FDA approves Juvderm Volbella XC for undereye hollows.

According to clinical trial data, 90% of subjects reported satisfaction through one year after treatment. With this approval, Allergan Aesthetics continues the expansion of its treatment portfolio to better address unmet patient needs. Per FDA requirement for this new indication, Allergan Aesthetics is providing a product training program for all interested providers, which includes facial anatomy and considerations for safe injection in this area, as well as identification and management of potential complications. Successful completion of this training is necessary prior to administration of Juvederm Volbella XC for this new indication".

"The undereye area is one of the most frequently requested treatment sites among patients, regardless of race and ethnicity, but it is undertreated. This is in part because it is a sensitive area to inject as it takes great skill and precision," says AMI trainer, Board Certified Oculofacial Plastic Surgeon and Ophthalmologist, Dr. Julie Woodward. "The approval of Juvderm Volbella XC is a milestone in offering providers, like myself, a safe and effective treatment option to address the undereye area for my patients. The characteristics of Juvderm Volbella XC with lower amounts of hyaluronic acid molecules and low water affinity provides a soft, smooth formulation appropriate for treating undereye hollows and I am excited to work with Allergan Aesthetics on a robust injector and patient education plan to ensure safe and effective outcomes in this challenging to treat area. The results of the clinical trial demonstrate significant improvements in the appearance of undereye hollows and overall appearance. In addition, 80% of subjects reported they were a little or not at all bothered by how tired and old the under-eye area looked at 3 months compared to 15% and 30% before treatment, respectively."