*Results derived from an animal model study comparing fillers.7
†Results from a 1-year, prospective, open-label, post-marketing study where HArmonyCa® and HArmonyCa® Lidocaine were injected in the midface of 140 patients with moderate to severe midface volume deficit. The primary endpoint was responder status based on EI-assessed MFVDS at Month 1. Secondary endpoints included responder status based on EI-assessed and participant-assessed GAIS, change from baseline on FACE-Q Satisfaction with Cheeks questionnaire, and change from baseline on FACE-Q Satisfaction with Facial Appearance questionnaire. The mITT population was all treated participants with a non-missing baseline MFVDS score. At Month 1, the MFVDS responder status (a participant with at least a 1-grade improvement on the MFVDS based on the EI’s live assessment of midface volume deficit) was 82.8% (95% CI: 75.7%–88.5%) in the mITT population for both treatment groups combined.2
‡The EI-assessed GAIS responder rate (improved or much improved) was 98.5% (132/134) at Month 1, 98.5% (130/132) at Month 3, 94.7% (126/133) at Month 6, 87.8% (115/131) at Month 9, and 75.6% (102/135) at Month 12. The participant-assessed GAIS responder rate (improved or much improved) was 91.8% (123/134) at Month 1, 86.4% (114/132) at Month 3, 81.2% (108/133) at Month 6, 75.4% (98/130) at Month 9, and 72.6% (98/135) at Month 12.2
§Results from a retrospective, non-interventional study assessing the incidence and severity of TEAEs in adults (N=403) treated with HArmonyCa® Lidocaine at six clinics in Brazil.9
¶In a post-marketing clinical analysis of HArmonyCa® (N=162), one unrelated serious AE was reported and one AE required medical intervention due to material migration into the lips and overcorrection.5
References
1. Data on file. DART trademark. Allergan Pharmaceuticals. October 28, 2025. 2. Gritti A, et al. J Cosmet Dermatol. 2025;24(9):e70430. 3. Allergan Aesthetics. HArmonyCa® Lidocaine DFU. November 14, 2025. 4. Urdiales-Gálvez F, et al. J Cosmet Dermatol. 2023;22(8):2186–2197. 5. Allergan Aesthetics. Data on file. HArmonyCa® Lidocaine. Clinical Study Report. July 2022. REF-99624. 6. Allergan Aesthetics. Data on file. ABVRRTI82655 M21-784: Safety and Efficacy. 7. Hee C, et al. Dermatol Surg. 2015;41:S373–S381. 8. Allergan Aesthetics. Data on file. ABVRRTI81261 Comparative Analysis of Bio-Stimulatory Effects. REF-139077. 9. Braz A, et al. Plast Reconstr Surg Glob Open. 2024;12(2):e5622.