Galderma said today that it won FDA approval for 2 of its products to treat nasolabial folds, or “laugh lines”. The Fort Worth, Texas-based company’s Restylane Refyne and Restylane Defyne are made with XpresHAn technology to manufacture injectable gels with customized hyaluronic acid crosslinking in each product.
The federal watchdog’s approval was based on 2 pivotal phase III trials investigating the gels for safety and efficacy. 171 participants used Restylane Refyne and 162 participants were treated with Restylane Defyne. Study investigators and participants reported an improvement in wrinkle severity after 6 weeks of using either Restylane Refyne or Restylane Defyne and both products demonstrated clinically meaningful improvement in wrinkle severity for up to 12 months.
“Even with current approved options, many of my patients are still looking for different solutions to treat their laugh lines,” clinical investigator Dr. Steven Fagien said in prepared remarks. “These new products are flexible and are designed to meet different patient needs. I am excited to offer these next-generation hyaluronic acid (HA) dermal fillers in my practice.”
After treatment with the injectable gels, the participants reported mild and temporary injection site responses such as redness, swelling and bruising. The company is conducting 3 phase IV clinical trials to evaluate the products’ effects over time.
“Restylane Refyne and Restylane Defyne are the latest FDA-approved advancements in HA dermal fillers and align with Galderma’s mission to help individuals achieve natural-looking results through treatments with a long-standing history of proven safety and efficacy,” VP & general manager of U.S. aesthetic & corrective business Kelly Huang said. “We saw an opportunity to address a common concern for patients who have not yet tried a dermal filler by designing gels that provide natural-looking results. With these new brands, the Restylane family of products now represents the broadest offering of HA dermal fillers in the U.S.”
“Many of my patients are interested to learn about the latest products that can help them achieve natural-looking results, but are oftentimes unsure about starting dermal fillers,” dermatologist Dr. Mitch Goldman added. “The introduction of these next-generation HA dermal fillers with XpresHAn technology has the potential to change my patients’ views on fillers. Restylane Refyne and Restylane Defyne provide options for patients who want to make sure they can achieve natural-looking results, which is a key need my patients express every day.”