Allergan’s gel derma filler receives FDA approvalNovember 15, 2019
Allergan has received US FDA approval for the use of Juvéderm Voluma XC, a hyaluronic acid gel dermal filler, with a TSK Steriglide cannula for cheek augmentation to correct age-related volume deficit in the mid-face in adults over 21.
A multicentre, split-face, investigator-blinded, non-inferiority study was performed to assess the safety and effectiveness of Juvéderm Voluma XC for correction of age-related volume deficit in the mid-face with the use of a TSK Steriglide cannula versus a needle. The 12-week study took place in seven sites across the US with 60 subjects. All subjects completed the study. Results demonstrated comparable performance, safety profile and patient satisfaction between cannula and needle injection.
Juvéderm Voluma XC was first approved by the FDA in 2013 which blends different molecular weights of hyaluronic acid, contributing to the gel’s duration and is proven to last in the mid-face area for up to 24 months with optimal treatment.