The U.S. Food and Drug Administration (FDA) has approved Sculptra®, Galderma’s injectable poly-L-lactic acid (PLLA-SCA), to correct fine lines and wrinkles in the cheek area.
Sculptra is the first FDA-approved PLLA collagen stimulator that smooths wrinkles and improves the firmness and glow of the cheeks, with results lasting up to 2 years. It was first approved for aesthetic use in the U.S. in 2009 to correct nasolabial folds and other facial wrinkles.
According to studies conducted, patients showed sustained aesthetic improvement in cheek wrinkles, with 96% showing improvement at 3 months, 94% at 1 year, and 94% at 2 years. Researchers concluded that the primary endpoint of ≥1-grade improvement in cheek wrinkles at rest was achieved. The secondary endpoint of addressing cheek wrinkles when smiling for up to 2 years was also reached.
The most common adverse events recorded were swelling at the injection site, tenderness, redness, pain, bruising, bleeding, itching, and lumps. Other adverse reactions included lumps under the skin, some with delayed onset with or without inflammation or skin discoloration. Galderma has however warned that PLLA-SCA should not be given to patients with a history of keloid formation or hypertrophic scarring.
"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."
