What Is Evolysse™? The First FDA-Approved HA Filler in a Decade
- Juvenology Clinic
- Apr 23
- 7 min read
Updated: May 1
Overview of Evolysse™ Form and Smooth
Key Benefits of Evolysse™ Injectable HA Fillers
FDA Approval: A Major Milestone
What FDA Approval Means for Evolysse™
Upcoming Evolysse™ Product Launches
Cold-X™ Technology: A Game Changer in Aesthetic Treatments
How Cold-X™ Technology Enhances HA Fillers
Advantages of Cold-Preservation in Gel Formulation
Clinical Validation: Research Behind the Approval
Clinical Study Results for Evolysse™ Form
Comparison with Industry-Leading Fillers
Safety and Efficacy: What the Data Shows
Common Side Effects and Safety Profile
Patient Satisfaction and Long-Term Results
How Evolysse™ Compares to Other HA Fillers
Evolysse™ vs Juvéderm®
Evolysse™ vs Restylane®
Unique Features of Evolysse™ Fillers
What This Means for Aesthetic Practitioners
Practitioner Benefits and Ease of Use
How Evolysse™ Enhances Client Satisfaction
What is Evolysse™?
At the heart of Evolus’ latest innovation is the Evolysse™ collection – a family of injectable HA fillers designed to treat a range of aesthetic concerns, from volume loss to surface-level smoothing. The initial FDA-approved products, Evolysse™ Form and Evolysse™ Smooth, are tailored for different depths and treatment areas but share the same science-backed foundation.
Evolysse™ Form is crafted for moderate to severe facial wrinkles and folds – think nasolabial folds and marionette lines. It’s got a bit more structure, making it ideal for areas where you want support and lift.
Evolysse™ Smooth, on the other hand, is lighter and more flexible. It’s perfect for refining surface texture, filling fine lines, or even treating delicate areas where a softer touch is key.
What sets these fillers apart is their formulation: a cold-preserved hyaluronic acid gel developed with Cold-X™ technology. By processing the gel at low temperatures, the product retains more of HA’s natural molecular structure, resulting in a smoother texture, improved integration, and longer-lasting results compared to traditional heat-processed gels.
For clients, this means more natural movement, less risk of lumpiness, and a refreshed look that blends beautifully with the surrounding skin. For practitioners, it’s a chance to work with an advanced filler technology that gives precision and flexibility without compromising on safety or outcome.
In short? Evolysse™ isn’t just another filler line – it’s a new generation of hyaluronic acid injections built with both science and artistry in mind.
2. FDA Approval: A Major Milestone
Evolus has achieved with Evolysse™ Form and Evolysse™ Smooth.
After extensive clinical studies, the U.S. Food and Drug Administration gave the green light to these injectable dermal fillers in early 2025. This marks a pivotal moment for Evolus, allowing the brand to formally enter the U.S. dermal filler market — a highly competitive space dominated by established names like Restylane® and Juvéderm®.
So why is this approval such a big deal?
First, it signals that Evolysse™ meets strict regulatory standards for efficacy, consistency, and safety.
Second, it’s a strategic expansion that helps Evolus evolve from being just the Jeuveau® brand into a more complete aesthetic solutions provider.
And third — perhaps most exciting for practitioners — the approval includes a clear timeline for broader product rollout:
Evolysse™ Form and Smooth: U.S. launch planned for Q2 2025
Evolysse™ Sculpt (for deeper structural volume): Coming in 2026
Evolysse™ Lips (for lip augmentation): Expected 2027
For those offering injectable treatments, this opens up a suite of new options with a modern formulation profile that’s been designed for both performance and patient comfort.
3. Cold-X™ Technology: A Game Changer in Aesthetic Treatments
Let’s talk tech because this is where Evolysse™ really shines.
At the core of both Evolysse™ Form and Evolysse™ Smooth lies a proprietary innovation called Cold-X™ technology. This isn’t just a fancy name, it refers to a cold-preservation manufacturing process that carefully protects the natural structure of hyaluronic acid (HA) molecules during gel formation.
So what does that mean in practice?
Softer, more flexible gels that blend seamlessly into the skin.
More intact HA chains, which translates to improved water retention and plumpness.
Longer-lasting results, patients can enjoy their smoother, fuller look for months on end with fewer touch-ups.
Compared to conventional fillers that rely on high-heat processing (which can degrade the HA), Cold-X™ helps maintain the integrity and elasticity of the gel. This gives practitioners a product that not only handles beautifully during injection but also integrates more naturally once it’s under the skin.
It’s the kind of advanced filler technology that’s perfect for today’s clients, those who want results that are visible, but not obvious. Whether it’s for contouring, softening lines, or just giving the face a little “glow up,” Cold-X™-based hyaluronic acid gel injections offer a refined alternative to older, stiffer fillers.
And when you pair that innovation with the strong safety profile and tailored consistency of each formulation? You get a filler line that’s not just competing with the best, it’s setting a new benchmark.
4. Clinical Validation: Research Behind the Approval
Behind every FDA approval is a mountain of data and Evolysse™ passed the test with flying colours.
To earn its place among the most trusted names in injectable dermal fillers, Evolysse™ Form underwent a pivotal clinical study designed to prove it could stand shoulder to shoulder with an industry favourite: Restylane®-L.
This non-inferiority comparison wasn't just a box-ticking exercise. It was a deep dive into how the product performed across real-world applications — specifically for moderate to severe nasolabial folds, one of the most commonly treated areas with HA fillers.
The results?
Evolysse™ Form met the study’s primary endpoints, showing comparable results to Restylane®-L in terms of wrinkle reduction and lift.
It also passed the secondary benchmarks, including patient satisfaction scores, aesthetic improvement ratings, and durability of outcomes over time.
And just as crucial, no new safety signals emerged, affirming its status as a safe and reliable facial filler.
With these findings in hand, the FDA had what it needed to give the green light. And for practitioners, that means added peace of mind knowing that Evolysse™ fillers have gone through robust, high-standard trials before ever reaching your treatment room.
In a market where safety and performance are non-negotiable, this level of clinical rigour makes all the difference. It’s not just hype, it’s proof.
5. Safety and Efficacy: What the Data Shows
When it comes to injectable treatments, clients want results but never at the cost of safety. That’s why the Evolysse™ clinical program focused so heavily on both the efficacy and tolerability of the product line. The outcomes are reassuring for anyone considering these new fillers.
A strong safety profile
Across the studies, Evolysse™ Form and Evolysse™ Smooth demonstrated a safety profile that aligns with — and in some cases, improves upon — other market leaders. The most common side effects were:
Mild swelling
Redness at the injection site
Tenderness or bruising
Evolysse™ Form vs Evolysse™ Smooth
Feature | Evolysse™ Form | Evolysse™ Smooth |
Intended Use | Moderate to severe wrinkles, contouring | Fine lines, superficial volume loss |
Gel Texture | Firm but flexible | Soft, highly spreadable |
Injection Depth | Mid-to-deep dermis | Superficial-to-mid dermis |
Areas | Nasolabial folds, cheeks, chin, jawline | Under-eyes, perioral lines, lips |
Duration of Results | 9–12 months | 6–9 months |
All of which resolved naturally within a few days, a pattern we know and expect with hyaluronic acid injections.
Importantly, there were no serious adverse events linked directly to the product, and no reports of granuloma or vascular complications in the studied population.
High patient satisfaction
Here’s where things get exciting. Patient-reported outcomes showed:
A high satisfaction rate for the naturalness of results
Visible improvement in treated areas even months after injection
A strong preference for the soft, integrated feel of the Cold-X™ gel texture
In fact, many patients noted that their skin felt not only fuller but also healthier , likely due to HA’s natural hydration-boosting properties. This points to Evolysse™ being not just a wrinkle-filler, but a multi-dimensional skin enhancement tool.
So whether you're looking for subtle refinement or a more noticeable lift, these long-lasting dermal fillers offer predictable, pleasing results, backed by clinical science and real-world satisfaction.
6. How Evolysse™ Compares to Other HA Fillers
In a market already rich with big-name fillers like Juvéderm® and Restylane®, what makes Evolysse™ stand out? Well, let’s look at the details because that’s where the difference really shows.
Evolysse™ vs Other Market Leaders
Feature/Attribute | Evolysse™ | Juvéderm® | Restylane® |
FDA Approval Year | 2025 | 2006 (various) | 2003 (various) |
HA Production Technology | Cold-X™ Technology | Hylacross® / Vycross® | NASHA / XpresHAn® |
Injection Comfort | High | Moderate | Moderate |
Integration with Tissue | Natural and seamless | Slightly firmer feel | Moderate integration |
Duration (Average) | 9–12 months | 6–12 months | 6–10 months |
Patient Satisfaction (reported) | 90%+ | ~85% | ~85% |
Texture & Integration
Traditional fillers are often created using heat-based manufacturing, which can result in a thicker, sometimes firmer texture. Evolysse™, thanks to its Cold-X™ technology, preserves the HA’s natural softness, resulting in a silky-smooth gel that integrates more naturally into the skin. Clients love that it doesn’t feel bulky under the skin, it moves with your expressions and feels like you.
Molecular Integrity
By preserving more of the HA chains’ original structure, Evolysse™ may offer enhanced water retention and hydration benefits. This gives clients that gorgeous “bounce” to their skin that isn’t just about volume — it’s about glow.
Duration of Results
While every client metabolises fillers differently, early indications suggest Evolysse™ Form and Smooth last at least as long as their counterparts in the Restylane® and Juvéderm® families, potentially even longer, thanks to the structure-preserving tech. This means fewer maintenance appointments and a more convenient routine.
Patient Comfort
Because of its smoother consistency, patients often describe the injection experience as more comfortable, with less post-treatment swelling or tenderness. That’s a win-win for both clients and practitioners.
In essence, Evolysse™ isn’t trying to replace the classics, it’s aiming to refine what’s possible in the world of premium injectable fillers. And with Evolus’ track record of innovation, it’s positioned to do just that.
7. What This Means for Aesthetic Practitioners
As an aesthetic practitioner, choosing the right injectable dermal fillers for your clinic is essential to delivering the best possible results to your clients. With Evolysse™ Form and Evolysse™ Smooth now FDA-approved, these new fillers offer practitioners some significant advantages.
Precision and Versatility
Evolysse™ gives you the ability to treat a wide range of concerns with tailored formulations for different areas of the face. Whether you're contouring deeper structures or refining fine lines, these fillers provide you with flexibility and precision.
Evolysse™ Form: Ideal for more severe wrinkles and volume loss.
Evolysse™ Smooth: Perfect for delicate areas like under-eye circles or those fine lines around the mouth.
This versatility means you don’t need multiple products for different facial zones — simplifying your inventory and providing more consistency in your results.
Easier Injection Technique
Thanks to the smooth, natural-feeling gel and Cold-X™ technology, Evolysse™ injections tend to feel easier to manipulate. You’ll find it’s easier to inject and less likely to cause uneven results — whether you're performing subtle contouring or more advanced shaping. This can lead to faster procedure times and fewer touch-ups down the line.
Increased Client Satisfaction
For clients, the experience of receiving an Evolysse™ treatment is often described as comfortable and relatively painless. With the faster integration and less swelling, the recovery time is shorter, which is always a great selling point in consultations. When your patients feel comfortable and love the natural-looking results, you get a higher retention rate, more repeat business, and referrals — the foundation of a thriving aesthetic practice.
A Competitive Edge
Offering FDA-approved, cutting-edge fillers like Evolysse™ also positions your practice as a forward-thinking, innovative provider. By incorporating the latest technologies and staying ahead of the trends, you’re giving your clients the best possible care and ensuring your practice stays competitive in a busy market.
References
Title | URL |
FDA Approval Announcement for Evolysse™ | |
Evolus® Official Website | |
What is Hyaluronic Acid? | |
Understanding FDA Approval Process | |
Juvéderm® Filler Range | |
Restylane® Product Information |
About Me
Hi, I’m Nurse Marina, and I’m so glad you’re here! I founded Juvenology Clinic in Kent to bring a truly personalized approach to botox, dermal fillers, skincare, and overall wellness.
Before transitioning into aesthetics, I spent 6 years as a Cardiac Nurse at KIMS Hospital in Maidstone, where I developed a deep understanding of anatomy. I then honed my skills as a Specialist Aesthetics Nurse at Spencer Private Hospital in Kent.
I’m a proud member of professional organizations like JCCP, BAMAN, NMC, ACE Group, and the Royal College of Nursing. I want to make sure that every treatment I deliver is backed by the latest knowledge and techniques in medical aesthetics.