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IRVINE, Calif., Feb. 8, 2022 /PRNewswire/ -- Allergan Aesthetics, an AbbVie company (NYSE: ABBV), announces the FDA approval of JUVÉDERM® VOLBELLA® XC for improvement of infraorbital hollows in adults over the age of 21.2 According to clinical trial data, 90% of subjects reported satisfaction through one year after treatment.2 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 JUVÉDERM® VOLBELLA® XC for this new indication.
"This additional indication for JUVÉDERM® VOLBELLA® XC demonstrates Allergan Aesthetics' continued commitment to innovation. The eye area, including the undereye hollow, is a top concern among patients," says Carrie Strom, President, Global Allergan Aesthetics and Senior Vice President, AbbVie. "Allergan Aesthetics offers the broadest portfolio of treatment options designed to address the delicate eye area from topical skin care with SkinMedica®, to crow's feet lines with BOTOX® Cosmetic (onabotulinumtoxinA) and now, with this approval, the infraorbital hollows, commonly referred to as tear troughs, with JUVÉDERM® VOLBELLA® XC."
Patient safety and consumer satisfaction are a top priority at Allergan Aesthetics. As the JUVÉDERM® Collection of Fillers continues to be at the forefront of innovation, Allergan Aesthetics is committed to providing best-in-class training to our providers through the Allergan Medical Institute (AMI). During the required infraorbital hollows training, providers will be educated on how to assess facial anatomy holistically where JUVÉDERM® VOLUMA® XC may be added as part of a treatment plan to address volume loss in the midface. The safety and efficacy of combined use of JUVÉDERM® VOLUMA® XC and JUVÉDERM® VOLBELLA® XC has not been studied. The required training can be accessed and completed at VolbellaTraining.com.
"The undereye area is one of the most frequently requested treatment sites among patients, regardless of race and ethnicity, but it is undertreated.3 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 JUVÉDERM® 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 JUVÉDERM® 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.2"
According to the clinical studies, the primary effectiveness criteria were met in the treatment group's responder rate of 83.1% and was statistically significantly greater (p
