physician experience program in Europe, with a broader commercial launch expected in the second half of 2025.
Reference:
Evolus, Inc. Evolus announces FDA approval of Evolysse™ Form and Evolysse™ Smooth injectable hyaluronic acid gels. Business Wire. February 13, 2025. Available at: 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.
