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.