The U.S. Food and Drug Administration (FDA) has approved Evolysse Form and Evolysse Smooth injectable hyaluronic acid (HA) gels, the first two products in Evolus, Inc.’s Evolysse collection.
“This milestone represents an exciting new chapter in our long-term strategy to expand our portfolio and transition from a single-product company to a multi-product innovator, strengthening our leadership in performance beauty,” says David Moatazedi, President and Chief Executive Officer of Evolus, in a news release. “Evolysse Form and Evolysse Smooth represent the first major technological breakthrough in HA dermal fillers in a decade, offering our customers and consumers a new standard in performance and innovation. The launch of these products is a catalyst in our growth as we are focused on achieving at least $700 million in net revenue and non-GAAP operating income margin of at least 20% by 2028.”
Evolus plans to launch Evolysse Form and Evolysse Smooth in the U.S. market in Q2 2025.
Evolysse Form and Evolysse Smooth are part of a collection of injectable HA gels designed by Symatese, which utilizes Cold-X technology that is designed to better preserve the natural structure of the HA molecule for long-lasting, natural-looking results.
The commercial launch of these first two injectable HA gels in 2025 will be followed by Evolysse Sculpt in 2026, and Evolysse Lips in 2027.
“The Evolysse Form and Evolysse Smooth injectable HA gels demonstrated impressive safety, efficacy, and versatility, with the unique property of being injectable at various depths in the skin [in the U.S. Nasolabial Fold (NLF) pivotal study],” says Michael Kaminer, MD, a Dermatologist in Brookline, MA. “These products allow practitioners to achieve precise, natural-looking results, while delivering high patient satisfaction with their effectiveness and longevity.”
Dr. Kaminer was an investigator for the U.S. NLF study for Evolysse Form and Evolysse Smooth. This study included 140 patients in a double-blind, prospective, randomized, active-control split-face trial. Seventy patients were treated with each product, with investigators performing the procedures, evaluating outcomes, and following a rigorous clinical protocol.
Evolysse Form and Evolysse Smooth were evaluated in a head-to-head study with Restylane-L. Both products met the primary endpoint of non-inferiority, and both the confidence intervals as well as the corresponding p-values demonstrated statistical superiority. As assessed by the live, blinded investigators, Evolysse Form showed statistically significant differences compared to Restylane-L at all measured timepoints for the entire 12-month study period. Evolysse Smooth showed statistically significant differences compared to Restylane-L at 6 and 9 months – even though 20% more Restylane-L was used.
In the head-to-head clinical study vs. Restylane-L, the safety profile of Evolysse Form and Evolysse Smooth was similar to the control, with most adverse events being mild to moderate. There were no treatment-related serious adverse events, and no delayed-onset nodules were observed.
Evolus previously announced that EU Medical Device Regulation (MDR) approval was received for four unique injectable hyaluronic acid (HA) gels under the brand name Estyme. Evolus is also introducing Estyme through a limited experience program with select physician partners in Europe. A broader European launch remains on track for the second half of 2025.
