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FDA Approves Juvéderm Volbella XC

FDA Approves Juvéderm Volbella XC for Use in Lips and Perioral Rhytids

DUBLIN, June 1, 2016 /PRNewswire/ -- Allergan plc, (NYSE: AGN), a leading global pharmaceutical company, today announced that the company has received approval from the U.S. Food and Drug Administration (FDA) to market Juvéderm Volbella® XC, for use in the lips for lip augmentation and for correction of perioral rhytids, commonly referred to as perioral lines, in adults over the age of 21.1 In clinical trials, Juvéderm Volbella® XC was found to effectively increase lip fullness and soften the appearance of lines around the mouth in a majority of subjects through one year.1,2*

"Many of my patients are very bothered by the lines that can appear around the lips, known as perioral rhytids. Additionally, when seeking lip augmentation, patients want a smooth, result that is not drastic" said Dr. David E. Bank, clinical trial investigator and founder of The Center for Dermatology, Cosmetic & Laser Surgery. "Juvéderm Volbella® XC adds fullness to the lips and softens the appearance of the lines around the lips.2 With Juvéderm Volbella® XC I am able to subtly enhance my patients' pout."

"The FDA approval of Juvéderm Volbella® XC further demonstrates Allergan's commitment to developing advanced products and technologies that allow healthcare providers to better address evolving patient needs," said Bill Meury, Chief Commercial Officer, Allergan. "Additionally, this approval brings to market a product unlike anything that is currently available in the United States. Juvéderm Volbella® XC is formulated with VYCROSS®,2 a proprietary filler technology from Allergan, which yields smooth products that have been engineered to address specific patient concerns such as lip fullness, age-related volume loss in the cheek area, or perioral rhytids.3"

VYCROSS® blends different molecular weights of hyaluronic acid which contributes to the gel's duration.1,3 In addition, Juvéderm Volbella® XC has been customized with a lower HA concentration (15 mg/mL), while still providing the long-lasting results healthcare providers expect from the JUVÉDERM® collection of fillers.1,4,5,6,7,8 This makes Juvéderm Volbella® XC a soft, smooth gel appropriate for adding subtle volume to the lips and softening the appearance of perioral lines.1 Allergan first debuted this innovative VYCROSS® technology in the U.S. in 2013 with the FDA approval of Juvéderm Volbella® XC for age-related mid-face volume loss.4 Now Juvéderm Volbella® XC is the latest addition to the JUVÉDERM® collection of fillers, the number one selling collection of dermal filler products in the world,9 to receive FDA approval.

The safety and effectiveness of Juvéderm Volbella® XC has been demonstrated in several clinical trials including the U.S. pivotal study where 168 subjects were treated with Juvéderm Volbella® XC. A 5-point scale was used to evaluate the effectiveness of the product for lip fullness and a 4-point scale to evaluate the effectiveness of the product for smoothing lines around the mouth.2 Approximately two-thirds of subjects treated with Juvéderm Volbella XC showed improvement in lip fullness and perioral lines through 1 year. The safety of Juvéderm Volbella® XC was observed to be similar to that of the control. The most common side effects were temporary responses at the treatment site such as swelling, tenderness, bruising, firmness lumps/bumps, rednesss, pain, discoloration, and itching. Most of these side effects resolved within 30 days.2

Juvéderm Volbella® XC was first approved in Europe in 2011. Currently, Juvéderm Volbella® XC is distributed in more than 70 countries, including markets in Europe, Latin America, Middle East, Asia Pacific, and Canada. The JUVÉDERM® family of products, including JUVÉDERM® Ultra XC and JUVÉDERM® Ultra Plus XC are marketed and sold in more than 80 countries outside the United States.10

Juvéderm Volbella® XC will be available to patients in October 2016. For more information about Juvéderm Volbella® XC and the JUVÉDERM® collection of fillers or to find a doctor, please visit www.juvederm.com.

Juvéderm Volbella® XC Important Information

APPROVED USES

Juvéderm Volbella® XC injectable gel is for injection into the lips for lip augmentation and for correction of perioral rhytids in adults over the age of 21.

IMPORTANT SAFETY INFORMATION

Are there any reasons why I should not receive Juvéderm Volbella® XC injectable gel?

Do not use these products if you have a history of multiple severe allergies or severe allergic reactions (anaphylaxis), or if you are allergic to lidocaine or Gram-positive bacterial proteins used in these products.

What precautions should my doctor advise me about?

What are possible side effects?

The most common side effects include swelling, tenderness, bruising, firmness, lumps/bumps, redness, pain, discoloration, and itching. Most side effects are mild or moderate and last 30 days or less.

One of the risks with using this product is unintentional injection into a blood vessel, and while rare, 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.

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

To report a side effect with Juvéderm Volbella® XC or for product information, please call Allergan at 1-800-624-4261. Please also visit Juvederm.com for more information.

Available by prescription only.

* Including optional touch up at 1 month for optimal correction

References:

1. JUVÉDERM VOLBELLA® XC Directions for Use, 2016.
2. JUVÉDERM VOLBELLA® XC Patient Labeling, 2016.
3. Data on File VYCROSS™: An Innovative Dermal Filler Technology, 2013.
4. JUVÉDERM VOLUMA® XC Directions for Use, 2013.
5. JUVÉDERM® Ultra XC Directions for Use, 2015.
6. JUVÉDERM® Ultra Plus XC Directions for Use, 2011.
7. Data On File, Allergan, DOF Swelling Comparison.
8. Pierre S, Liew S, Bernardin A. Basics of Dermal Filler Rheology. American Society for Dermatologic Surgery. 2015; 1:S120-6.
9. Data on File, Allergan, Proforma Sales JUVÉDERM VOLUMA®, 2015.
10. Data on File, Allergan, Inc. Filler Distribution Matrix, 2016

About Allergan

Allergan plc (NYSE: AGN), headquartered in Dublin, Ireland, is a unique, global pharmaceutical company and a leader in a new industry model – Growth Pharma. Allergan is focused on developing, manufacturing and commercializing innovative branded pharmaceuticals, high-quality generic and over-the-counter medicines and biologic products for patients around the world.

Allergan markets a portfolio of best-in-class products that provide valuable treatments for the central nervous system, eye care, medical aesthetics, gastroenterology, women's health, urology, cardiovascular and anti-infective therapeutic categories, and operates the world's third-largest global generics business, providing patients around the globe with increased access to affordable, high-quality medicines. Allergan is an industry leader in research and development, with one of the broadest development pipelines in the pharmaceutical industry and a leading position in the submission of generic product applications globally.

With commercial operations in approximately 100 countries, Allergan is committed to working with physicians, healthcare providers and patients to deliver innovative and meaningful treatments that help people around the world live longer, healthier lives.

For more information, visit Allergan's website at www.Allergan.com.

Forward-Looking Statement

Statements contained in this press release that refer to future events or other non-historical facts are forward-looking statements that reflect Allergan's current perspective of existing trends and information as of the date of this release. Except as expressly required by law, Allergan disclaims any intent or obligation to update these forward-looking statements. Actual results may differ materially from Allergan's current expectations depending upon a number of factors affecting Allergan's business. These factors include, among others, the difficulty of predicting the timing or outcome of FDA approvals or actions, if any; the impact of competitive products and pricing; market acceptance of and continued demand for Allergan's products; difficulties or delays in manufacturing; and other risks and uncertainties detailed in Allergan's periodic public filings with the Securities and Exchange Commission, including but not limited to Allergan's Annual Report on Form 10-K for the year ended March 31, 2016(certain of such periodic public filings having been filed under the "Actavis plc" name). Except as expressly required by law, Allergan disclaims any intent or obligation to update these forward-looking statements.

SOURCE Allergan plc

Posted: June 2016

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