FDA Approves Two New Hyaluronic Acid Dermal Fillers

Evolus, Inc. has announced FDA approval for two new injectable hyaluronic acid gels, Evolysse Form and Evolysse Smooth. These products mark the company's entry into the hyaluronic acid dermal filler market, providing dermatologists with additional options in aesthetic treatments.

These approvals mark Evolus’ entry into the U.S. HA dermal filler market and solidifies the company’s position as a multi-product innovator in aesthetics, expanding Evolus’ total addressable market by 78% to approximately $6 billion.

“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,” said David Moatazedi, President and Chief Executive Officer of Evolus. “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. This launch will leverage Evolus’ scalable cash-pay business model and existing digital infrastructure, creating tremendous synergy with the company’s fast-growing neurotoxin business and driving significant value for both customers and consumers.

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. 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.

“We are proud to partner with Evolus in bringing the Evolysse™ collection of injectable HA gels to the U.S. market. With decades of experience in biomaterial science and aesthetics, Symatese has a strong legacy of developing innovative aesthetic products that meet the evolving needs of practitioners and their patients. With one of the largest clinical trial programs undertaken for an injectable HA technology, Evolysse™ products are being evaluated for safety and effectiveness in over 2,000 patients globally,” said Jean-Paul Gérardin, Chief Executive Officer of Symatese.

Dr. Rui Avelar, Evolus Chief Medical Officer and Head of R&D, added, “The FDA approval of Evolysse™ Form and Evolysse™ Smooth reflects our commitment to bringing high-quality, innovative aesthetic products to market. These additions to our portfolio reinforce Evolus’ dedication to the highest standards of patient safety and efficacy. With the introduction of Cold-X™ technology, Evolysse™ offers a differentiated approach to the dermal filler category, providing healthcare practitioners with new options to address the unique needs of their patients with precision and confidence.”

Dr. Michael Kaminer, MD, lead investigator for the U.S. NLF pivotal study and an internationally recognized expert in cosmetic surgery, commented, “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.” The U.S. Nasolabial Fold (NLF) 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.

Evolysse™ Form and Evolysse™ Smooth were evaluated in a head-to-head study with Restylane®-L. Both products met the primary endpoint of non-inferiority3, 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 differences4 compared to Restylane-L at all measured timepoints for the entire 12-month study period. Evolysse™ Smooth showed statistically significant differences4 compared to Restylane-L at 6 and 9 months – even though 20% more Restylane-L was used5.

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.

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® (pronounced “esteem”), reflecting the product’s compliance with the highest regulatory standards. Evolus is also introducing Estyme® through a limited experience program with select physician partners in Europe, to continue to expand global experience with the product’s performance. A broader European launch remains on track for the second half of 2025, further expanding Evolus’ footprint into the global dermal filler market and reinforcing its position as a leader in performance beauty.