The Company is seeking approval for the treatment to temporarily improve the appearance of moderate to severe glabellar lines.
The approval was based on a multicenter, randomized, evaluator-blinded, split-hand study (N=89) which showed that treatment with Restylane Lyft resulted in a clinically meaningful improvement in the correction of volume deficits of treated hands for up to 6 months.
Silicone injections for body contouring are often performed by unlicensed and non-medical practitioners in non-clinical settings such as residential homes or hotels.
Botox Cosmetic is already approved for the temporary improvement of crow's feet lines and frown lines between the eyebrows in adults.
The FDA approval was based on data from a Phase 3, multi-center, prospective, double-blind, randomized, placebo-controlled study in 381 adults treated with Dysport 1000 Units, Dysport 1500 Units or placebo after a stroke or traumatic brain injury.
The injectable gel is balanced with firmness and low cohesivity delivering results that last up to 18 months from the initial or touch-up injection.
Galderma announced that the Food and Drug Administration (FDA) approved 2 new dermal fillers for the treatment of nasolabial folds (NLF), also known as "laugh lines," in patients aged >21 years old.