FDA Approval Announced for 2 New Injectable Hyaluronic Acid, Dermal Filler Gels

An announcement has been published by Evolus, Inc., a company specializing in aesthetic treatments, that the US Food and Drug Administration (FDA) has approved 2 injectable hyaluronic acid gels titled ‘Evolysse Form’ and ‘Evolysse Smooth.’1

In the February 13 announcement, the 2 dermal filler products were described as the first in the Evolysse collection, making the company's first expansion into the hyaluronic acid-containing dermal filler market. The approval follows a recent clinical evaluation of both hyaluronic acid gel products conducted in a pivotal study aimed at treatment of nasolabial folds.

“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,” Michael Kaminer, MD, lead investigator for the study, said in a statement. “These products allow practitioners to achieve precise, natural-looking results, while delivering high patient satisfaction with their effectiveness and longevity.”1

Kaminer and his team of investigators for the US Nasolabial Fold study assessed 140 individuals, using a randomized, double-blind, prospective, active-control split-face trial. They administered each of the 2 products to the participants, performing the procedures, evaluating outcomes, and following a rigorous clinical protocol.

This study involved 140 patients in a double-blind, randomized, active-control split-face trial, where 70 individuals received each of the two new fillers. The results of these fillers were assessed by investigators following a rigorous protocol.

The research team made head-to-head comparisons with Restylane-L, finding that Evolysse Form and Evolysse Smooth both successfully met the study’s primary non-inferiority endpoint. The team’s statistical analysis demonstrated the products’ significant superiority (P < .001).

They identified statistically significant improvements by Evolysse Form over Restylane-L at each of the evaluated time points of the study over its 12-month course. Additionally, they found that Evolysse Smooth outperformed Restylane-L at the 6-month and 9-month marks, adding that the former required 20% less product.

In its assessment of safety, the research team found that Evolysse Form and Evolysse Smooth exhibited a comparable profile to that of Restylane-L. The study indicated that any adverse events were generally mild-to-moderate, with no serious treatment-related side effects noted and no cases of delayed-onset nodules.

Both dermal filler products, according to the announcement, are slated for the second quarter of 2025.

References

1. Evolus Announces FDA Approval of Evolysse™ Form and Evolysse™ Smooth Injectable Hyaluronic Acid Gels. Evolus, Inc. February 13, 2025. https://www.businesswire.com/news/home/20250213924915/en/Evolus-Announces-FDA-Approval-of-Evolysse%E2%84%A2-Form-and-Evolysse%E2%84%A2-Smooth-Injectable-Hyaluronic-Acid-Gels.