The US Food and Drug Administration (FDA) has approved two new dermal fillers to improve the appearance of nasolabial fold (NLF) wrinkles in adults, the manufacturer Galderma has announced. Restylane Refyne was approved for the treatment of moderate to severe facial wrinkles and folds and Restylane Defyne, for the treatment of moderate to severe, deep facial wrinkles and folds. These “next-generation” dermal fillers are manufactured with XpresHAn Technology which creates a smooth, injectable gel that provides natural-looking results, the company explains in a news release. “XpresHAn Technology customizes the degree of hyaluronic acid (HA) crosslinking in each product, resulting in gels with a range of flexibility and support characteristics for different patient needs,” they note. The safety and effectiveness of Restylane Refyne and Restylane Defyne were each evaluated in double-blinded, randomized, active-controlled phase 3 studies involving 171 and 162 participants respectively. In both studies, Restylane Refyne and Restylane Defyne met the studies endpoints, with both products showing a clinically meaningful improvement in wrinkle severity for up to 12 months in most patients, the company reports. The studies used the Wrinkle Severity Rating Scale (WSRS), a validated 5-point measure of the size and depth of the wrinkles with grade 1 defined as absence of wrinkles and grade 5 as extremely deep and long wrinkles. After 6 weeks, 79% of Restylane Refyne recipients and 77% of Restylane Defyne recipients experienced at least a 1-grade improvement on the WSRS. “Subjects also performed self-assessments (SSA) of wrinkle severity, with most subjects reporting at least a 1-grade improvement in SSA scores with Restylane Refyne and with Restylane Defyne after 6 weeks,” the company notes. Injection site responses (redness, swelling, bruising, lump/bump formation, pain/tenderness) were mostly mild or moderate in intensity, temporary (typically lasting 1 to 2 weeks), and similar for the Restylane products. Galderma is now conducting three ongoing phase 4 clinical studies to further investigate the effects of Restylane Refyne and Restylane Defyne.

Source: MedScape