Filler corrects age-related volume loss in cheek area
FDA approves marketing of Juvéderm Voluma XC in U.S.
Juvéderm Voluma XC is a filler that helps temporarily correct age-related volume loss in the cheek area in adults over the age of 21, according to Allergan, Inc.
The company announced in late October it had received approval from the U.S. Food and Drug Administration to market Juvéderm Voluma XC.
"Juvéderm Voluma XC represents the latest innovation in Allergan's growing portfolio of facial aesthetic products developed to address previously unmet patient needs," said Scott M. Whitcup, M.D., Executive Vice President, Research and Development, Chief Scientific Officer, Allergan.
Allergan said it conducted a pivotal clinical trial in the U.S. 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.
According to Allergan, 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. "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 the company says 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.
Additionally, Allergan says Juvéderm Voluma XC contains a small amount of lidocaine which helps to numb the treatment area during the injection procedure.
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. According to Allergan, they were predominantly moderate (uncomfortable) in severity, with a duration of two to four weeks.
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