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,” said Bill Andriopoulos, PhD, U.S. vice president of medical affairs at 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."

Patients showed sustained aesthetic improvement in cheek wrinkles throughout the study with 96% showing improvement at 3 months, 94% showing improvement at 1 year and 94% showing improvement at 2 years.

"Sculptra is a foundational treatment that helps smooth wrinkles and offers the added benefit of improved skin quality – helping to firm sagging skin for a more radiant and glowing appearance,” said Sabrina Fabi, MD, who served as an investigator in clinical trials of Sculptra for cheek wrinkle treatments. “My patients will be extremely pleased that they can now receive Sculptra in the broader cheek region to support collagen growth and to make their skin look more refreshed and rejuvenated."

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.

To learn more about Sculptra, visit www.SculptraUSA.com and follow the conversation on Instagram at @SculptraUSA.

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