FDA Approves Juvéderm Volbella XC for Undereye Hollows

Allergan Aesthetics, an AbbVie company, announced that the FDA has approved Juvéderm Volbella XC for infraorbital hollow improvement for patients over the age of 21. The clinical trial (NCT03418545) found that 90% of patients reported satisfaction through 1 year after receiving treatment. The FDA requires that Allergan Aesthetics provide a product training program for all interested providers, which will include facial anatomy and considerations for safe injections in this area, as well as how to identify and manage potential complications of treatment. This training must be completed successfully before use of Juvéderm Volbella XC in 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," said 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."

As the Juvéderm collection of fillers continues to grow, Allergan Aesthetics will continue to train providers through the Allergan Medical Institute (AMI). The press release states, “During the required infraorbital hollows training, providers will be educated on how to assess facial anatomy holistically where for Juvéderm Volbella XC may be added as part of a treatment plan to address volume loss in the midface.” They also noted that the safety and efficacy of combined use for Juvéderm Voluma XC and for 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. This is in part because it is a sensitive area to inject as it takes great skill and precision," said AMI trainer, board-certified oculofacial plastic surgeon and ophthalmologist, Julie Woodward, MD, Durham, North Carolina.

“The characteristics of Juvéderm Volbella XC with lower amounts of hyaluronic acid (HA) 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.” She continued to explain that 80% of subjects in the clinical trial 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.

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<.0001) than the responder rate for the no–treatment control group (15.6%) based on the mITT population with multiple imputation, the press released explained. There was clinically significant improvement in the mean of patients (≥1 point), with the majority of patients demonstrating improvement through 1-year.

The most common adverse events (AEs) among patients were tenderness to touch, bruising, swelling, lumps/bumps, redness, pain after injection, firmness, discoloration (not redness or swelling), or itching. Most of these AEs were mild in severity, although a few patients 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 AEs resolved within 45 days.

Reference:

1. FDA approves Juvéderm VolbellaXC for undereye hollows.AbbVieNews Center. Published February 8, 2022. Accessed February 8, 2022. https://news.abbvie.com/news/press-releases/fda-approves-juvderm-volbella-xc-for-undereye-hollows.htm?view_id=6943