Allergan Aesthetics launches HArmonyCa™ with Lidocaine, its first dual-effect Hybrid Injectable

---- The dual-effect Hybrid Injectable contains two active ingredients, hyaluronic acid (HA) - a well-known ingredient found in facial fillers¹ - and calcium hydroxyapatite (CaHA) which is known to help stimulate collagen production^2,3 ---

---- In one single injection HArmonyCa^TM offers the potential of an immediate lift^4§§ effect from HA and sustained collagen stimulation from CaHA^5††, and may be suitable for people exhibiting signs of ageing²----

---- Over 90% [91.6%, N=162] of patients reported improvement in general appearance of facial areas following treatment with HArmonyCa^TM6§# ----

MONACO, April 1, 2022 /PRNewswire/ -- Today, at the Aesthetic & Anti-Aging Medicine World Congress (AMWC) in Monaco Allergan Aesthetics, an AbbVie Company, a global leader in medical aesthetic treatments and maker of Juvéderm® facial fillers and CoolSculpting® body contouring treatment, announces its entry into the category of Hybrid Injectables with the launch of HArmonyCa™ with Lidocaine.²

Exploring new possibilities

As market leader Allergan Aesthetics looks to further develop this exciting category of Hybrid Injectables by introducing its first dual-effect product, which combines the two active ingredients - hyaluronic acid (HA) and calcium hydroxyapatite (CaHA) - in one injection.² The treatment may offer the improvement of an immediate lift⁴§§ from HA, plus a sustained lifting effect from CaHA causing new collagen production.⁵†† In a late follow- up satisfaction cohort (N=45) of a post marketing clinical follow up of safety and performance of HArmonyCa^TM (N=162), a majority of patients reported a high user satisfaction (mean 4.1 out of 5) for overall satisfaction, and likeliness to repeat similar treatment up to 19 months after treatment with HArmonyCa^TM.^6 §||||

The science

HArmonyCa^TM is intended for facial soft tissue augmentation via injection into deep dermal and sub-dermal layers.² It is a dual-effect Hybrid Injectable containing:

• Cross-linked HA gel, which may provide an immediate lifting effect that is mouldable,⁷ allowing a qualified aesthetic practitioner to adjust the implant shape following administration^2,8 
• CaHA microspheres, which support the body's own collagen production by inducing the formation of collagen fibres^2,3,9

The hyaluronic acid particles work deep within the skin, where they help plump it for an immediate lifting effect,^7† while the CaHA microspheres work to support the body's own collagen production, so new collagen fibres start to grow.^3,9 Newly formed collagen fibres may be present as early as one week following treatment.^5††

Dr. André Braz, Brazil comments, "The texture of the skin changes as we age, and laxity or sagging can become a problem. Hyaluronic acid may help by providing an immediate lift, while calcium hydroxyapatite may be used to improve facial architecture and is associated with a sustained lifting effect from new collagen production. The combination of HA and CaHA in one HArmonyCa™ injection is an exciting new option for patients and aesthetic practitioners alike."

The multi-dimensional needs of the ageing face 
Loss of facial volume and changes to the soft-tissue are two of the most common signs of ageing.^10,11,12 In global  research¹³ exploring people's attitudes to ageing and aesthetics, almost all respondents (96%, N=12,360)¹³ had a concern about an area of their face, with more than a third stating they were concerned about the quality of their skin (40%, N=12,360)¹³ or its loss of tightness (39%, N=12,360).¹³  

When asked if they would consider a non-surgical aesthetic treatment  that stimulates their body to increase its production of collagen in the skin two thirds of people said they would (67%, N=12,360).¹³ 

Carrie Strom, SVP, AbbVie and President, Global Allergan Aesthetics notes, "The launch of HArmonyCa™ with Lidocaine represents Allergan Aesthetics' continued commitment to providing the latest innovations, treatments and possible outcomes for patients. We are driven by leading-edge science and are continually looking to diversify our portfolio by pushing the boundaries of what non-surgical treatments can offer. We are delighted to introduce our first Hybrid Injectable to market and believe its potential to offer immediate lift from hyaluronic acid with the lasting collagen stimulation associated with calcium hydroxyapatite may answer some of the multi-dimensional needs of ageing skin."

The evidence 
Significant clinical improvements have been demonstrated with HArmonyCa^TM with Lidocaine from baseline to subsequent follow up in a recent clinical study (N=162), with:^6§

•  86% of 85 treated regions among 48 patients⁶§|| showing clinically significant improvement
• 91.6% of patients registering an improvement in general appearance of facial areas treated with HArmonyCa^TM 6#§

HArmonyCa^TM has been clinically shown to deliver a low risk-benefit profile.⁶ In a post marketing clinical analysis of HArmonyCa^TM (N=162) commonly occurring side effects (erythema, swelling, pain, tenderness and itching) were manageable and self- limiting.^{6 ##} A full list of side-effects, contraindications, warnings and precautions can be found in the HArmonyCa^TM Instructions For Use manual.²

Training and education are an integral part of the Allergan Aesthetics offering. Allergan Aesthetics trains over 75,000 medical professionals around the world each year and Allergan will provide a range of in-person and virtual training packages to support medical professionals who wish to offer HArmonyCa™ with Lidocaine to their patients.

HArmonyCa™ was originally developed in Israel and has been commercially available in Brazil, Israel and Ukraine. Having now secured a CE mark, it is being launched across Europe and in select EEMEA countries. Allergan Aesthetics will continue to explore and work with appropriate regulatory authorities around the world to make HArmonyCa™ more widely available in the future.

Allergan Aesthetics is known for its leading filler range and as the company behind the world's number one brand of HA facial fillers, JUVÉDERM®.^14¶¶ HArmonyCa™ with Lidocaine is the newest addition to its growing aesthetics portfolio and represents AbbVie's commitment to investing in the future of the aesthetics market.

For more information please contact your local Allergan Aesthetics office or representative.

Notes to Editors

About Allergan Aesthetics 
At Allergan Aesthetics, an AbbVie company, we develop, manufacture, and market a portfolio of leading aesthetics brands and products. Our aesthetics portfolio includes dermal filler, body contouring, plastics, skin care, and more. Our goal is to consistently provide our customers with innovation, education, exceptional service, and a commitment to excellence, all with a personal touch. For more information, visit www.AllerganAesthetics.co.uk 

About AbbVie 
AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women's health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio.

Contact(s)

International Media: 
Karen Dennehy 
Director, Communications & Public Relations, International Brands, Allergan Aesthetics 
+44 7824 017 950

UK Media: 
Stacey Brazier 
Head of Communications & Public Relations, UK, Allergan Aesthetics 
Stacey.Brazier@allergan.com  
+44 7879 435 640

Footnotes:

HArmonyCa^TM with Lidocaine is referred to as HArmonyCa^TM throughout 
^* Online interviews completed by over 12,000 'aesthetically aware' 25-64-year-old women and men across 15 countries between July 14th to August 4th 2021. Funded by Allergan^13 
† Results derived from an animal model study comparing fillers^7  
§ A post marketing clinical follow up of safety and performance of HArmonyCaTM (N=162)^6 
|| Performance evaluation using the Lemperle Scale^6 
# Performance evaluation using the Global Aesthetic Improvement Scale^6 
**With CaHA collagen formation can last up to 12 months^3 
†† Results from a pre-clinical animal study of HArmonyCaTM with results demonstrated over 8 weeks^5 
§§ Results from a pre-clinical animal study of HArmonyCaTM with results demonstrated over 12 weeks^4 
|||| Performance evaluation using the 5-point Likert Scale User Satisfaction Questionnaire^6 
¶¶ Based on healthcare professional tracking market research, from over 1,000 healthcare professionals in the largest 13 aesthetic markets worldwide^{14  
##} In a post-marketing clinical analysis of HArmonyCa™ (N=162), one unrelated serious adverse event (AE) was reported and one AE required medical intervention due to material migration into the lips and over correction⁶

References

¹ De Boulle K, et. al. Dermatol Surg. 2013 Dec;39(12):1758-66. 
² Allergan Aesthetics. HArmonyCa^TM Lidocaine IFU. M032 V01. 2021. 
³ Gonzaga da Cunha M, et al. Surg Cosmet Dermatol. 2020;12:109–17. 
⁴ Allergan Aesthetics. Data on File. HArmonyCa^TM Lidocaine INT-HAR-2150036. Lift capacity. July 2021. 
⁵ Allergan Aesthetics. Data on File. HArmonyCa^TM Lidocaine INT-HAR-2150040. Collagen stimulation. July 2021. 
⁶ Allergan Aesthetics. Data on File. INT-HAR-2150007.HArmonyCa^TM. Clinical Study Report. April 2021. 
⁷ Hee C, et al. Dermatol Surg. 2015;41:S373–381. 
⁸ Lipko-Godlewska S, et al. J Cosmet Dermatol. 2021;14:169–178. 
⁹ Zerbinati N, Calligaro A. Clin Cosmet Investig Dermatol. 2018;11:29–35. 
¹⁰ Kahn DM, Shaw RB. Facial Plast Surg. 2010;26:350–355. 
¹¹ Swift A, et al. Aesthet Surg J. 2020;sjaa339. 
¹² Coleman SR, Grover R. Aesthet SurgJ. 2006;26:S4-S9. 
¹³ Consumer Beauty Insights Study 2021 - REF-83962 
¹⁴ Allergan. Unpublished Data. INT/0771/2016(2). JUVÉDERM^®, the world's leading brand of hyaluronic acid facial fillers. Feb 2019.