Galderma, Announces

Galderma Announces Regulatory Approval for Restylane? SHAYPE?, a New Hyaluronic Acid Injectable Designed for Augmenting the Chin Region

22.01.2024 - 08:21:00

Business Wire India
  • Restylane® SHAYPE™ is the firmest hyaluronic acid (HA) injectable available,1,2* designed for deep injection onto bone2 and providing a bone-mimicking effect to shape the lower face
  • Powered by new NASHA HD™ technology, Restylane® SHAYPE™ is the latest addition to the Restylane® portfolio, the world’s most diverse range of HA fillers
  SHAYPE™, a hyaluronic acid (HA) injectable designed for temporary augmentation of the chin region.2 Engineered to build and shape on bone with deep injection for a bone-mimicking effect,1,2,3,4† Restylane® SHAYPE™ will be available in Canada as of February 2024.

 

The chin is a critical component of overall appearance that influences the balance of facial proportions, profile, and shape.5,6,7,8 Genetics and age can impact overall chin definition,6,9 which may cause the appearance of a double chin, or “weak chin.” For decades, there has been heavy reliance on implants to create structure in the lower face, with no non-surgical options available offering qualities close to an implant.

 

Powered by new NASHA HD™ technology from Galderma,4 Restylane® SHAYPE™ has the highest G’ (“G prime”) of the Restylane® range.1,11 The firmest HA gel available on the market,1,2* Restylane® SHAYPE™ allows aesthetic injectors to shape, project and elongate the chin2,3 for natural-looking results from any angle.3‡ As a minimally modified and particularly firm HA gel,10 Restylane® SHAYPE™ is the injectable closest to the HA naturally found in skin10 and can be readily reversed.2,12,13

 

“Restylane® SHAYPE™ is the next generation in HA, going beyond currently available options for chin augmentation. Developed with leading experts, this innovative breakthrough has a unique ability to create the strength and support needed for a bone-mimicking effect. This makes Restylane® SHAYPE™ an ideal choice for lower face shaping, offering durable, natural-looking results for up to 12 months without retreatment.”

 

BALDO SCASSELLATI SFORZOLINI, M.D., Ph.D.
GLOBAL HEAD OF R&D
GALDERMA

 

In a pivotal 12-month study conducted at nine sites across Canada, 91% of patients agreed they still had aesthetic improvements at 12 months, and 84% of patients would agree to be treated with Restylane® SHAYPE™ again. Furthermore, up to 97% of patients would recommend treatment with Restylane® SHAYPE™ to a friend and 95% of patients felt their results looked natural.3

 

“A product with a significant ability to create a bone-mimicking effect without the downtime of surgery has long been an unmet need, highlighted by the community of plastic surgeons, dermatologists, and aesthetic injectors all over the world. The development of the ideal gel required a significant increase in firmness to create the strength and support needed to shape the lower face. Now, through meticulous clinical evaluation, Galderma has achieved the development of a safe and effective HA injectable for chin remodeling.”

 

DR. ANDREAS NIKOLIS, M.D., Ph.D., FRCSC, BOARD-CERTIFIED PLASTIC SURGEON
PRINCIPAL INVESTIGATOR, RESTYLANE® SHAYPE™ PIVOTAL STUDY
MONTREAL, CANADA

 

Other regulatory reviews around the world are ongoing, and Galderma is working to bring this latest innovation to as many countries as possible.

 

About Galderma’s RESTYLANE® portfolio
RESTYLANE® is produced using the NASHA HD™ technology and is the original hyaluronic acid filler, with over 27 years of clinical experience and over 65 million treatments worldwide. NASHA® and OBT™ are complementary technologies that make RESTYLANE® the world’s most diverse range of fillers, for any and every look.

 

About Galderma
Galderma is the emerging pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that span the full spectrum of the fast-growing dermatology market though Injectable Aesthetics, Dermatological Skincare and Therapeutic Dermatology. Since our foundation in 1981, we have dedicated our focus and passion to the human body’s largest organ – the skin – meeting individual consumer and patient needs with superior outcomes in partnership with healthcare professionals. Because we understand that the skin we are in shapes our lives, we are advancing dermatology for every skin story. For more information: www.galderma.com.

 

References

1 Galderma. Data on file. MA-56724. 2023. Global rheology data (xStrain and G' including Restylane® SHAYPE™).

2 Restylane® SHAYPE™ IFU. IFU-0103. August 2023.

3 Galderma. Data on file. MA-53870. 2023. Restylane® SHAYPE™ 43BBJ2001 Clinical Study Report.

4 Galderma. Data on file. MA-56848. 2023. Technical data for Restylane® SHAYPE™.

5 Braz A, Eduardo CCP. Indian J Plast Surg. 2020;53(2):207–18.

6 Schmid PM. Advances in Cosmetic Surgery. 2019;2(1):11–21.

7 Gewargis J, Swaminathan V. J Aesthet Nurse; 2021:10(8);1–9.

8 Galderma. Data on file. 2022. AART Methodology Comprehensive Training Deck.

9 Sykes JM, Fitzgerald R. Facial Plast Surg. 2016;32(5):507–12.

10 Galderma. Data on file. MA-58650. 2023. Degree of modification of HA fillers.

11 Galderma. Data on file. MA-34483. 2023. xStrain and G' (US).

12 Paap MK, Silkiss RZ. Plast Aesthet Res. 2020;7:36.

13 Jung H. Arch Plast Surg. 2020;47(4):297–300.

† The highest G' of the Restylane® range, a deep (supraperiosteal) injection depth and indication for chin augmentation together mean Restylane® SHAYPE™ can achieve a bone-mimicking effect.

‡ Patients could receive a touch-up at Month 1.

* Based on the products marketed in Canada as of December 2023.

 

 

 
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