FDA Okays Cheek Volume Filler Juvederm Voluma XC- by Dr. Mark Bishara, MD
The US Food and Drug Administration (FDA) has approved Juvéderm Voluma XC(Allergan) to correct age-related volume deficits in the midface in adults aged 21 years and older, the company has announced.
Juvéderm Voluma XC is a gel composed of cross-linked hyaluronic acid suspended in phosphate-buffered saline with 0.3% lidocaine. It is the first dermal filler approved in the United States specifically for deep (subcutaneous and/or supraperiosteal) injection for cheek augmentation to correct age-related volume deficit in the midface.
As reported by Medscape Medical News, the FDA's General and Plastic Surgery Devices Panel unanimously agreed that Juvéderm Voluma XC is effective and safe and that the benefits outweigh the risks, according to the clinical trial data presented to the panel.
"As people age, the cheek area can lose volume, causing the cheeks to flatten out and the skin to droop and sag," Derek H. Jones, MD, said in a company news release announcing the approval. Dr. Jones is associate professor of dermatology at the University of California, Los Angeles; founder and medical director of Skin Care and Laser Physicians of Beverly Hills; and clinical investigator in the Juvéderm Voluma XC pivotal study.
In the study, "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," Dr. Jones said.
JUVEDERM 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, JUVEDERM VOLUMA(TM) XC contains a small amount of lidocaine which helps to numb the treatment area during the injection procedure. The JUVEDERM VOLUMA(TM) formulation without lidocaine was first introduced in Europe in 2005. JUVEDERM VOLUMA(TM) with lidocaine was first introduced outside the U.S. in 2009. As of August 31, 2013, JUVEDERM VOLUMA(TM) with lidocaine (branded as JUVEDERM 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 JUVEDERM(R) family of products, including JUVEDERM(R) Ultra and Ultra Plus, are marketed and sold in 85 countries outside the United States.(4)
The most common adverse effects observed in the clinical trial included temporary injection-site tenderness, swelling, firmness, lumps/bumps, bruising, pain, redness, discoloration, and itching. The adverse effects were predominantly moderate (uncomfortable) in severity and lasted 2 to 4 weeks.
Juvéderm Voluma XC will soon be available at Dr. Mark Bishara's office. We will keep everyone updated when the product will be available in both of our Mansfield and Southlake offices.
This news is brought to you courtesy of Dr. Mark Bishara and The Paragon Plastic Surgery & Med Spa