Galderma's Sculptra Now FDA Approved for Cheek Wrinkles

Sculptra is the first FDA-approved PLLA collagen stimulator that helps stimulate natural collagen production in the cheeks with results lasting up to 2 years.

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 FDA-approved PLLA collagen stimulator that helps stimulate natural collagen production in the cheeks with results lasting up to 2 years.

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.

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 two years.

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. 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," says Sabrina Fabi, MD, a dermatologist 
in San Diego, Calif. and an investigator in clinical trials of Sculptra for cheek wrinkle treatments.

*≥1-grade improvement on the Galderma Cheek Wrinkles Scale (GCWS; At rest and Dynamic)
†Patients = clinical trial participants
‡Rating of 'improved' or better on the Global Aesthetic Improvement Scale (GAIS)