FDA Approves Injectable Poly-L-Lactic Acid to Correct Smile Wrinkles

Yael Waknine

July 30, 2009

July 30, 2009 — The US Food and Drug Administration (FDA) has approved injectable poly-L-lactic acid (Sculptra Aesthetic, sanofi-aventis US) for use in immune-competent people to correct shallow to deep nasolabial fold contour deficiencies ("smile wrinkles") and other facial wrinkles in which deep dermal grid pattern (cross-hatch) injection technique is appropriate.

The approval was based on data from a randomized, comparative, evaluator-blinded, parallel-group, multicenter study (n = 233) showing that use of the product yielded greater improvements in wrinkle correction at 13 months compared with human-derived collagen, as determined by wrinkle assessment scores.

"Sculptra Aesthetic showed effective correction of the nasolabial folds, which are considered to be the hallmark signs of facial aging," said Paul Chew, MD, chief science officer/chief medical officer, sanofi-aventis US, in a company news release.

During the extension-phase study, patients initially treated with injectable poly-L-lactic acid continued to demonstrate gradual improvements in wrinkle assessment scores; benefits were maintained for up to 25 months after completion of therapy compared with 3 months for patients treated with human-derived collagen.

Injectable poly-L-lactic acid is administered as a single treatment regimen of up to 4 sessions at 3-week intervals. It should not be used in patients with hypersensitivity to product components or in those with known history of or susceptibility to keloid formation or hypertrophic scarring.

Commonly reported short-term injection site reactions included bleeding, tenderness or pain/discomfort, erythema, bruising, pruritis, or inflammation. Other adverse events reported in the 25-month study included small bumps and lumps of mild to moderate intensity, some with delayed onset. The majority of events were self-limiting; 1 small lump required treatment by the healthcare provider.

Injectable poly-L-lactic acid previously was approved by the FDA for the restoration and/or correction of lipoatrophy in patients with HIV-1 infection.