The majority of study participants demonstrated improvement of infraorbital hollows through 1 year.
The FDA has approved Juvederm Volbella XC for improvement of infraorbital hollows in adults 21 years of age or older, according to a press release from AbbVie.
Juvederm Volbella is an injectable gel indicated for injection into the lips for lip augmentation and correction of perioral rhytids, in addition to the new indication for undereye hollows. It was first approved for lip augmentation in 2016, according to the press release.
The FDA approval requires a product training program for all providers interested in administering the treatment. The program includes facial anatomy and considerations for safe injections in the face, as well as identification and management of potential complications. Successfully completing the training is necessary prior to administration of Juvederm Volbella XC for the 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,” said Julie Woodward, MD, a trainer with Allergan Medical Institute, in the press release. “This is in part because it is a sensitive area to inject as it takes great skill and precision.”
According to the clinical studies, the primary efficacy criteria were met in the treatment group’s responder rate of 83.1% and was statistically greater than the responder rate for the control group. The mean improvement was clinically significant, and the majority of subjects demonstrated improvement through 1 year. Furthermore, 90.1% of patients were willing to recommend the treatment to a friend, according to the press release.
“The results of the clinical trial demonstrate significant improvements in the appearance of undereye hollows and overall appearance,” Woodward said in the press release. “In addition, 80% of subjects reported they were a little or not at all bothered by how tired and old the undereye area looked at 3 months compared to 15% and 30% before treatment, respectively.”
Most patients in the study experienced an adverse effect (AE), such as tenderness to touch, bruising, swelling, lumps or bumps in the injection area, redness, pain after injection, firmness, discoloration, or itching. Most AEs were mild and easily tolerated, although a few subjects experienced mild swelling more than 30 days after treatment, according to the press release. The swelling was treated with antibiotics for 1 subject, and others did not require treatment. All of these events resolved within 45 days.
“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,” Woodward said in the press release. “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.”
FDA Approves Juvederm Volbella XC for Undereye Hollows. News release. AbbVie; 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=5795