FDA Approves Evolysse™ Form and Smooth, Expanding Aesthetic Options
Evolus, Inc., a performance beauty company focused on building an aesthetic portfolio, has announced a significant milestone in its growth strategy. The U.S. Food and Drug Administration (FDA) has given its stamp of approval to Evolysse™ Form and Evolysse™ Smooth, two injectable hyaluronic acid (HA) gels that mark the company’s entry into the U.S. HA dermal filler market. This approval not only solidifies Evolus’ position as a multi-product innovator in aesthetics but also expands its total addressable market by a substantial 78%, reaching approximately $6 billion.
David Moatazedi, President and CEO of Evolus, expressed enthusiasm about this development, stating, “This milestone represents an exciting new chapter in our long-term strategy to expand our portfolio and transition from a single-product company to a multi-product innovator, strengthening our leadership in performance beauty.” He further emphasized that Evolysse™ Form and Evolysse™ Smooth represent the first major technological breakthrough in HA dermal fillers in a decade, setting a new standard in performance and innovation.
The company plans to launch these products in the U.S. market in Q2 2025, leveraging its existing cash-pay business model and digital infrastructure. This launch is expected to create synergy with Evolus’ growing neurotoxin business and drive significant value for both customers and consumers.
The Evolysse™ collection, designed by Symatese, utilizes innovative Cold-X™ technology, which is designed to better preserve the natural structure of the HA molecule for long-lasting, natural-looking results. Jean-Paul Gérardin, CEO of Symatese, highlighted the extensive clinical trial program undertaken for this injectable HA technology, involving over 2,000 patients globally.
Dr. Rui Avelar, Evolus Chief Medical Officer and Head of R&D, emphasized the company’s commitment to bringing high-quality, innovative aesthetic products to market. He noted that the introduction of Cold-X™ technology offers a differentiated approach to the dermal filler category.
The U.S. Nasolabial Fold (NLF) pivotal study for Evolysse™ Form and Evolysse™ Smooth included 140 patients in a double-blind, prospective, randomized, active-control split-face trial. Both products met the primary endpoint of non-inferiority and demonstrated statistical superiority when compared to Restylane®-L.
Dr. Michael Kaminer, lead investigator for the U.S. NLF pivotal study, commented on the impressive safety, efficacy, and versatility of the Evolysse™ Form and Evolysse™ Smooth injectable HA gels. He noted their unique property of being injectable at various depths in the skin, allowing practitioners to achieve precise, natural-looking results with high patient satisfaction.
Evolus has also received EU Medical Device Regulation (MDR) approval for four unique injectable hyaluronic acid (HA) gels under the brand name Estyme®. The company is introducing Estyme® through a limited experience program with select physician partners in Europe, with a broader European launch planned for the second half of 2025.
Commentary by SuppBase columnist Alice Winters
The entry of Evolus into the hyaluronic acid dermal filler market with their Evolysse™ line marks a significant development in the aesthetic industry. This move not only diversifies Evolus’ product portfolio but also introduces a potentially game-changing technology to a market that has seen little innovation in the past decade.
The Cold-X™ technology employed in the Evolysse™ line is particularly intriguing. By better preserving the natural structure of the HA molecule, this technology could potentially offer longer-lasting and more natural-looking results. This could be a major selling point for both practitioners and patients who are always seeking treatments that offer optimal outcomes with minimal downtime.
However, it’s important to note that while the clinical trials show promising results, the true test will come when these products are widely used in real-world settings. The aesthetic market is highly competitive, and patient satisfaction is paramount. The success of Evolysse™ will depend not only on its clinical efficacy but also on factors such as ease of use for practitioners, patient comfort during and after treatment, and the longevity of results.
The fact that Evolysse™ Form showed statistically significant differences compared to Restylane-L at all measured timepoints for the entire 12-month study period is impressive. This could potentially translate to fewer touch-up treatments for patients, which would be a significant advantage in terms of both convenience and cost-effectiveness.
From a market perspective, Evolus’ expansion into the HA dermal filler space is a smart move. With this approval, they’ve significantly increased their total addressable market. This diversification could provide more stable revenue streams and potentially accelerate the company’s growth.
The planned European launch of Estyme® further demonstrates Evolus’ commitment to global expansion. This could help the company capture a larger share of the international aesthetic market, which is growing rapidly, especially in regions like Asia and Europe.
However, it’s worth noting that entering the HA filler market puts Evolus in direct competition with well-established players like Allergan (now part of AbbVie) and Galderma. These companies have strong brand recognition and loyal customer bases. Evolus will need to leverage its innovative technology and potentially competitive pricing to carve out its share of the market.
In conclusion, the approval of Evolysse™ Form and Evolysse™ Smooth represents a significant milestone for Evolus and potentially for the dermal filler market as a whole. If the products live up to their clinical trial results in real-world use, they could indeed set a new standard in the industry. However, as with any new product in the aesthetic space, long-term safety data and real-world results will be crucial in determining their ultimate success and impact on the market.
