The news keep coming this month. This time in a significant advancement for aesthetic medicine, the U.S. Food and Drug Administration (FDA) has officially approved two new hyaluronic acid (HA) dermal fillers. Evolysse Form and Evolysse Smooth are used for the correction of moderate to severe nasolabial folds. They are developed by Evolus, the company already known for its neurotoxin Jeuveau (aka “Newtox”). These fillers are the first in a new Evolysse filler line to receive FDA clearance. Evolus is now a stronger competitor in a market long dominated by Allergan brands like Juvéderm and Restylane.
For context, the FDA (U.S. Food and Drug Administration) is the regulatory body responsible for protecting public health by ensuring the safety and quality of drugs, biologics, and medical devices in the United States. FDA approval is important because it signifies that a product has passed rigorous clinical trials and is deemed both effective and safe for public use. In the aesthetics space, this is a critical milestone, especially for injectables, where trust, performance and patient safety are critical for success.
The approval of Evolysse Form and Evolysse Smooth comes at a time of increased interest in targeted, non-surgical aesthetic procedures. Facial rejuvenation is specifically popular. It also follows the FDA’s recent approval of Allergan’s hybrid injectable Skinvive, a microdroplet hyaluronic acid skin booster. They also approved Revance’s RHA Redensity filler for perioral lines.
This green light for Evolus is especially noteworthy because it marks the company’s first entry into dermal fillers in the U.S. market. This is building on its successful entry into the neurotoxin space. With Evolysse Form and Smooth designed specifically for addressing nasolabial folds (the lines that run from the nose to the corners of the mouth), practitioners now have new tools tailored for a very common, age-related concern.
The introduction of these two new HA fillers supports the precision aesthetics trend. Products are created not just for general volumization, but for treating specific areas of the face with advanced formulation technology. Evolysse’s arrival also reflects the broader growth and segmentation of the dermal filler market, which is forecast to exceed $9 billion globally by 2030.
What Are Evolysse Form & Evolysse Smooth?
Evolysse Form and Evolysse Smooth are injectable hyaluronic acid gels developed by Evolus, a company renowned for its innovative aesthetic products. These fillers are engineered to provide natural-looking results, targeting the deep lines and wrinkles that form around the nose and mouth. An area commonly known as nasolabial folds.
Both fillers are designed to integrate seamlessly with the skin, offering a smooth and natural appearance. Clinical trials have shown that these fillers provide results that last up to 12 months. This is considerably longer than other temporary fillers, reducing the need (and cost) for frequent touch-ups.
This is a non-surgical option for individuals looking to enhance their facial aesthetics. An important addition to a market that is dominated by well known hyaluronic acid fillers.
| Brand Name | Description |
| Juvéderm | Smooth, HA fillers for various facial areas and concerns. |
| Restylane | Versatile HA fillers for wrinkles, volume, and lip enhancement. |
| Belotero | Smooth, cohesive HA filler for subtle to moderate lines. |
| Revanesse | HA fillers known for smooth application and natural results. |
| The RHA Collection | Resilient HA fillers designed to move with facial expressions. |
| Teosyal | Pure HA fillers with a focus on natural-looking correction. |
| Radiesse | Calcium hydroxylapatite filler, stimulates collagen. |
| Sculptra | Poly-L-lactic acid filler, stimulates collagen over time. |
| Profhilo | Ultra-pure HA for skin hydration and bio-remodeling (not just filling). |
| Revolax | Monophasic HA fillers with high viscoelasticity. |
Why This Approval Matters
The FDA’s approval of Evolysse Form and Evolysse Smooth is a testament to the growing demand for effective and safe aesthetic treatments. Nasolabial folds are a common concern among individuals seeking facial rejuvenation, and these fillers provide a targeted solution that addresses this specific issue.
For aesthetic practitioners, the introduction of these hyaluronic acid fillers expands the range of tools available for personalized treatment plans. For consumers, it offers a new option to achieve youthful, radiant skin with minimal downtime.
Aesthetic medicine continues to grow and evolve. The approval of innovative products like Evolysse Form and Evolysse Smooth is another important milestone for the industry. These news encourage innovators to keep working towards safer and more effective solutions. Making us prettier with less hassle.
