FDA approves two hyaluronic acid fillers for nasolabial folds
Key takeaways:
- Evolysse Form and Evolysse Smooth were developed using Cold-X technology from Symatese.
- The approval was based on results from a split-face trial comparing the two products with Restylane-L.
The FDA has approved Evolysse Form and Evolysse Smooth injectable hyaluronic acid gels, two dermal fillers from Evolus, the company announced in a press release.
Both products are approved for use in the nasolabial fold region of the face and were developed by Symatese using Cold-X technology, which was designed to preserve the natural hyaluronic acid (HA) molecule, according to a press release.
“Mother Nature invented HA and it’s an amazing structure. And what Symatese, our partner, figured out was how to do the cross-linking step and do a better job of preserving Mother Nature’s work,” Rui Avelar, MD, chief medical officer and head of research and development for Evolus, told Healio.
The approval was based on results from a double-blind, prospective, randomized, active-control, split-face trial that compared Evolysse Form and Evolysse Smooth with Restylane-L (Galderma). Evolysse Form was determined to show statistically significant differences to Restylane-L for the trial’s full 12-month duration, determined by live, blinded investigators.
“The primary endpoint hit both noninferiority and it actually hit superiority,” Avelar said. “And then if you look at the treatment over time, this time with a bigger sample size ... we had more correction and it hit statistical significance at every data point, all the way until 12 months.”
The second product, Evolysse Smooth, showed statistically significant differences at 6 and 9 months, while using approximately 20% less product than the control.
The company plans to launch both products in the United States during the second quarter of 2025.
“There’s a big theme to anchor into natural products and natural outcomes. I think this falls in thematically pretty nicely,” Avelar said. “We are coming to market and hopefully providing more opportunities and more choices for our patients here in the U.S. and for our providers.”
Perspective
Back to Top
The FDA has approved Evolysse Form and Evolysse Smooth injectable HA gels, representing the entry of the aesthetics company Evolus into the U.S. HA dermal filler market.
Evolus entered into a distribution agreement with Symatese to be the exclusive distributor of its collection of HA fillers. Its patented preparation method is based on a step for crosslinking HA in the presence of a crosslinking agent, namely 1,4-butanediol diglycidyl ether (BDDE), carried out at a temperature of more than 0°C and less than 10°C. In contrast, prior patented procedures describe conducting cross-linking of HA at higher temperatures ranging from 10°C to 60°C, the majority of at maximum temperature of 45°C to 50°C.
Evolus reports that the clinical outcomes of the Symatese filler are noninferior or superior to the gold standard, Restylane-L, according to the pivotal clinical trial results. Evolus and Symatese claim their method of cross-linking at lower temperatures reduces degradation of the HA chains, resulting in decreased fragmentation and less BDDE required. While they state that the favorable clinical outcomes are due to the novel cross-linking procedure and preservation of the HA structure, data supporting these claims were not presented.
Collapse
Read more about