Pharma Focus Asia

Galderma Has Received Regulatory Approval for Restylane® SHAYPE™, a Novel Hyaluronic Acid Injectable Designed for Enhancing the Chin Region

Monday, January 22, 2024

Galderma, a leading player in the dermatology industry, has recently obtained approval from Health Canada for its latest hyaluronic acid (HA) injectable, Restylane® SHAYPE™. This innovative product is specifically designed for temporary chin augmentation, addressing concerns related to chin definition and facial balance. The approval paves the way for the availability of Restylane® SHAYPE™ in Canada starting February 2024.

The chin is a critical aspect of overall facial appearance, influencing factors such as facial proportions, profile, and shape. Genetic factors and the aging process can impact chin definition, resulting in issues such as a double chin or a "weak chin." Traditionally, surgical implants have been the conventional solution for enhancing lower face structure, with limited non-surgical alternatives.

Restylane® SHAYPE™, powered by Galderma's new NASHA HD™ technology, features the highest G' ("G prime") in the Restylane® range. As the firmest HA gel currently available, it enables aesthetic injectors to shape, project, and elongate the chin for natural-looking results from any angle. Notably, Restylane® SHAYPE™ is minimally modified, closely resembling the natural HA found in the skin, and can be easily reversed.

In a pivotal 12-month study conducted at multiple sites in Canada, 91% of patients reported sustained aesthetic improvements, with 84% expressing willingness to undergo Restylane® SHAYPE™ treatment again. Impressively, up to 97% of patients would recommend the treatment to others, and 95% felt that their results appeared natural.

Dr. Baldo Scassellati Sforzolini, Global Head of R&D at Galderma, emphasized that Restylane® SHAYPE™ represents the next generation in HA, surpassing existing options for chin augmentation. The product's unique ability to create a bone-mimicking effect makes it an ideal choice for lower face shaping, providing long-lasting, natural-looking results for up to 12 months without the need for retreatment.

Dr. Andreas Nikolis, Principal Investigator of the Restylane® SHAYPE™ pivotal study, noted the significant demand for a product capable of mimicking bone effects without surgical downtime. Galderma's meticulous clinical evaluation has resulted in the development of a safe and effective HA injectable for chin remodeling.

Galderma is actively pursuing regulatory approvals in other countries, with the goal of introducing this groundbreaking innovation to a global audience. The RESTYLANE® portfolio, produced using NASHA HD™ technology, represents over 27 years of clinical experience and has been utilized in over 65 million treatments worldwide, making it the most diverse range of fillers for various aesthetic needs.

 

Source: businesswire.com

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