The U.S. Food and Drug Administration (FDA) approved a new label for Galderma’s Sculptra (an injectable poly-L-lactic acid-PLLA), the only FDA-approved PLLA facial injectable treatment that helps stimulate the skin’s own collagen production and smooth facial wrinkles like smile lines. Sculptra delivers gradual, results over an average of three treatments spaced at least three weeks apart. The new label includes higher dilution, the addition of immediate use reconstitution, new injection techniques, and the optional addition of lidocaine for patient comfort.
The new label approval is based on new data from physiochemical studies, as well as results from a study evaluating the safety and effectiveness of two different dilutions of Sculptra. This study found that treatment immediately following reconstitution with a higher reconstitution volume (9 mL including lidocaine) was well tolerated, caused less pain and was comparable to that of the reference group (Sculptra5 mL) in reducing wrinkle severity of nasolabial folds (NLF) at Week 48 (n=80) as observed by both Investigator and Blinded Evaluators.
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