Galderma announces the new label for SCULPTRA (injectable poly-L-lactic acid (PLLA)), the first and only FDA-approved PLLA facial injectable treatment that helps stimulate the skin’s own collagen production, to smooth facial wrinkles, such as smile lines.
The new label approved by the US Food and Drug Administration (FDA) includes higher dilution, the addition of immediate use reconstitution, new injection techniques and the optional addition of lidocaine. These changes provide aesthetic injectors with even more options to administer SCULPTRA safely and effectively.
SCULPTRA delivers gradual, natural-looking results over an average of 3 treatments spaced at least 3 weeks apart. In a clinical study, 100% of patients still showed improvement in the appearance of wrinkles up to 2 years after last treatment according to investigator evaluation.
The new label approval is based on new data from physiochemical studies, as well as results from a randomized, evaluator-blinded, parallel-group, multi-center study evaluating the safety and effectiveness of two different dilutions of SCULPTRA. This study demonstrated 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.
“Galderma is committed to driving innovation in aesthetics, and the new label for SCULPTRA is just one example of how we continue to invest in our portfolio to ensure our healthcare partners have the products they need. SCULPTRA is an important part of Galderma’s collection of aesthetic treatments in the U.S., and this new label will allow us to improve the overall injector and patient experience. Interest in biostimulators is growing, and we are committed to continuing our legacy of training and education, focused on safety and outcomes as a part of our overall commitment to the aesthetic industry.”— Diane Gomez-Thinnes, Head of Galderma U.S.
Through the Galderma Aesthetic Injector Network (GAIN) training and education platform, aesthetic partners will learn about the new label, train on injection technique, and share best practices for incorporating SCULPTRA into their aesthetic offering.
[Source(s): Galderma, PR Newswire]