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
“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.”
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