FDA approves first major brand filler for upper face

Juvederm filler model Juvéderm Voluma XC Allergan Aesthetics' filler products have been approved by the US Food and Drug Administration (FDA) for the correction of moderate to severe nasolabial folds in adults 21 years of age and older.

The approval followed positive clinical study data, in which the majority of patients who received the filler reported overall satisfaction with their treatment. In this randomized controlled study, 112 patients were assigned to a treatment group and received injections in the temporal region, while 58 patients were assigned to a no-treatment control group.

Efficacy has been proven in clinical studies.

  • Most patients reported overall satisfaction with their treatment.
  • 59% patients reported a clear outcome (TSR). 70.5% patients reported that those outcomes were mild or moderate.
  • Patient 60% reported that all results disappeared within 3 days.
  • More than 80% patients reported at least 1-grade improvement in nasolabial fold severity after 3 months of treatment.
  • Results lasted for more than 1 year in 73% patients.
  • More than 85% patients reported satisfaction with their facial appearance 3 months after treatment.

Allergan Aesthetics is committed to developing the skills of professionals.

  • Launch of Juvéderm Voluma XC product training program for beauty and skin care providers
  • Covers facial anatomy, patient use, safe injections, and management of complications.

Dr. Deirdre Hooper, Dermatologist and AMI Trainer “She is excited to begin training injectors on how to use Juvéderm Voluma XC to help address moderate to severe nasolabial folds,” she said.

  • Patients reported looking approximately five years younger after six months of Juvéderm Voluma XC treatment.
  • More than 85% clinical study participants were satisfied with their treatment and would recommend it to their friends.

Juvéderm Voluma XC is also indicated for deep injections for cheek augmentation (correcting age-related loss of volume in the midface) and for chin augmentation (correcting the chinline, giving the face balance and shape).

Thanks for the information from : FDA Approves Juvederm as the First and Only Hyaluronic Acid Dermal Filler for Use in Moderate to Severe Temple Hollowing (dermatologytimes.com)