FDA approves cosmetic filler for adults with volume loss in cheeks

October 23, 2013

The product is the first and only filler to treat this condition.

 

The FDA has approved Juvederm Voluma XC, a cosmetic filler by Allergan, the first and only filler to temporarily correct age-related volume loss in the cheek area in adults who are older than 21 years. The product is expected to be available this fall, the manufacturer said.

Juvederm Voluma XC, formulated with Allergan’s Vycross technology for creation of a smooth gel, is indicated for injection into the mid-to-deep dermis to correct facial lines and nasolabial folds that are moderate to severe. The gel also contains lidocaine to help numb the area during the procedure.

The approval for Juvederm Voluma XC was based on a clinical trial in the United States and Canada that demonstrated the safety and efficacy of the gel in patients, compared to outcomes for a control group that was not treated with the gel.

“In the Juvederm 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,” said Dr. Derek H. Jones, associate professor of dermatology, UCLA, clinical investigator in the pivotal trial and founder and medical director of Skin Care and Laser Physicians of Beverly Hills.

The most common adverse effects seen during the clinical trial were tenderness at the injection site, bruising, redness, discoloration, swelling, lumps/bumps, firmness, itching, and pain that lasted approximately two to four weeks.

The product should not be used by patients with multiple allergies or a history of anaphylaxis, or by patients with a history of allergies to lidocaine or Gram-positive bacterial proteins. Its safety has not been established in pregnant or breast-feeding women or in patients with a history of excessive scarring and pigmentation disorders. In addition, the gel should be used with caution by patients taking immunosuppressive therapy, as there is an increased risk of infection.

For more information, visit the About Safety page at www.juvederm.com or call the support line at 800-433-8871.