Cosmetic filler approved for adults with volume loss in cheeks

FDA has approved Juvederm Voluma XC, a cosmetic filler by Allergan, 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.

Juvederm Voluma XC’s approval, based on a clinical trial in the United States and Canada, demonstrated that the gel was safe and effective in patients compared to 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 about 2 to 4 weeks.

The product should not be used in patients with multiple allergies or a history of anaphylaxis and in 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 for 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 1-800-433-8871.