JUVÉDERM® VOLUMA® XC For Temple Hollows Receives U.S. FDA Approval

Rhea-AI Summary

Allergan Aesthetics, an AbbVie company, receives U.S. FDA approval for JUVÉDERM® VOLUMA® XC, the first hyaluronic acid dermal filler for temple hollowing. Results last up to 13 months with 80% improvement in temple hollowing. The approval addresses a significant unmet need in aesthetics.

Positive

• Allergan Aesthetics, under AbbVie, gains FDA approval for JUVÉDERM® VOLUMA® XC for temple hollowing treatment.
• JUVÉDERM® VOLUMA® XC is the first HA dermal filler approved for moderate to severe temple hollowing in adults over 21.
• Results from treatment last up to 13 months with significant improvement in temple hollowing.
• Clinical study shows over 80% satisfaction with balanced, well-proportioned, and symmetric face post-treatment.
• More than 85% satisfaction reported with youthful appearance and temple shape complementing facial structure.
• AMI to train providers on safe and effective treatments using Allergan Aesthetics products for 90% of the face.
• Product training program provided for facial anatomy, safe injection, and complication management.
• JUVÉDERM® VOLUMA® XC also indicated for cheek augmentation and chin profile improvement.
• Treatment expected to be available by the end of the year after completion of training.
• Subjects in clinical study reported mild to moderate treatment site responses, mostly resolving within three days.

Negative

• None.

Insights

Medical Research Analyst

The FDA approval of JUVÉDERM® VOLUMA® XC for temple hollowing represents a significant milestone in aesthetic medicine. This approval not only expands the indications for a well-established product but also taps into a growing market segment focused on non-invasive cosmetic procedures. The clinical study results, indicating over 80% improvement in subjects and high satisfaction rates, suggest a strong market acceptance potential. However, long-term data on efficacy and safety will be critical for sustained market confidence.

From an investment perspective, this development could have positive implications for AbbVie's stock, as it diversifies the application of its product portfolio. The ability to address a broader range of aesthetic concerns can lead to increased market share and customer loyalty. Nevertheless, investors should monitor post-market surveillance data and consumer feedback to assess the ongoing impact on the company's financial performance.

Market Research Analyst

The aesthetic market has been experiencing a consistent rise in consumer demand for minimally invasive procedures that offer natural-looking results. The approval of JUVÉDERM® VOLUMA® XC for temple hollowing aligns with this trend. By providing training programs for providers, Allergan Aesthetics ensures a high standard of practice, which could enhance brand reputation and drive demand.

The product's unique selling proposition of lasting up to 13 months offers a competitive edge over shorter-term solutions. However, the market response will depend on the balance between the product's cost, effectiveness and any emerging competition. Strategic marketing and education campaigns will be vital in maximizing the uptake of the new treatment indication.

Financial Analyst

The FDA's approval of a new indication for an existing product can have a positive effect on AbbVie's revenue stream. This approval potentially opens up a new revenue channel and could lead to an uptick in sales. The training requirement set by the FDA before administration suggests a controlled rollout, which may initially limit revenue growth but could ensure long-term success through provider competence and patient safety.

Investors should consider the potential for increased R&D expenses associated with the training programs and post-approval studies. However, the ability to leverage an existing product for a new application is an efficient use of resources that could lead to favorable profit margins. The key factor will be the adoption rate among healthcare providers and the subsequent consumer demand.

THE FIRST AND ONLY HYALURONIC ACID DERMAL FILLER APPROVED FOR THE IMPROVEMENT OF MODERATE TO SEVERE TEMPLE HOLLOWING¹

IRVINE, Calif., March 5, 2024 /PRNewswire/ -- Today, Allergan Aesthetics, an AbbVie company (NYSE: ABBV), announced the U.S. FDA approval of JUVÉDERM^® VOLUMA^® XC for injection in the temple region to improve moderate to severe temple hollowing in adults over the age of 21.¹ JUVÉDERM^® VOLUMA^® XC is the first and only hyaluronic acid (HA) dermal filler to receive U.S. FDA approval for the improvement of moderate to severe temple hollowing with results lasting up to 13 months with optimal treatment.*¹

"The approval of JUVÉDERM^® VOLUMA^® XC to treat temple hollows further demonstrates Allergan Aesthetics commitment to innovation and addressing patient needs," said Carrie Strom, President, Allergan Aesthetics and Senior Vice President, AbbVie. "This is the first U.S. FDA approval of a hyaluronic acid dermal filler for use in the upper face and addresses a real unmet need for patients."

JUVÉDERM^® VOLUMA^® XC temporarily adds volume to immediately lift and augment the shape, contour, and structure of the temple, creating a smooth transition from the cheekbone to the forehead, balancing a patient's overall facial shape.¹ In a clinical study, more than 80% of subjects had at least a one-point improvement in moderate to severe temple hollowing three months after treatment, and the improvement lasted for more than one year (73%).¹ Additionally, more than 85% of clinical trial subjects were satisfied with how balanced, well-proportioned, and symmetric their face looked three months after treatment.¹

In the clinical study, 68% of subjects reported satisfaction with how fresh their face looked, while 73% reported satisfaction with how rested their face appeared three months after treatment.¹ Additionally, upwards of 80% of subjects were satisfied with how youthful their temples made them look and how well the shape of their temples complemented the shape of their face three months after treatment.¹ With this addition, the Allergan Medical Institute (AMI) team can train aesthetic providers on safe and effective treatments using the Allergan Aesthetics portfolio to address 90% of the face.

"As an AMI trainer, I am excited to start training injectors on how to use JUVÉDERM^® VOLUMA^® XC to help address moderate to severe temple hollowing while reinforcing how treatment in this important area fits into a full-face approach that enhances facial balance (framing) and contour for my patients seeking subtle improvement," said Dr. Deirdre Hooper, board-certified dermatologist at Audubon Dermatology, and clinical trial investigator. "In the clinical study, we found that patients said they looked an average of five years younger six months after JUVÉDERM^® VOLUMA^® XC treatment.¹ Additionally, more than 85% of clinical study participants were satisfied with the treatment and would recommend it to a friend more than one year after treatment.¹ Once training is completed, injectors like me will be able to offer patients true pan-facial assessments and treatments for safe, repeatable, and optimal results using the Allergan Aesthetics portfolio of products."

Per FDA requirement for this new 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, and as such, Allergan Aesthetics anticipates that treatment in the temples with JUVÉDERM^® VOLUMA^® XC will be available towards the end of this year.

In a randomized, controlled, multicenter clinical study to evaluate the safety and effectiveness of JUVÉDERM^® VOLUMA^® XC for correction of temple hollowing, 112 subjects were randomized to a treatment group and received injections in the temple area during the primary phase of the study; 58 subjects were randomized to a no-treatment control group.¹ Touch-up treatments occurred approximately 30 days after initial injection, if needed.¹ After the three-month blinded "no treatment" control period, control subjects were offered treatment; 53 control subjects elected to receive treatment.² A total of 40 treatment-group subjects opted for the optional maintenance treatment, which was offered to the treatment group 13 months after the last treatment.²

Subjects used electronic diaries to record specific signs and symptoms of treatment site responses (TSR) experienced during the first 14 days after the initial touch-up and maintenance treatments.² Subjects in the initial treatment group continued to use the electronic diary on even-numbered days from day 16 to day 30 to record specific signs and symptoms of TSRs.² Subjects rated each TSR listed on the diary as "Mild (barely noticeable)," "Moderate (uncomfortable)," "Severe (severe discomfort)," or "None."²

After initial treatment with JUVÉDERM^® VOLUMA^® XC, 59% of the subjects with diary entries reported experiencing at least one TSR and 70.5% of subjects rated TSRs as mild or moderate (26.3%) in severity, with a majority (60%) of all reported TSRs resolving within three days.² The incidence of TSRs for the touch-up and maintenance treatments was lower than that for initial treatment.²

JUVÉDERM^® VOLUMA^® XC, one of six specifically designed products in the JUVÉDERM^® Collection of Fillers, is currently also indicated for deep (subcutaneous and/or supraperiosteal) injection for cheek augmentation to correct age-related volume loss in the mid-face, and for augmentation of the chin region to improve the chin profile.^3,4

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.

*Some patients may require a touch-up treatment to achieve desired result.

JUVÉDERM^® VOLUMA^® XC Injectable Gel 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.

IMPORTANT SAFETY INFORMATION

Are there any reasons why I should not receive any JUVÉDERM^® formulation?
Do not use if you have a history of multiple severe allergies or severe allergic reactions (anaphylaxis), or 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 until healing is complete, as these could delay healing or make your skin problems worse.
• The effectiveness of removal of any dermal filler has not been studied.

What precautions should my doctor advise me about?

• Avoid applying makeup for 12 hours after treatment and minimize strenuous exercise and exposure to extensive sun or heat within the first 24 hours following treatment. Exposure to any of these may cause temporary redness, swelling, and/or itching at the injection site
• Tell your doctor if you are pregnant or breastfeeding. 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 and effectiveness of treatment with JUVÉDERM^® products in anatomical regions outside of their approved uses have not been established in clinical studies
• Tell your doctor if you have a history of excessive scarring (thick, hard scars) or pigmentation disorders. The safety of JUVÉDERM^® VOLUMA^® XC in patients with a history of excessive scarring or pigmentation disorders has not been studied. Use in these patients may result in additional scars or changes in pigmentation
• 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
• 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
• 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 have already been injected with dermal fillers in the same area as the one(s) you are about to be treated for

What are possible side effects?
The most common reported side effects were tenderness, firmness, swelling, lumps/bumps, pain, bruising, redness, discoloration, and itching. The majority were mild or moderate in severity across all studies and resolved within 2 to 4 weeks.

Your doctor may choose to treat side effects persisting over 30 days 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.

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.

References

1. JUVÉDERM^® VOLUMA^® XC Patient Labeling for Temple. 2024.
2. JUVÉDERM^® VOLUMA^® XC Directions for Use. 2024.
3. JUVÉDERM^® VOLUMA^® XC Patient Labeling for Cheek. 2019.
4. JUVÉDERM^® VOLUMA^® XC Patient Labeling for Chin. 2020.

 

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SOURCE AbbVie

FAQ

What is the FDA approval announced by Allergan Aesthetics, an AbbVie company?

Allergan Aesthetics received U.S. FDA approval for JUVÉDERM® VOLUMA® XC for temple hollowing treatment.

What is unique about JUVÉDERM® VOLUMA® XC in terms of temple hollowing treatment?

JUVÉDERM® VOLUMA® XC is the first hyaluronic acid dermal filler approved for moderate to severe temple hollowing in adults over 21.

How long do the results of JUVÉDERM® VOLUMA® XC last?

Results from the treatment with JUVÉDERM® VOLUMA® XC can last up to 13 months.

What percentage of improvement in temple hollowing was observed in the clinical study?

The clinical study showed that more than 80% of subjects had at least a one-point improvement in moderate to severe temple hollowing.

What is the satisfaction rate among subjects regarding the post-treatment appearance?

Over 85% of clinical trial subjects were satisfied with how balanced, well-proportioned, and symmetric their face looked after the treatment.

What is the role of AMI in the training of providers?

AMI will train aesthetic providers on safe and effective treatments using Allergan Aesthetics products for 90% of the face.

What is the requirement for providers before administering JUVÉDERM® VOLUMA® XC?

Providers need to complete a product training program on facial anatomy, safe injection, and complication management.

Apart from temple hollowing, what other indications does JUVÉDERM® VOLUMA® XC have?

JUVÉDERM® VOLUMA® XC is also indicated for cheek augmentation to correct age-related volume loss and chin profile improvement.

When is the treatment with JUVÉDERM® VOLUMA® XC expected to be available?

Treatment in the temples with JUVÉDERM® VOLUMA® XC is anticipated to be available by the end of this year after training completion.

How did subjects in the clinical study report the treatment site responses?

Subjects in the clinical study reported mild to moderate treatment site responses, with a majority resolving within three days.