fda approves allergans juvederm voluma xc 5f6220c927036

FDA Approves Allergan’s Juvederm Voluma XC

FDA Approves Allergan’s Juvederm Voluma XC

Las Vegas Plastic Surgery

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Allergan touts its product as the “First and Only Filler Approved in the U.S. to Correct Age-Related Volume Loss in the Cheek Area”

In our Las Vegas plastic surgery practice, we have seen patients that would benefit from additional volume to the face. With Juvederm Voluma XC, we have another modality that may be helpful. Every patient is different, and one should try to best match the modality with the individual patient. Time will tell if Voluma will be a viable asset in the treatment of this issue.

Here are some details about the new  product from the official Juvederm press release:

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(TM) 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(TM) 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)

“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(R) Cosmetic and JUVÉDERM(R) 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(TM) XC, the first product of its kind specifically formulated to correct age-related volume loss in the cheek area. JUVÉDERM VOLUMA(TM) XC represents the latest innovation in Allergan’s growing portfolio of facial aesthetic products developed to address previously unmet patient needs.”

“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(TM) XC pivotal study. “In the JUVÉDERM VOLUMA(TM) 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(TM) XC is made with Allergan’s proprietary VYCROSS(TM) 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(TM) XC contains a small amount of lidocaine which helps to numb the treatment area during the injection procedure.

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

“Now, with JUVÉDERM VOLUMA(TM) 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(R) 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(TM) XC will be available in fall 2013.

Jeffrey J. Roth, M.D., F.A.C.S.

Las Vegas Plastic Surgery

702-450-0777

www.jjrothmd.com

References:

(1) JUVÉDERM VOLUMA(TM) Patient Labeling, 2013 

(2) JUVÉDERM VOLUMA(TM) 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. 
 

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