FDA approves Sculptra for cheek wrinkles

Key takeaways:

• Sculptra is the first and original injectable poly-L-lactic acid approved for the correction of cheek wrinkles.
• 94% of patients saw improvement for up to 2 years.

The FDA has approved Sculptra, an injectable poly-L-lactic acid, for the correction of cheek wrinkles, Galderma announced in a press release.

Sculptra injectable poly-L-lactic acid (PLLA) was first approved in 2004 for the correction of facial lipoatrophy and facial wrinkles. According to the release, it is the original FDA-approved PLLA collagen stimulator that helps in the production of natural collagen and maintains improved smoothness, firmness and glow up for up to 2 years.

"The long-standing science, safety and efficacy behind Sculptra makes this FDA approval a meaningful milestone for Galderma,” Bill Andriopoulos, PhD, U.S. vice president of medical affairs at Galderma, said in the release.

Data from a randomized, multicenter clinical study were used to support the approval of Sculptra in this indication. Results from the study showed that 96% of patients showed improvement at 3 months, whereas 94% showed improvement at both 1 and 2 years.

“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,” Andriopoulos said.