Evolus Reports Positive Pivotal Trial Data for Evolysse™ Sculpt Hyaluronic Acid Gel at 2025 Cosmetic Bootcamp, Marking a Major Milestone in Aesthetic Innovation
Evolus, Inc. (NASDAQ: EOLS), a fast-growing performance beauty company dedicated to reshaping the aesthetic medicine landscape, announced highly encouraging topline results from its pivotal U.S. clinical trial of Evolysse™ Sculpt, an injectable hyaluronic acid (HA) gel product developed to restore volume and contour in the mid-face. The announcement was made in conjunction with the company’s participation at the 2025 Cosmetic Bootcamp, a premier medical aesthetics education meeting, further underscoring Evolus’ strategic commitment to innovation, physician engagement, and long-term growth in the global aesthetics marketplace.
The pivotal trial results represent an important step forward not only for Evolus’ expanding Evolysse™ collection of dermal fillers but also for its broader mission of offering patients advanced, evidence-backed, and consumer-friendly solutions in the $10 billion-plus U.S. dermal filler market.
Expanding Beyond Jeuveau®: A New Chapter for Evolus
Evolus initially established itself in the performance beauty segment with Jeuveau®, a botulinum toxin product often referred to in the aesthetics industry as “Newtox.” Jeuveau quickly gained traction in the competitive neurotoxin market, offering a consumer-forward brand identity, digital-first marketing, and value-driven pricing compared to established competitors.
The success of Jeuveau laid the foundation for Evolus to evolve from a single-product company into a multi-brand aesthetics portfolio. With Evolysse™, the company is moving decisively into the dermal filler space—a high-value segment where demand continues to climb, fueled by shifting demographics, cultural acceptance of aesthetic procedures, and consumer preferences for minimally invasive treatments.
David Moatazedi, President and Chief Executive Officer of Evolus, highlighted this transition:
“Achieving positive topline results in our mid-face study is an important milestone for Evolus as we expand beyond Jeuveau® with the Evolysse™ line. Evolysse™ Sculpt, the flagship brand in the Evolysse™ collection, targets the highest-value segment of today’s dermal filler market and is among the few products currently indicated for the mid-face area. Its strong performance reinforces our strategy to build a leading performance beauty company with a portfolio designed for today’s aesthetic consumer.”
About Evolysse™ Sculpt: A Flagship in the Making
Evolysse™ Sculpt is being developed as the cornerstone of the Evolysse™ collection, a comprehensive line of injectable HA gel products tailored to different facial applications. Unlike neurotoxins that relax muscle activity to smooth wrinkles, HA fillers add volume, contour, and structural support, helping to restore youthful proportions and correct age-related volume loss.
The product was designed specifically for mid-face augmentation, addressing one of the most requested areas for dermal filler treatment. Mid-face volume restoration not only improves cheek contour but also creates a lifting effect that softens the appearance of nasolabial folds and other age-related changes in the lower face.
What differentiates Evolysse™ Sculpt from existing fillers is its manufacturing process. The product is developed using Cold-X™ technology, an innovative approach pioneered by Symatese, which is designed to preserve the natural structure of HA molecules. This process may translate into improved handling properties for injectors, as well as more natural, durable outcomes for patients—two of the most sought-after characteristics in the aesthetics field.
Dr. Rui Avelar, Chief Medical Officer and Head of R&D at Evolus, emphasized the product’s potential:
The Evolysse™ Sculpt study in patients seeking cheek augmentation demonstrated high patient satisfaction and a similar safety profile to the control. We are pleased to have recently submitted our Premarket Approval (PMA) application to the U.S. Food and Drug Administration (FDA) and look forward to the next phase of bringing this innovative product to patients and practitioners in the U.S.”
Insights From Clinical Investigators
Investigators participating in the pivotal study also voiced strong confidence in the product’s performance.
Dr. Gilly Munavalli, MD, MHS, one of the lead clinical investigators, described his experience:
“As an investigator in this pivotal study, I was impressed by the durability of results and high levels of patient satisfaction achieved with Evolysse™ Sculpt. The product handled exceptionally well during injection, delivering the lift and contouring in the mid-face we seek in daily practice. Manufactured using innovative Cold-X™ technology, which is intended to preserve the natural structure of the HA molecule, I believe Evolysse™ Sculpt has the potential to be a valuable option for patients seeking long-lasting, natural-looking results.”
Such endorsements from key opinion leaders (KOLs) within aesthetics not only strengthen the clinical profile of the product but also position Evolus favorably for eventual market adoption among physicians.
Study Design: A Rigorous Pivotal Trial
The U.S. mid-face pivotal trial was meticulously designed to meet FDA regulatory standards. Conducted as a multicenter, double-blinded, controlled, non-inferiority trial, the study aimed to evaluate both the safety and effectiveness of Evolysse™ Sculpt compared with an established dermal filler control, Restylane®-Lyft.
Key features of the study included:
- Patient Enrollment: 304 patients were randomized to receive either Evolysse™ Sculpt or Restylane®-Lyft.
- Follow-Up Duration: Patients were monitored for up to 24 months after initial treatment, providing valuable long-term safety and durability data.
- Primary Endpoint: Change in mid-face volume deficit severity from baseline at 6 months, assessed using a validated 5-point photo-numeric scale by blinded evaluators.
- Secondary Endpoints: Clinically meaningful improvements in mid-face volume (≥ 1-point improvement on the scale), patient satisfaction, and overall responder rates.
This study design not only provided a robust dataset for FDA review but also set a high bar for comparative effectiveness against one of the leading HA fillers on the market.
Results: Efficacy and Safety Highlights
The topline results demonstrated clear success for Evolysse™ Sculpt:
- Primary Endpoint Achieved: Evolysse™ Sculpt met the non-inferiority requirement and demonstrated statistical superiority versus Restylane®-Lyft. The mean score difference in mid-face volume deficit severity was -0.26 (95% CI [ -0.45, -0.07]) with a p-value of <0.001.
- Secondary Endpoint Success: Evolysse™ Sculpt also outperformed the control in responder rates. At 6 months, 90.9% of treated cheeks demonstrated a clinically meaningful improvement compared to 83.3% for Restylane®-Lyft (p = 0.015).
- Safety Profile: The safety profile was comparable between Evolysse™ Sculpt and the control, with no treatment-related serious adverse events reported. Common side effects were consistent with those typically seen with dermal fillers, such as swelling, bruising, and injection-site reactions, all of which were transient.
The combination of superior efficacy, high patient satisfaction, and favorable safety outcomes strengthens the case for Evolysse™ Sculpt as a differentiated entrant into the mid-face filler market.
Regulatory Pathway: PMA Submission to FDA
On August 20, Evolus formally submitted its Premarket Approval (PMA) application to the FDA, a key milestone required for HA dermal fillers to enter the U.S. market. The company expects the FDA’s review process to follow the standard PMA timeline, with anticipated approval in the second half of 2026.
For Evolus, the PMA submission underscores:
- Regulatory Preparedness – The company is demonstrating the ability to meet the FDA’s stringent requirements, which enhances credibility with investors, physicians, and consumers.
- Pipeline Momentum – Evolysse™ Sculpt is just the beginning of the Evolysse™ collection, signaling that Evolus is well on its way to diversifying its aesthetics pipeline.
- Market Entry Strategy – With FDA approval potentially less than two years away, Evolus is laying the groundwork for U.S. commercialization, including physician education, branding campaigns, and targeted consumer engagement.
Strategic Significance of Evolysse™ Sculpt
The launch of Evolysse™ Sculpt—if approved—could be transformative for Evolus in several ways:
- Portfolio Diversification: Expanding beyond Jeuveau reduces reliance on a single product and establishes Evolus as a multi-faceted aesthetics company.
- Market Positioning: Entering the mid-face filler segment positions Evolus in one of the highest-value categories in aesthetics.
- Competitive Differentiation: The Cold-X™ technology platform offers a novel value proposition, potentially setting Evolysse™ apart from established competitors like Allergan’s Juvederm® line and Galderma’s Restylane®.
- Revenue Growth Potential: Given the strong consumer demand for dermal fillers, Evolysse™ Sculpt could represent a major new revenue stream and strengthen Evolus’ market share.
The Future of the Evolysse™ Collection
Evolysse™ Sculpt is expected to serve as the flagship product of the Evolysse™ collection, but Evolus’ ambitions extend further. The full Evolysse™ portfolio is designed to address multiple facial areas with HA-based solutions tailored for specific indications—mirroring strategies used successfully by leading aesthetics companies.
The combination of Jeuveau® in neurotoxins and Evolysse™ in dermal fillers positions Evolus to compete head-to-head with the “big three” in aesthetics—Allergan Aesthetics (AbbVie), Galderma, and Revance—while continuing to differentiate itself through a consumer-first approach that emphasizes accessibility, transparency, and brand recognition.
A Defining Moment for Evolus
The announcement of positive pivotal trial results for Evolysse™ Sculpt at the 2025 Cosmetic Bootcamp represents more than just a clinical milestone—it is a defining moment for Evolus’ strategic evolution. With compelling efficacy data, high patient satisfaction, a strong safety profile, and a clear regulatory pathway ahead, Evolus is on track to broaden its portfolio and reinforce its role as a disruptive force in the aesthetics industry.
As Evolus looks ahead to potential FDA approval in 2026, the company is positioning itself to capture greater market share, strengthen its relationships with providers, and meet the growing demands of consumers seeking minimally invasive, natural-looking facial enhancement solutions.
If successful, Evolysse™ Sculpt may not only become a cornerstone of Evolus’ product suite but also a game-changer for the aesthetics field, offering patients and practitioners a new standard of care in mid-face augmentation.
