04.26.23
Galderma announced that the U.S. Food and Drug Administration (FDA) has approved its collagen stimulator Sculptra for a new benefit—cheek wrinkles.
Sculptra, an injectable poly-L-lactic acid (PLLA-SCA), is now FDA-approved for injecting into the cheek area to address fine lines and wrinkles. Sculptra helps stimulate natural collagen production to smooth wrinkles and improve skin quality such as firmness and glow, with results lasting up to 2 years, Galderma reports.
Sculptra achieved its primary efficacy endpoint of ≥1-grade improvement in cheek wrinkles at rest and its secondary endpoint of addressing cheek wrinkles when smiling for up to 2 years.
Bill Andriopoulos, PH.D., U.S. Vice President of Medical Affairs at Galderma, comments:
"The long-standing science, safety and efficacy behind Sculptra makes this FDA approval a meaningful milestone for Galderma. With 95% of patients still showing improved skin glow two years after treatment when injected into the cheek region, we recognize how much of an impact biostimulators can have on the aging face. This new indication allows for Sculptra to pave the way as a leader in the PLLA collagen stimulator category, and we are excited to see what the future holds for this innovative product."
This FDA approval is supported by efficacy and safety data from a randomized, evaluator-blinded, no-treatment controlled, multicenter study to evaluate the effectiveness and safety of Sculptra for correction of cheek wrinkles.
