Effectiveness of Volbella (VYC-15L) for Infraorbital Hollowing: Patient-Reported Outcomes From a Prospective, Multicenter, Single-Blind, Randomized, Controlled Study.

BACKGROUND: Infraorbital hollowing can be addressed with hyaluronic acid soft tissue fillers. A prospective, multicenter, evaluator-blinded, randomized, controlled study (NCT03418545) demonstrated the safety and effectiveness of Juvéderm Volbella XC (VYC-15L, Allergan Aesthetics, an AbbVie company, Irvine, CA) in adults seeking correction for infraorbital hollows.

OBJECTIVE: The objective of the current analysis was to examine patient-reported outcomes (PROs) from the clinical study.

METHODS: Participants were randomized 3:1 to the VYC-15L treatment group or the no-treatment control group. Outcome measurements included: evaluating investigator (EI)- and participant-assessed Global Aesthetic Improvement Scale (GAIS) scores, as well as participant responses to the FACE-Q Appraisal of Lower Eyelids, questions on treatment satisfaction, the extent to which they were bothered by dark circles under their eyes, and willingness to recommend treatment to a friend.

RESULTS: The modified intent-to-treat population included 135 participants (median age, 47 years; 91.9% female). At Month 3, the majority of VYC-15L-treated participants showed improvements in the EI- and participant-assessed GAIS. The mean change from baseline to Month 3 score (32.7% increase) showed statistically significant improvement (mean: 17.8, SD: 19.8, p < 0.0001). At Months 3 and 12 post-treatment, most VYC-15L-treated participants reported feeling satisfied with treatment and not feeling moderately or very bothered by dark circles under their eyes, and would recommend treatment to a friend.

CONCLUSIONS: The current analysis demonstrated the effectiveness of VYC-15L treatment to reduce infraorbital hollowing and to improve overall satisfaction using validated PROs. Participant-assessed improvements aligned with EI-assessed outcomes and lasted through 1 year.