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FDA Approves Juvéderm Voluma XC to Correct Age-Related Volume Loss in the Cheek Area

IRVINE, Calif. October 23, 2013 --(BUSINESS WIRE)--Allergan, Inc., (NYSE:AGN) today announced that the company has received approval from the U.S. Food and Drug Administration (FDA) to market Juvéderm Voluma™ XC, the first and only filler approved to temporarily correct age-related volume loss in the cheek area in adults over the age of 21. Juvéderm Voluma™ XC helps create a more youthful appearance to the face and provides natural-looking and long-lasting results up to two years with optimal treatment.1

“In the Juvéderm Voluma™ XC clinical trial, physicians and patients were able to see instant and visible results, including correction of age-related volume loss in the cheek area and a more youthful appearance to the face.”

“Since 2002, Allergan has remained the leader in the medical aesthetics category as a result of our continued commitment to research and development, which has led to the approval of innovative products such as BOTOX® Cosmetic and JUVÉDERM® XC,” said Scott M. Whitcup, M.D., Executive Vice President, Research and Development, Chief Scientific Officer, Allergan. “We are pleased that the FDA has now approved Juvéderm Voluma™ XC, the first product of its kind specifically formulated to correct age-related volume loss in the cheek area. Juvéderm Voluma™ XC represents the latest innovation in Allergan’s growing portfolio of facial aesthetic products developed to address previously unmet patient needs.”

Allergan conducted a pivotal clinical trial in the United States and Canada for submission to the FDA. The trial was designed to assess the safety and effectiveness of Juvéderm Voluma™ XC as a non-surgical option for patients desiring volume in the cheek area to correct age-related volume loss. The trial demonstrated that Juvéderm Voluma™ XC was an effective treatment compared to the control group, which did not receive treatment.

“As people age, the cheek area can lose volume, causing the cheeks to flatten out and the skin to droop and sag,” said Dr. Derek H. Jones, Associate Professor of Dermatology, UCLA, Founder and Medical Director, Skin Care and Laser Physicians of Beverly Hills, and clinical investigator in the Juvéderm Voluma™ XC pivotal study. “In the Juvéderm Voluma™ XC clinical trial, physicians and patients were able to see instant and visible results, including correction of age-related volume loss in the cheek area and a more youthful appearance to the face.”

Juvéderm Voluma™ XC is made with Allergan’s proprietary VYCROSS™ technology, an advanced manufacturing process that results in a smooth gel that flows easily and consistently. This unique formulation contributes to the lift capacity to correct volume loss in the cheek area and to the duration of the product.2,3 Additionally, Juvéderm Voluma™ XC contains a small amount of lidocaine which helps to numb the treatment area during the injection procedure.

The Juvéderm Voluma™ formulation without lidocaine was first introduced in Europe in 2005. Juvéderm Voluma™ with lidocaine was first introduced outside the U.S. in 2009. As of August 31, 2013, Juvéderm Voluma™ with lidocaine (branded as Juvéderm Voluma™ XC in the U.S.) is distributed in 72 countries, including markets in Europe, Latin America, Middle East, Asia Pacific, and Canada. The JUVÉDERM® family of products, including JUVÉDERM® Ultra and Ultra Plus, are marketed and sold in 85 countries outside the United States.4

“Now, with Juvéderm Voluma™ XC, the only FDA approved filler specifically developed for the cheek area, I have a new treatment that can help correct age-related volume loss, in addition to the other JUVÉDERM® products that help to smooth away wrinkles and folds in the lower-face,” said Dr. Jones.

The most common side effects observed in the clinical trial included temporary injection-site tenderness, swelling, firmness, lumps/bumps, bruising, pain, redness, discoloration, and itching. They were predominantly moderate (uncomfortable) in severity, with a duration of two to four weeks.

Juvéderm Voluma™ XC will be available in fall 2013.

For more information about the JUVÉDERM® family of products, please visit www.juvederm.com.

INDICATION

Juvéderm Voluma™ XC injectable gel is indicated for deep (subcutaneous and/or supraperiosteal) injection for cheek augmentation to correct age-related volume loss in the mid-face in adults over the age of 21.

IMPORTANT SAFETY INFORMATION

Are there any reasons why I should not receive Juvéderm Voluma™ XC?

Do not use the product if you have severe allergies with a history of severe allergic reactions (anaphylaxis), or if you are allergic to lidocaine or the proteins (gram-positive bacterial proteins) used to make the hyaluronic acid (HA) in Juvéderm Voluma™ XC.

What precautions should my doctor advise me about?

What are possible side effects?

Side effects are typically moderate (uncomfortable) and generally last 2 to 4 weeks. The most common side effects include temporary reactions at the treatment site such as tenderness, swelling, firmness, lumps/bumps, bruising, pain, redness, discoloration, and itching.

To report a side effect, please call Allergan Product Surveillance at 1-877-345-5372.

For more information, please see the About Safety page at www.juvederm.com or call the Allergan Product Support line at 1-800-766-0171.

Juvéderm Voluma™ XC injectable gel is available by prescription only.

About Allergan

Allergan is a multi-specialty health care company established more than 60 years ago with a commitment to uncover the best of science and develop and deliver innovative and meaningful treatments to help people reach their life’s potential. Today, we have approximately 11,200 highly dedicated and talented employees, global marketing and sales capabilities with a presence in more than 100 countries, a rich and ever-evolving portfolio of pharmaceuticals, biologics, medical devices and over-the-counter consumer products, and state-of-the-art resources in R&D, manufacturing and safety surveillance that help millions of patients see more clearly, move more freely and express themselves more fully. From our beginnings as an eye care company to our focus today on several medical specialties, including eye care, neurosciences, medical aesthetics, medical dermatology, breast aesthetics, obesity intervention and urologics, Allergan is proud to celebrate more than 60 years of medical advances and proud to support the patients and customers who rely on our products and the employees and communities in which we live and work. For more information regarding Allergan, go to: www.allergan.com.

Forward-Looking Statements

This press release contains "forward-looking statements," including the statements by Dr. Whitcup, and other statements regarding the potential FDA approval and product launch of Juvéderm Voluma™ XC. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from Allergan's expectations and projections. Risks and uncertainties include, among other things, general industry and medical device market conditions; challenges related to achieving regulatory approval from the FDA on a timely and cost-efficient manner; technological advances and patents attained by competitors; inconsistency of treatment results among patients; potential difficulties in manufacturing; challenges related to new product marketing, such as the unpredictability or market acceptance for new products and/or the acceptance of new indications for such products; and governmental laws and regulations affecting domestic and foreign operations. Allergan expressly disclaims any intent or obligation to update these forward-looking statements except as required by law. Additional information concerning these and other risks can be found in press releases issued by Allergan, as well as Allergan's public filings with the U.S. Securities and Exchange Commission, including the discussion under the heading "Risk Factors" in Allergan's most recent Annual Report on Form 10-K and any subsequent Quarterly Reports on Form 10-Q. Copies of Allergan's press releases and additional information about Allergan are available at www.allergan.com or you can contact the Allergan Investor Relations Department by calling 1-714-246-4636.

© 2013 Allergan, Inc. Irvine, CA 92612.
® and ™ marks owned by Allergan, Inc. JUVÉDERM® mark owned by Allergan Industrie, SAS

1 JUVÉDERM VOLUMA™ Patient Labeling, 2013
2 JUVÉDERM VOLUMA™ Directions for Use 2013, pg 11
3 Carruthers J, Carruthers A, Tezel A, Kraemer J, Craik L. Volumizing with a 20-mg/mL smooth, highly cohesive, viscous hyaluronic acid filler and its role in facial rejuvenation therapy. Dermatol Surg. 2010; 36(suppl3): 1886-1892. p1887A,B
4 Data on file, Allergan, Inc.

Source: Allergan, Inc.

Posted: October 2013

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