Improved Infraorbital Hollowing in Chinese Adults Following Hyaluronic Acid-based Filler With Lidocaine (VYC-15L) Treatment.

Abstract

Infraorbital hollowing (IOH) is characterized by a sunken appearance of the lower eyelid. The soft tissue filler VYC-15L has been demonstrated to be effective in correcting IOH in US and European populations. The aim was to assess the safety and effectiveness of VYC-15L treatment in Chinese adults with moderate to severe IOH. In this randomized, multicenter, 12-month study, the primary endpoint was the proportion of ≥1-grade improvements on the Allergan Infraorbital Hollowing Scale (AIHS) according to the evaluating investigator (EI) at Month 3. Secondary endpoints included EI-based and participant-based assessments with the Global Aesthetic Improvement Scale (GAIS) and FACE-Q responses evaluated at Month 3. Safety was monitored throughout. The primary endpoint was met with a 94.6% AIHS responder rate in the VYC-15L group vs 0.0% in the delayed-treatment control (DTC) group (P < .0001). Significant GAIS improvements in VYC-15L vs DTC participants were seen in EI-assessed (99.1% vs 0.0%) and participant-assessed (95.6% vs 5.7%) responder rates at Month 3 (P < .0001). The mean change in FACE-Q scores was greater in the VYC-15L group than the DTC group at Month 3 (P < .0001). Improvements from VYC-15L treatment were seen across all effectiveness measures through Month 12. Mean pain scores were 2.9. Most injection site reactions were mild and resolved within 14 days. Forty-six participants (28.8%) experienced treatment-emergent adverse events (TEAEs), including treatment-related TEAEs (1.7%), which were blepharospasm (0.8%) and injection site bruising (0.8%). No serious TEAEs were reported. VYC-15L was effective and well tolerated for IOH correction in Chinese adults over up to 1 year.