FDA Approves JUVÉDERM® VOLBELLA® XC For Undereye Hollows

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 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.

BOTOX ^® COSMETIC IMPORTANT SAFETY INFORMATION AND APPROVED USES

BOTOX ^® Cosmetic may cause serious side effects that can be life threatening. Get medical help right away if you have any of these problems any time (hours to weeks) after injection of BOTOX ^® Cosmetic :

• Problems swallowing, speaking, or breathing , due to weakening of associated muscles, can be severe and result in loss of life. You are at the highest risk if these problems are pre-existing before injection. Swallowing problems may last for several months.
• Spread of toxin effects . The effect of botulinum toxin may affect areas away from the injection site and cause serious symptoms including: loss of strength and all-over muscle weakness, double vision, blurred vision and drooping eyelids, hoarseness or change or loss of voice, trouble saying words clearly, loss of bladder control, trouble breathing, and trouble swallowing.

BOTOX ^® Cosmetic dosing units are not the same as, or comparable to, any other botulinum toxin product .

There has not been a confirmed serious case of spread of toxin effect when BOTOX ^® Cosmetic has been used at the recommended dose to treat frown lines, crow's feet lines, and/or forehead lines.

BOTOX ^® Cosmetic may cause loss of strength or general muscle weakness, vision problems, or dizziness within hours to weeks of taking BOTOX ^® Cosmetic. If this happens, do not drive a car, operate machinery, or do other dangerous activities .

Serious and/or immediate allergic reactions have been reported . They include: itching, rash, red itchy welts, wheezing, asthma symptoms, or dizziness or feeling faint. Get medical help right away if you are wheezing or have asthma symptoms, or if you become dizzy or faint.

Do not receive BOTOX ^® Cosmetic if you : are allergic to any of the ingredients in BOTOX ^® Cosmetic (see Medication Guide for ingredients); had an allergic reaction to any other botulinum toxin product such as Myobloc ^® (rimabotulinumtoxinB), Dysport ^® (abobotulinumtoxinA), or Xeomin ^® (incobotulinumtoxinA); have a skin infection at the planned injection site.

Tell your doctor about all your muscle or nerve conditions , such as ALS or Lou Gehrig's disease, myasthenia gravis, or Lambert-Eaton syndrome, as you may be at increased risk of serious side effects including difficulty swallowing and difficulty breathing from typical doses of BOTOX ^® Cosmetic.

Tell your doctor about all your medical conditions , including: plans to have surgery; had surgery on your face; have trouble raising your eyebrows; drooping eyelids; any other abnormal facial change; are pregnant or plan to become pregnant (it is not known if BOTOX ^® Cosmetic can harm your unborn baby); are breast-feeding or plan to (it is not known if BOTOX ^® Cosmetic passes into breast milk).

Tell your doctor about all the medicines you take , including prescription and over-the-counter medicines, vitamins, and herbal supplements. Using BOTOX ^® Cosmetic with certain other medicines may cause serious side effects. Do not start any new medicines until you have told your doctor that you have received BOTOX ^® Cosmetic in the past .

Tell your doctor if you have received any other botulinum toxin product in the last 4 months; have received injections of botulinum toxin such as Myobloc ^® , Dysport ^® , or Xeomin ^® in the past (tell your doctor exactly which product you received); have recently received an antibiotic by injection; take muscle relaxants; take an allergy or cold medicine; take a sleep medicine; take aspirin-like products or blood thinners.

Other side effects of BOTOX ^® Cosmetic include : dry mouth; discomfort or pain at the injection site; tiredness; headache; neck pain; and eye problems: double vision, blurred vision, decreased eyesight, drooping eyelids and eyebrows, swelling of your eyelids and dry eyes.

APPROVED USES

BOTOX ^® Cosmetic is a prescription medicine that is injected into muscles and used to temporarily improve the look of moderate to severe forehead lines, crow's feet lines, and frown lines between the eyebrows in adults.

For more information refer to the Medication Guide or talk with your doctor.

To report a side effect, please call Allergan at 1-800-678-1605.

Please see BOTOX ^® Cosmetic full Product Information including Boxed Warning and Medication Guide .

References

1. Allergan Data On File Monthly Tracking Report, 2020
2. Allergan Data On File JUVÉDERM ^® VOLBELLA ^® XC Patient Label 2021
3. Allergan Data On File Filler Situational Analysis 2020
4. Allergan Data On File JUVÉDERM ^® VOLBELLA ^® XC Directions for Use 2021
5. DOF Volbella Infraorbital Hollowing CSR Body Text 2019

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SOURCE AbbVie