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Galderma Receives FDA Approval for Sculptra for Cheek Wrinkles

By The Aesthetic GUIDE posted May 04, 2023 11:02 PM

Galderma announced today that the U.S. Food and Drug Administration (FDA) has approved Sculptra® (injectable poly-L-lactic acid (PLLA-SCA)) for the correction of fine lines and wrinkles in the cheek area.
Sculptra is the first and original FDA-approved PLLA collagen stimulator that, when injected into the cheek area, helps stimulate natural collagen production to smooth wrinkles and improve skin quality such as firmness and glow, with results lasting up to 2 years.
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.
"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,1 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."

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