One newly approved HA filler showed statistical superiority to Restylane-L at all measured time points over 12 months, while the other was superior at six and nine months despite 20% more Restylane-L being used.

Summary

The FDA has approved Evolysse Form and Evolysse Smooth, marking Evolus’ entry into the US HA filler market. These injectable hyaluronic acid (HA) gels, developed by Symatese, utilize Cold-X technology to better preserve the HA molecule’s natural structure for longer-lasting, natural-looking results. A head-to-head clinical trial compared Evolysse Form and Evolysse Smooth to Restylane-L, finding that Evolysse Form was statistically superior at all measured time points over 12 months, while Evolysse Smooth was superior at six and nine months, even though 20% more Restylane-L was used. The safety profile of both fillers was comparable to Restylane-L, with no treatment-related serious adverse events or delayed-onset nodules. Evolus plans to launch the products in Q2 2025.

Key Takeaways

  1. FDA Approves Evolysse Form and Evolysse Smooth – Evolus has received FDA approval for its first HA dermal fillers, developed in partnership with Symatese and featuring Cold-X technology for enhanced longevity.
  2. Head-to-Head Trial Shows Superiority Over Restylane-L – Evolysse Form demonstrated statistical superiority at all time points over 12 months, while Evolysse Smooth was superior at six and nine months, even with less product used.
  3. Evolysse Collection Set to Launch in Q2 2025 – Evolus will introduce its HA filler line to the US market later this year.

Evolus Inc announced that the US Food and Drug Administration (FDA) has approved Evolysse Form and Evolysse Smooth injectable hyaluronic acid (HA) gels, the first two products in the Evolysse collection, marking the company’s entry into the US HA dermal filler market.

Evolysse Form and Evolysse Smooth are part of a collection of injectable HA gels designed by Symatese, which utilizes innovative Cold-X technology that is designed to better preserve the natural structure of the HA molecule for long-lasting, natural-looking results. 

“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,” says David Moatazedi, president and chief executive officer of Evolus, in a release.

Head-to-Head Study With Restylane-L

The US Nasolabial Fold pivotal study for Evolysse Form and Evolysse Smooth 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.

The US Food and Drug Administration has approved Evolysse Form and Evolysse Smooth injectable hyaluronic acid gels. Photo credit: Evolus

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 (<0.001) demonstrated statistical superiority.

As assessed by the live, blinded investigators, Evolysse Form showed statistically significant differences compared to Restylane-L at all measured time points for the entire 12-month study period. Evolysse Smooth showed statistically significant differences compared to Restylane-L at six and nine months, even though 20% more Restylane-L was used.

In the head-to-head clinical study versus 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.

Michael Kaminer, MD, lead investigator for the US NLF pivotal study, says in a release, “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. These products allow practitioners to achieve precise, natural-looking results while delivering high patient satisfaction with their effectiveness and longevity.”

Evolus plans to launch Evolysse Form and Evolysse Smooth in the US market in Q2 2025.

Photo caption: Evolysse Form and Evolysse Smooth

Photo credit: Evolus