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The FDA has approved the cosmetic filler Juvéderm Voluma XC (Allergan), a hyaluronic acid filler. It is the first and only filler to be approved for the temporary correction of age-related volume loss in adult patients ages 21 and older.
The Food and Drug Administration has approved the cosmetic filler Juvéderm Voluma XC (hyaluronic acid/HA, Allergan).
The HA filler is the first and only filler to be approved for the temporary correction of age-related volume loss in adult patients ages 21 and older, according to a news release. The product is expected to be available this fall, Allergan states.
Juvéderm Voluma X, uses Allergan’s Vycross technology that results in a smooth gel. It also contains lidocaine to help numb the area during an injection procedure, the company states.
“We’re looking at something that has long life, it has reversibility, and it is a product that really is geared in terms of its molecular makeup to robustly treat the cheek in an efficient way,” says Chicago-based plastic surgeon Julius Few, M.D., who was one of the clinical site investigators in the study. He is clinical associate, University of Chicago Pritzker School of Medicine, plastic surgery, and founder of The Few Institute for Aesthetic Plastic Surgery.
“It is designed to lift,” says dermatologist Derek H. Jones, M.D., associate professor of dermatology, University of California, Los Angeles, and medical director of Skin Care and Laser Physicians of Beverly Hills. He also was a clinical investigator in the trial. “What makes it different is that it uses a lower molecular weight hyaluronic acid that allows for increased cross-linking that gives the product an ideal lift capacity for the midface.”
The approval follows the results of a single blinded controlled clinical trial conducted at 15 U.S. and two Canadian sites, which demonstrated efficacy and safety. The study was recently published in the Journal of Dermatologic Surgery.
Results demonstrated that almost 50 percent of patients were maintaining optimal correction at two years, Dr. Jones says; however, many will maintain the correction longer. Similarly, Dr. Few says he has patients demonstrating clinically significant results after almost three years.
The study enrolled 282 patients ages 35 to 65 with midface volume deficit. Forty-seven patients were randomized to a control group and 235 patients were treated in one or more of the following midface regions: the zygomaticomalar region, the anteromedial cheek and the submalar region.
Patients received touch-up treatment after 30 days as necessary and were followed up at one month, three months and then quarterly for up to two years, according to the study. Response was determined by two blinded investigators’ assessments at six months based on whether the patient had improved by one point or more on a validated six-month Mid-Face Volume Deficit Scale (MFVDS).
Dr. Few says dermatologists and plastic surgeons are going to be most concerned about patient satisfaction. He notes that 90 percent of patients reported feeling that they appeared, on average, five years younger at six months based on analysis of patient diaries. As far out as two years, patient satisfaction was at 76 percent.
The most common adverse effects seen during the clinical trial were injection site tenderness, bruising, redness, discoloration, swelling, lumps/bumps, firmness, itching, and pain that lasted approximately two to four weeks.