Evolus Inc. announced the submission of its final Premarket Approval (PMA) application to the US Food and Drug Administration for Evolysse Sculpt, an injectable hyaluronic acid gel designed to restore volume in the mid-facial region. The company expects FDA approval in the second half of 2026, which would position the product among the few dermal fillers currently indicated for the mid-face area.
Novel Technology Platform
Evolysse Sculpt represents the most structured product in Evolus's expanding dermal filler portfolio, manufactured using innovative Cold-X technology developed by partner company Symatese. This proprietary technology preserves the natural structure of the hyaluronic acid molecule, leading to more natural-looking and longer-lasting outcomes compared to conventional manufacturing processes.
"Sculpt is our most structured product, manufactured using a novel technology and designed to address mid-face volume loss, a high-value segment in facial aesthetics," said Dr. Rui Avelar, Chief Medical Officer and Head of R&D at Evolus.
Clinical Evidence Supporting Approval
The PMA application is supported by a pivotal US study that evaluated 304 participants in a multicenter, double-blinded, controlled, non-inferiority designed trial. Patients were randomized to receive either Evolysse Sculpt or Restylane-Lyft and were followed for 24 months from the initial treatment date to assess both safety and efficacy outcomes.
This clinical program represents part of one of the largest clinical trial programs undertaken for an injectable hyaluronic acid technology, with Evolysse products being evaluated for safety and effectiveness in over 2,000 patients globally, according to Jean-Paul Gérardin, Chief Executive Officer of Symatese.
Expanding Product Portfolio
The Evolysse Sculpt submission builds upon Evolus's existing FDA-approved dermal filler portfolio, which includes Evolysse Form and Evolysse Smooth, both approved by the FDA in February 2025. These products demonstrated superior performance in head-to-head studies against Restylane-L, meeting primary endpoints of non-inferiority and achieving statistical superiority (p < 0.001).
In the comparative studies, Evolysse Smooth demonstrated clinically meaningful differences at 6 and 9 months, despite 20% more Restylane-L being used in the control group. Over 80% of participants expressed willingness to undergo treatment again and would recommend it to others. The safety profile was positive, with most adverse effects being mild to moderate and no treatment-related serious adverse events reported.
"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," said Dr. Michael Kaminer, lead investigator for one of the pivotal studies.
Market Positioning and Future Pipeline
Evolysse Sculpt is expected to serve as the flagship brand in the Evolysse collection, targeting the highest value segment of today's dermal filler market. The company is also conducting clinical research on Evolysse Lips, with a targeted release for 2027, further expanding its aesthetic injectable portfolio.
The mid-face volume restoration market represents a high-value segment in facial aesthetics, with limited products currently indicated for this specific anatomical area. Evolus's strategic focus on this market segment, combined with its novel manufacturing technology, positions the company to capture significant market share upon approval.
