A Prospective, Multicenter, Evaluator-Blind, Randomized, Controlled Study of Belotero Balance (+), a Hyaluronic-Acid Filler with Lidocaine, for Correction of Infraorbital Hollowing in Adults.

Abstract

The infraorbital hollow (IOH) is a concavity that interrupts the smooth transition between the lower eyelid and the cheek, resulting in a fatigued and aged appearance. Injectable fillers may be used to correct volume deficit in the under-eye area, restoring a more youthful appearance. To demonstrate the effectiveness and safety of a Cohesive Polydensified Matrix® (CPM) hyaluronic acid (HA) filler with lidocaine (Belotero Balance® (+)) for correcting volume deficit in the IOH. Eligible patients with a moderate or severe rating on the Merz Infraorbital Hollow Assessment Scale (MIHAS) were randomized 2:1 to treatment or control. Controls remained untreated until Week 8 and were then treated. Touch-up injections were allowed; retreatment was offered only in the treatment group. Effectiveness was evaluated by the MIHAS. Adverse events were recorded over a 76-week period. The estimated average response rate (≥ 1 point MIHAS improvement) was 80.6% [95% confidence interval (CI): 71.4%, 87.4%] in treated patients and 1.9% [95% CI: 0.3%, 10.2%] in controls at Week 8. The difference in estimated response rates was 78.7% [95% CI: 66.3%, 85.6%], demonstrating a statistically significant, superior response rate in treated patients compared to untreated controls. A total of 88/97 (90.7%) patients who responded to treatment at Week 8 retained improvement 48 weeks after treatment. Use of Belotero Balance (+) in the IOH had a favorable safety profile, with no unexpected adverse events reported. Belotero Balance (+) is a safe and effective treatment for correcting volume deficit in the IOH.