FDA Approves Juvéderm Volbella XC For Undereye Hollows
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<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.5 In addition, 90.1% of patients were willing to recommend the treatment to a friend.5
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.4
Juvéderm® Volbella® XC was first FDA–approved in 2016 for use in the lips and perioral rhytids.2 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 U.S.
For more information on the Juvéderm® Collection of Fillers, visit Juvéderm.com and follow @JUVÉDERM on Instagram.
About Allergan Aesthetics
At Allergan Aesthetics, an AbbVie company, we develop, manufacture, and market a portfolio of leading aesthetics brands and products. Our aesthetics portfolio includes facial injectables, body contouring, plastics, skin care, and more. Our goal is to consistently provide our customers with innovation, education, exceptional service, and a commitment to excellence, all with a personal touch. For more information, visit www.AllerganAesthetics.com.
About AbbVie
AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women's health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.
Juvéderm® Collection of Fillers Important Information
INDICATIONS
Juvéderm® VOLUMA® XC injectable gel is indicated for deep (subcutaneous and/or supraperiosteal) injection for cheek augmentation to correct age-related volume deficit in the mid-face and for augmentation of the chin region to improve the chin profile in adults over the age of 21.
Juvéderm® VOLLURE® XC injectable gel is indicated for injection into the mid-to-deep dermis for correction of moderate to severe facial wrinkles and folds (such as nasolabial folds) in adults over the age of 21.
Juvéderm® VOLBELLA® XC injectable gel is indicated for injection into the lips for lip augmentation and correction of perioral rhytids, and for the improvement of infraorbital hollowing in adults over the age of 21.
Juvéderm® Ultra Plus XC and Juvéderm® Ultra XC injectable gels are indicated for injection into the mid-to-deep dermis for correction of moderate to severe facial wrinkles and folds (such as nasolabial folds).
Juvéderm® Ultra XC injectable gel is also indicated for injection into the lips and perioral area for lip augmentation in adults over the age of 21.
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
These products should not be used in patients who have severe allergies, marked by a history of anaphylaxis or history or presence of multiple severe allergies, and should not be used in patients with a history of allergies to Gram-positive bacterial proteins or lidocaine contained in these products.
WARNINGS
- Do not inject into blood vessels. Introduction of these products into the vasculature may lead to embolization, occlusion of the vessels, ischemia, or infarction. Take extra care when injecting soft-tissue fillers; for example, after insertion of the needle and just before injection, the plunger rod can be withdrawn slightly to aspirate and verify the needle is not intravascular, inject the product slowly, and apply the least amount of pressure necessary. Rare, but serious, adverse events associated with the intravascular injection of soft-tissue fillers in the face have been reported and include temporary or permanent vision impairment, blindness, cerebral ischemia or cerebral hemorrhage leading to stroke, skin necrosis, and damage to underlying facial structures. Immediately stop the injection if a patient exhibits any of the following symptoms: changes in vision, signs of a stroke, blanching of the skin, unusual pain during or shortly after the procedure. Patients should receive prompt medical attention and, possibly, evaluation by an appropriate healthcare professional specialist should an intravascular injection occur
- Product use at specific sites in which an active inflammatory process (skin eruptions such as cysts, pimples, rashes, or hives) or infection is present should be deferred until the underlying process has been controlled
PRECAUTIONS
- To minimize the risks of potential complications, this product should only be used by healthcare professionals with appropriate experience and training on facial anatomy and product use in indicated area(s), vasculature, safe injection techniques, and identification and management of potential adverse events, including intravascular complications
- The potential risks of soft-tissue injections should be discussed with patients prior to treatment to ensure they are aware of signs and symptoms of complications
- The safety and effectiveness for the treatment of anatomic regions other than indicated areas for each product have not been established in controlled clinical studies
- The safety for use of these products during pregnancy, in breastfeeding females, and in patients with known susceptibility to keloid formation, hypertrophic scarring, and pigmentation disorders has not been studied
- The safety for use of Juvéderm® VOLUMA® XC has been established in patients between 35 and 65 years of age for cheek augmentation and in patients between 22 and 80 years of age for chin augmentation
- The safety for use of Juvéderm® Ultra Plus XC and Juvéderm® Ultra XC in patients under 18 years, and Juvéderm® VOLLURE® XC and Juvéderm® Volbella® XC in patients under 22 years, has not been established
- As with all transcutaneous procedures, dermal filler implantation carries a risk of infection
- Dermal fillers should be used with caution in patients on immunosuppressive therapy
- Patients taking medications that can prolong bleeding (such as aspirin, nonsteroidal anti-inflammatory drugs, and warfarin) may experience increased bruising or bleeding at treatment sites
- Patients who experience skin injury near the site of implantation may be at a higher risk for adverse events
- If laser treatment, chemical peel, or any other procedure based on active dermal response is considered after treatment, or before skin has healed from a procedure prior to treatment, there is a possible risk of eliciting an inflammatory reaction at the injection site
- The safety for use of Juvéderm® VOLUMA® XC injectable gel in patients with very thin skin in the mid-face has not been established
- The safety of Juvéderm® VOLUMA® XC with cannula for cheek augmentation has not been established in patients with Fitzpatrick Skin Types V and VI
- Juvéderm® VOLUMA® XC was not evaluated in subjects with significant skin laxity of the chin, neck, or jaw in the chin augmentation study
- The effect of Juvéderm® VOLUMA® XC injection into the chin on facial hair growth has not been studied
- Patients may experience late-onset adverse events with use of these dermal fillers, and late-onset nodules with use of Juvéderm® VOLUMA® XC
- Based on preclinical studies, patients should be limited to 20 mL of any Juvéderm® injectable gel per 60 kg (130 lbs) body mass per year. The safety of injecting greater amounts has not been established
ADVERSE EVENTS
The most commonly reported side effects for Juvéderm® injectable gels were redness, swelling, pain, tenderness, firmness, lumps/bumps, bruising, discoloration, and itching. For Juvéderm® Volbella® XC, dryness was also reported. The majority were mild or moderate in severity. For Juvéderm® VOLUMA® XC, most resolved within 2 to 4 weeks. For Juvéderm® VOLLURE® XC, Juvéderm® Ultra Plus XC, or Juvéderm® Ultra XC, most resolved within 14 days; and for Juvéderm® Volbella® XC, most resolved within 30 days.
To report an adverse reaction with any product in the Juvéderm® Collection, please call the Allergan® Product Support Department at 1–877–345–5372. Please visit JuvedermDFU.com for more information.
Products in the Juvéderm® Collection are available only by a licensed physician or properly licensed practitioner.
References
- Allergan Data On File Monthly Tracking Report, 2020
- Allergan Data On File JUVÉDERM® VOLBELLA® XC Patient Label 2021
- Allergan Data On File Filler Situational Analysis 2020
- Allergan Data On File JUVÉDERM® VOLBELLA® XC Directions for Use 2021
- DOF Volbella Infraorbital Hollowing CSR Body Text 2019
SOURCE AbbVie
Posted: February 2022
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- FDA Approves Juvéderm Vollure XC for Correction of Facial Wrinkles and Folds in Adults - March 20, 2017
- FDA Approves Juvéderm Volbella XC for Use in Lips and Perioral Rhytids - June 1, 2016
- FDA Approves Juvéderm Ultra XC for Lip Augmentation - October 1, 2015
- FDA Approves Juvéderm Voluma XC to Correct Age-Related Volume Loss in the Cheek Area - October 23, 2013
- FDA Approves Juvéderm XC Containing Lidocaine to Correct Facial Wrinkles and Folds - February 1, 2010
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Juvederm (dermal filler) FDA Approval History
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