The US Food and Drug Administration has given its nod to Allergan Aesthetics, Juvederm Volbella XC  for improvement of infraorbital hollows in adults over the age of 21.

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.

"This additional indication for Juvederm 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, in a news release. 

During the required infraorbital hollows training through the Allergan Medical Institute (AMI)., providers will be educated on how to assess facial anatomy holistically where Juvederm Volbella XC may be added as part of a treatment plan to address volume loss in the midface. The safety and efficacy of combined use Juvederm Volbella XC and Juvederm 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. This is in part because it is a sensitive area to inject as it takes great skill and precision," says AMI trainer and oculofacial plastic surgeon and ophthalmologist Dr. Julie Woodward. "The approval of Juvederm 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 Juvederm 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 percent and 30 [ercent before treatment, respectively."

According to the clinical studies, the primary effectiveness criteria were met in the treatment group's responder rate of 83.1 percent and was statistically significantly greater (p<0.0001) than the responder rate for the no–treatment control group (15.6%) based on the mITT population with multiple imputation. The mean improvement was clinically significant (≥ 1 point), with the majority of subjects demonstrating improvement through one year. In addition, 90.1 percent of patients were willing to recommend the treatment to a friend.

The majority of subjects in the clinical study experienced a side effect, such as tenderness to touch, bruising, swelling, lumps/bumps, redness, pain after injection, firmness, discoloration (not redness or swelling), or itching as reported in their 30-day daily diaries. A majority of these side effects were mild (easily tolerated) in severity, although a few subjects experienced mild swelling more than 30 days after treatment. The swelling was treated with antibiotics for 1 subject; the other subjects did not require treatment. All of these events resolved within 45 days.

Juvederm Volbella XC was first FDA–approved in 2016 for use in the lips and perioral rhytids.