FDA Approves Evolus' Novel Hyaluronic Acid Dermal Fillers with Superior Efficacy Profile

Key Insights

• Evolus, Inc. receives FDA approval for two new injectable hyaluronic acid dermal fillers, Evolysse Form and Evolysse Smooth, marking their entry into the dermal filler market.
• A pivotal clinical study of 140 patients demonstrated statistical superiority (P < .001) of both Evolysse products compared to Restylane-L in treating nasolabial folds.
• Both products showed comparable safety profiles to Restylane-L with only mild-to-moderate adverse events, and Evolysse Smooth achieved its results using 20% less product.

Evolus, Inc. has secured FDA approval for two innovative injectable hyaluronic acid dermal fillers, Evolysse Form and Evolysse Smooth, marking a significant expansion into the aesthetic dermatology market. The approval follows successful clinical trials demonstrating superior efficacy in treating nasolabial folds compared to existing treatments.

Clinical Trial Results Demonstrate Superior Efficacy

In a rigorous U.S. Nasolabial Fold study, researchers conducted a randomized, double-blind, prospective, active-control split-face trial involving 140 participants. The study, led by Dr. Michael Kaminer, compared both new fillers head-to-head with Restylane-L, a current market standard.

"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," stated Dr. Kaminer, the study's lead investigator. "These products allow practitioners to achieve precise, natural-looking results, while delivering high patient satisfaction with their effectiveness and longevity."

Superior Performance Metrics

Statistical analysis revealed significant advantages for both new products. Evolysse Form demonstrated superior performance compared to Restylane-L consistently throughout the 12-month study period. Notably, Evolysse Smooth showed better results at both 6 and 9-month intervals while requiring 20% less product volume for comparable outcomes.

Safety Profile and Market Impact

The safety assessment revealed comparable profiles between the new products and Restylane-L. Adverse events were predominantly mild to moderate, with no serious treatment-related complications reported. Importantly, no cases of delayed-onset nodules were observed during the study period.

Product Launch Timeline

Evolus plans to launch both dermal filler products in the second quarter of 2025, adding to their portfolio of aesthetic treatments. This strategic expansion into the hyaluronic acid dermal filler market positions Evolus as a more comprehensive provider of aesthetic solutions.