ABBV AbbVie Inc

• JUVÉDERM^® VOLUMA^® XC is the One and Only Hyaluronic Acid Dermal Filler Indicated to Treat Cheeks, Chin, and Now Moderate to Severe Temple Hollowing^1,2
• Only Allergan Aesthetics, the Makers of BOTOX^® Cosmetic (onabotulinumtoxinA), has FDA-Approved Injectables to Treat More Than 90% of the Face^2-8

IRVINE, Calif., Oct. 2, 2024 /PRNewswire/ -- Allergan Aesthetics, an AbbVie company (NYSE: ABBV), announces the national availability of JUVÉDERM^® VOLUMA^® XC for temple hollowing. Following its U.S. FDA approval in March 2024, JUVÉDERM^® VOLUMA^® XC is the first and only hyaluronic acid (HA) filler approved to treat moderate to severe temple hollowing in adults over 21.^1,2 The JUVÉDERM^® Collection of Fillers is the number one chosen HA dermal filler brand by patients and providers, and now offers the largest range of treatment indications to meet patients' aesthetic goals.^2-7

"In the months since approval, our focus has been on developing and implementing a robust training protocol designed to ensure providers are well versed in the science needed to inject the temple area," said Carrie Strom, President, Allergan Aesthetics and Senior Vice President, AbbVie. "We will continue to provide comprehensive training for this treatment area, as we do with all Allergan Aesthetics products. We look forward to seeing the beautiful results our customers will achieve by adding JUVÉDERM^® VOLUMA^® XC for temple into their pan-facial approach."

As the most awarded filler collection in the U.S.,⁹* the JUVÉDERM^® Collection of Fillers boasts impressive patient satisfaction. As a key product in the collection, JUVÉDERM^® VOLUMA^® XC when used in the temples, delivers:

• A natural look and feel: Approximately 90% of patients were satisfied with the natural look and feel of their temples at three months after temple treatment.^2†
• Long-lasting improvement: More than 85% of patients reported an overall aesthetic improvement one-month post-treatment, with results lasting up to 13 months.^11‡§
• High satisfaction: 98% of patients treated in the temple would recommend temple treatment to a friend.²
• Established safety: JUVÉDERM^® VOLUMA^® XC for temples has an acceptable safety profile and is approved for adults of all Fitzpatrick skin types over 21 years of age.¹⁰

"The number one facial concern patients have is the eye area,¹² so it is essential to consider treating the temples as part of a comprehensive treatment plan. With the approval and training-led launch of JUVÉDERM^® VOLUMA^® XC, licensed aesthetic providers like me receive advanced training to treat this area," said Board-certified plastic surgeon Christopher C. Surek, DO, FACS. "Treatment with JUVÉDERM^® VOLUMA^® XC in the temples creates a balanced and youthful appearance.¹ The efficacy of JUVÉDERM^® VOLUMA^® XC is evident in the immediate lift it creates,¹ making it an ideal choice for patients seeking subtle, natural-looking results."

Treatment of moderate to severe temple hollowing with JUVÉDERM^® VOLUMA^® XC is the newest indication for the JUVÉDERM^® Collection of Fillers, which currently offers six specifically designed formulated, modified HA fillers to address patients' varying aesthetic goals: JUVÉDERM^® VOLUMA^® XC, JUVÉDERM^® VOLBELLA^® XC, JUVÉDERM^® VOLLURE^® XC, JUVÉDERM^® Ultra Plus XC, JUVÉDERM^® Ultra XC, JUVÉDERM^® VOLUX^® XC.^2-7

Patients interested in learning more about JUVÉDERM^® VOLUMA^® XC for temple hollowing are encouraged to enroll in Allē, the Allergan Aesthetics loyalty rewards program. In serving more than seven million Members across ~30,000 practices to date, part of Allē's mission is to help educate consumers about aesthetic treatments, and to simplify office operations for practices. From its inception, Allē has disrupted the aesthetics industry by offering the most robust rewards program. Allē is the first and only loyalty program in the aesthetics market to also offer consumers the ability to earn points on over 50 non-Allergan Aesthetics treatments and brands. By providing Members with information, tools, and incentives, and now with flexible ways to pay though Allē Payment Plans powered by Cherry, Allē empowers consumers along their treatment journey, making the next product purchase or treatment closer within reach. 

Per FDA requirement for this indication, Allergan Aesthetics is providing a product training program for providers, which includes facial anatomy and considerations for patient selection, safe injection in this area, as well as identification and management of potential complications. Successful completion of this training is necessary prior to the administration of JUVÉDERM^® VOLUMA^® XC.

To learn more about the JUVÉDERM^® Collection of Fillers, visit www.juvederm.com and follow @JUVEDERM on social media. For aesthetic providers interested in learning more about injection training, please speak to your Allergan Aesthetics Business Development Manager.

* Based on a survey of 12 consumer lifestyle publications, 2014-2022.^9
† Based on subject self-assessments in the clinical study in the temples.^2,11
‡ With optimal treatment.^11
§ Based on independent Evaluating Investigator (EI) and participant Global Aesthetic Improvement Scale (GAIS) assessments of the temples.¹¹

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 and solutions 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, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X (formerly Twitter), and YouTube.

JUVÉDERM^® Injectable Gel Fillers Important Information 

APPROVED USES 

JUVÉDERM^® VOLUMA^® XC injectable gel is for deep injection in the cheek area to correct age-related volume loss, for augmentation of the chin region to improve the chin profile, and for augmentation of the temple region to improve moderate to severe temple hollowing in adults over 21. 

JUVÉDERM^® VOLUX^® XC injectable gel is for deep injection to improve moderate to severe loss of jawline definition in adults over the age of 21.

JUVÉDERM^® VOLLURE^® XC, JUVÉDERM^® Ultra Plus XC, and JUVÉDERM^® Ultra XC injectable gels are for injection into the facial tissue for the correction of moderate to severe facial wrinkles and folds, such as nasolabial folds. JUVÉDERM^® VOLLURE^® XC injectable gel is for adults over 21. 

JUVÉDERM^® Ultra XC injectable gel is also for injection into the lips and perioral area for lip augmentation in adults over 21. 

JUVÉDERM^® VOLBELLA^® XC injectable gel is for injection into the lips for lip augmentation and correction of perioral lines, and for injection into the undereye hollows to improve the appearance of undereye hollows in adults over the age of 21. 

IMPORTANT SAFETY INFORMATION 

Are there any reasons why I should not receive any JUVÉDERM^® formulation?
Do not use these products if you have a history of multiple severe allergies or severe allergic reactions (anaphylaxis), if you are allergic to lidocaine or the Gram-positive bacterial proteins used in these products, or if you have had previous allergic reactions to hyaluronic acid fillers. 

What warnings should my doctor advise me about? 

• One of the risks with using dermal fillers is the unintentional injection into a blood vessel. The chances of this happening are very small, but if it does happen, the complications can be serious and may be permanent. These complications, which have been reported for facial injections, can include vision abnormalities, blindness, stroke, temporary scabs, or permanent scarring of the skin. Most of these events are irreversible. 
• If you have changes in your vision, signs of a stroke (including sudden difficulty speaking, numbness or weakness in your face, arms or legs, difficulty walking, face drooping, severe headache, dizziness, or confusion), white appearance of the skin, or unusual pain during or shortly after treatment, you should notify your health care practitioner immediately.
• The use of dermal fillers where skin sores, pimples, rashes, hives, cysts, or infections are present should be postponed, as this may delay healing or make skin problems worse. 
• The effectiveness of removal of any dermal filler has not been studied. 

What precautions should my doctor advise me about? 

• JUVÉDERM^® VOLBELLA^® XC should only be injected into undereye hollows by doctors who have completed the necessary training for this treatment area. To find a doctor, visit Juvederm.com/find-a-specialist. Doctors who complete the training will be listed with a symbol 
• The safety of these products for use during pregnancy or while breastfeeding has not been studied 
• The safety of JUVÉDERM^® VOLUMA^® XC has not been studied in patients under 35 years or over 65 years for cheek augmentation, under 22 years or over 80 years for chin augmentation, and under 32 years or over 82 years for temple area augmentation. The safety of JUVÉDERM^® VOLUX^® XC, JUVÉDERM^® VOLLURE^® XC and JUVÉDERM^® VOLBELLA^® XC has not been studied in patients under 22 years, and the safety of JUVÉDERM^® Ultra Plus XC and JUVÉDERM^® Ultra XC has not been studied in patients under 18 years 
• The safety and effectiveness of treatment with JUVÉDERM^® products in anatomical regions outside of their approved uses have not been established in clinical studies 
• If you have a history of excessive scarring (thick, hard scars) or pigmentation disorders, treatment in these patients has not been studied and may result in additional scars or changes in pigmentation 
• If you are planning other procedures including laser treatments or a chemical peel, there is a possible risk of inflammation at the treatment site if these procedures are performed closely before or after JUVÉDERM^® injectable gel treatment 
• Tell your doctor if you are on therapy used to reduce your body's natural defense system (such as steroids, chemotherapy, and medicines to treat autoimmune diseases, HIV, and AIDs), as these may increase your risk of infection; and medications that can prolong bleeding (such as aspirin, ibuprofen, or other blood thinners), as these may result in increased bruising or bleeding at the injection site 
• Avoid applying makeup for 12 hours after treatment and minimize strenuous exercise, exposure to extensive sun or heat, and alcoholic beverages within the first 24 hours following treatment, as these may cause temporary redness, swelling, and/or itching at the injection site 
• JUVÉDERM^® VOLUMA^® XC was not studied in patients with significant loose skin of the chin, neck, or jaw 
• The effect of JUVÉDERM^® VOLUMA^® XC injection into the chin on facial hair growth has not been studied 
• Patients who experience skin injury near the site of JUVÉDERM^® VOLUMA^® XC injection may be at a higher risk for adverse events 
• Tell your doctor if you have already been injected with dermal fillers in the same area as the one(s) you are about to be treated for. This information helps your doctor decide when and whether you should get treatment

What are possible side effects of treatment?
The most commonly reported side effects with JUVÉDERM^® injectable gels were redness, swelling, pain, tenderness, firmness, lumps/bumps, bruising, discoloration, and itching. For JUVÉDERM^® VOLBELLA^® XC, dryness was also reported.

These side effects are consistent with other facial injection procedures and most will resolve within 30 days. Your doctor may choose to treat side effects persisting longer with antibiotics, steroids, or hyaluronidase (an enzyme that breaks down hyaluronic acid). 

As with all skin injection procedures, there is a risk of infection. 

To report a side effect with any product in the JUVÉDERM^® Collection, please call the Allergan^® Product Support Department at 1-877-345-5372. Please also visit Juvederm.com or talk to your doctor 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

IMPORTANT SAFETY INFORMATION
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. JUVÉDERM^® VOLUMA^® XC FDA Approval, 2024.
2. JUVÉDERM^® VOLUMA^® XC Directions for Use, June 2024.
3. Allergan Data on File, JUVÉDERM^® VOLUX^® XC Directions for Use, 2023.
4. Allergan Data on File, JUVÉDERM^® VOLBELLA^® XC Directions for Use, 2023.
5. Allergan Data on File, JUVÉDERM^® VOLLURE^® XC Patient Label, 2023.
6. Allergan Data on File, JUVÉDERM^® Ultra Plus XC Patient Label, 2023.
7. Allergan Data on File, JUVÉDERM^® Ultra XC Patient Label, 2023.
8. Allergan Data on File, BOTOX^® Cosmetic Prescribing Information, 2023.
9. Allergan Data on File, JUVÉDERM^® Awards, 2014-2022, 2022.
10. Allergan Data on File, JUVÉDERM^® VOLUMA XC Patient Label, 2024.
11. Allergan Data on File, JUVÉDERM^® VOLUMA^® XC M21-526 (1878-702-008) Final CSR, February 1, 2023.
12. Allergan Data on File, Facial Injectable Market Sizing Report, 2023.
13. Allergan Data on File, Consumer Filler Report, 2021.

© 2024 AbbVie. All rights reserved. BOTOX Cosmetic and its designs are trademarks of Allergan Holdings France SAS, an AbbVie company, or its affiliates.

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SOURCE AbbVie