The FDA recently approved a new label for Galderma’s popular injectable Sculptra. According to experts, the increased availability of the collagen biostimulator is a game-changer. Per a statement, the new label includes “higher dilution, the addition of immediate use reconstitution, new injection techniques and the optional addition of lidocaine.” These changes expand the possibilities for professionals administering the injectable.
Sculptra is made of poly-L-lactic acid, which stimulates collagen within the skin to treat and correct facial wrinkles and folds. According to the statement, studies 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 (Sculptra 5 mL) in reducing wrinkle severity of nasolabial folds (NLF) at Week 48.”
“Sculptra has always been a remarkable product to stimulate a patient’s own natural collagen for volume and improve skin quality and texture,” says San Francisco, CA facial plastic surgeon David W. Kim. “[I am] excited about this new indication of immediate use after reconstitution.”
Diane Gomez-Thinnes, head of Galderma U.S., said the new label will allow the company “to improve the overall injector and patient experience.” According to the statement, Sculptra provides gradual, natural-looking results over the course of about three treatments three weeks apart. The statement cited a study that found 100-percent of patients showed improvement in the appearance of wrinkles up to two years after their last treatment.
