FDA Approves JUVÉDERM® VOLUMA™ XC for Enhancement of the Chin Region

IRVINE, Calif., June 15, 2020 /PRNewswire/ -- Today Allergan Aesthetics, an AbbVie company (NYSE: ABBV), announced the FDA approval of JUVÉDERM^® VOLUMA^™ XC for the augmentation of the chin region to improve the chin profile in adults over the age of 21.¹ As the category leader, the JUVÉDERM^® Collection of Fillers has the broadest portfolio of specifically tailored treatment options, and this latest approval marks their fifth approved indication in the U.S.^1-5

"When assessing facial anatomy, the chin is a critical component to facial balance, yet it is often overlooked. Due to its distinct gel properties and product profile, JUVÉDERM^® VOLUMA^™ XC is uniquely suitable to address this need," says Carrie Strom, Senior Vice President, AbbVie, and President, Global Allergan Aesthetics. "It's always rewarding when we can offer a safe and effective non-surgical alternative to patients. Addressing chin contour and shape is another way we are moving the market forward through our commitment to continued innovation."

JUVÉDERM^® VOLUMA^™ XC is the first and only filler to receive U.S. FDA approval for the augmentation of the chin region.¹ This approval marks the second indication for the product, which was previously approved by the FDA in 2013 for cheek augmentation to correct age-related mid-face volume deficit. ² JUVÉDERM^® VOLUMA^™ XC is currently the number one product in the JUVÉDERM^® portfolio in the U.S. and lasts up to two years with optimal treatment for cheek augmentation. ^1,7

"Within my practice, I've seen a growing demand for patients looking to achieve more balanced symmetry in the face. During facial assessments, most patients don't realize that chin augmentation is another component to achieving the facial harmony they desire," says Dee Anna Glaser, MD, dermatologist in St. Louis and clinical trial investigator. "This approval is a truly exciting milestone for providers as it signals another paradigm shift in the way we are able to approach a facial consultation. I am excited to educate patients that we have a safe and predictable non-surgical treatment option to address their concern."

In the U.S. pivotal study, JUVÉDERM^® VOLUMA™ XC was shown to be safe and effective for augmentation of the chin, with the majority of patients reporting high satisfaction throughout the 1-year follow-up.¹  

Since 2018, all clinical trials for the Allergan Aesthetics portfolio have included participants reflective of a diverse patient population and demographics, including varying genders, ages, races, and ethnicities.

To learn more about JUVÉDERM^® VOLUMA^™ XC and the full collection of fillers, please visit www.juvederm.com.

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^® VOLUMA™ XC Important Information

INDICATIONS
JUVÉDERM^® VOLUMA™ XC 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. 

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS
This product 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 this product.  

WARNINGS

• Do not inject into blood vessels. Introduction of this product into the vasculature may lead to embolization, occlusion of the vessels, ischemia or infarction. Take extra care when injecting soft-tissue fillers; for example, 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 risk of potential complications, this product should only be used by healthcare professionals who have appropriate training, experience, and knowledge of facial anatomy, and the product for use in deep injection for cheek and chin augmentation
• 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 the mid-face, chin, and pre-jowl sulcus regions have not been established in controlled clinical studies
• The safety for use during pregnancy, in breastfeeding females, and in patients with very thin skin in the mid-face region has not been established
• The safety has been established for use in patients between 35 and 65 years of age for cheek augmentation and patients between 22 and 80 years of age for chin augmentation
• The safety in patients with known susceptibility to keloid formation, hypertrophic scarring, and pigmentation disorders has not been studied
• As with all transcutaneous procedures, dermal filler implantation carries a risk of infection            
• Use with caution in patients on immunosuppressive therapy
• Patients who are using products 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
• Patients may experience late onset nodules with use of dermal fillers including JUVÉDERM^® VOLUMA™ XC
• The safety of JUVÉDERM^® VOLUMA™ XC with cannula for cheek augmentation has not been established in patients with Fitzpatrick Skin Types V and VI.
• In the chin study, the device was not evaluated in subjects with significant skin laxity of the chin, neck or jaw
• The effect of JUVÉDERM^® VOLUMA™ XC injection into the chin on facial hair growth has not been studied

ADVERSE EVENTS
Adverse events in > 5% of subjects were tenderness, firmness, swelling, lumps/bumps, pain, bruising, redness, discoloration, and itching. These events were predominately mild or moderate in severity across all studies and most resolved within 2-4 weeks.

For more information, please visit JuvedermDFU.com . To report an adverse reaction, please call Allergan at 1-800-433-8871.

JUVÉDERM^® VOLUMA™ XC is available only by a licensed physician or properly licensed practitioner.

References

1. JUVÉDERM^® VOLUMA™ XC Directions for Use, 2020.
2. JUVÉDERM^® VOLUMA™ XC Patient Labeling, 2019.
3. JUVÉDERM^® ULTRA XC Patient Labeling, 2019.
4. JUVÉDERM^® VOLBELLA™ XC Patient Labeling, 2019.
5. JUVÉDERM^® XC Patient Labeling, 2019.
6. JUVÉDERM^® VOLLURE™ XC Patient Labeling, 2019.
7. Allergan Data On File Proforma Sales, 2015.

SOURCE AbbVie