Allergan Aesthetics, an AbbVie company, announces the FDA approval of JUVÉDERM VOLBELLA XC for improvement of infraorbital hollows in adults over the age of 21. 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 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. 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.”— Carrie Strom, President, Global Allergan Aesthetics and Senior Vice President, AbbVie
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. This is in part because it is a sensitive area to inject as it takes great skill and precision. 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.”— AMI trainer, Board Certified Oculofacial Plastic Surgeon and Ophthalmologist, Dr. Julie Woodward
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<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% of patients were willing to recommend the treatment to a friend.
Consumers and new patients who receive aesthetic treatment from the JUVÉDERM Collection of Fillers, can also enroll in Allē, Allergan Aesthetics loyalty rewards program to unlock access to curated content, exclusive offers, and personalized rewards that can be used for savings on the Allergan Aesthetics portfolio of products and redeemed at a participating provider’s office, subject to program terms and conditions that apply. Allē is the first and only loyalty program in the aesthetics market to also offer consumers the ability to earn points on over 40 non-Allergan Aesthetics treatments and brands.
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.
JUVÉDERM VOLBELLA XC was first FDA–approved in 2016 for use in the lips and perioral rhytids. As the category leader, the JUVÉDERM Collection of Fillers offers the broadest portfolio of specifically tailored treatment options, and this latest approval marks the sixth approved indication in the US.
[Source(s): AbbVie, PR Newswire]