WAIKOLOA, HAWAII – Juvederm Voluma XC continues to show significant results in extended follow-up data from the pivotal phase III trial that earned the product marketing approval from the Food and Drug Administration late last year as the first filler indicated specifically for treating age-related midface volume deficit.
One of the notable new findings: At 6 months post treatment, 73% of Voluma-treated study participants rated themselves as looking younger than at baseline – and by an average of 5 years less than their mean baseline chronologic age of 56 years. Moreover, at 24 months, 55% of patients said they felt that they still looked younger by an average of 3 years, Dr. Sue Ellen Cox reported at the Hawaii Dermatology Seminar sponsored by Global Academy for Medical Education/Skin Disease Education Foundation.
Dr. Sue Ellen Cox
"The improvement was really profound. What was also profound was how long it lasted. I’m now 3 years out seeing these patients and they still have retention of their product. So I am a believer," said Dr. Cox, a dermatologist at the University of North Carolina at Chapel Hill, who was principal investigator in the pivotal phase III trial.
Dr. Cox shared highlights of the extended follow-up data, along with her personal observations regarding how to use Voluma most effectively.
Voluma XC is a highly cohesive volumizing hyaluronic acid filler formulated at a concentration of 20 mg/mL. It fills what has been widely regarded as a major unmet need in aesthetic dermatology, said Dr. Cox
"It’s a wonderful filler we’re all really going to enjoy using. I think it’s going to prove to be everything we want it to be," she said.
The pivotal data reviewed by the FDA came from a 15-center, randomized, single-blind clinical trial including 235 Voluma-treated patients and 47 no-treatment controls. All patients had moderate or severe baseline midface volume deficits as reflected by scores of 3-5 on a standardized 0-5 scoring system. The active treatment group received one treatment with the option of a touch-up session a month later.
The primary study endpoint prespecified by the FDA was an improvement of at least 1 point between baseline and 6 months on the Mid-Facial Volume Deficit Scale (MFVDS). This endpoint was achieved in 86% of the Voluma group and 39% of controls. Moreover, 51% of the active treatment group had an improvement of 2 points or greater compared with 11% of controls. And 26% of the Voluma group, but none of the controls, showed a 2.5-point improvement or better.
The durability of the treatment response was noteworthy, Dr. Cox added. At 2 years, 67% of patients in the Voluma group maintained a clinically significant improvement based upon MFVDS scores.
Every 3 months for the 2 years of follow-up, patients were asked how they felt about their appearance. As Dr. Cox noted, this is the true litmus test for any aesthetic dermatology procedure. At 6 months, 90% of patients pronounced themselves satisfied with the improvement in their facial appearance. At 12 months, 82% said they were satisfied; and at 2 years post treatment, 76% of patients remained satisfied with their facial appearance.
At baseline, 67% of patients rated their midface appearance as making them look "very much" older; at 6 months post treatment, only 12% of patients felt that way. Similarly, at baseline 55%-66% of patients characterized their midface appearance as variously "very much" unattractive, sad, and/or tired; at 6 months post treatment, only 9%-11% of subjects did so.
Treatment of the nasolabial folds and tear ducts was not permitted in the pivotal trial. Yet by investigator assessment at 6 months’ follow-up 32% of the active treatment group had a clinically meaningful improvement of at least 1 point on the 5-point Nasolabial Fold Photo Severity Scale, compared with 8% of controls, said Dr. Cox. Moreover, 54% of Voluma-treated patients rated themselves as moderately, very much, or completely satisfied with the appearance of their tear trough area, a marked improvement over the 17% rate at baseline. These findings underscore the point that effectively reinflating the midface and reestablishing optimal proportion provides ancillary benefits that may render treatment of the tear troughs and nasolabial folds unnecessary, she said.
Common treatment side effects consisted of mild to moderate injection site tenderness, swelling, bruising, lumps and bumps, and pain. All cases of side effects resolved within 30 days, and most resolved within 2 weeks.
Dr. Cox reported acting as a consultant to Allergan and Medicis and serving as principal investigator in trials funded by those companies, as well as in studies funded by Revance and Kythera.