Pharmaceutical company Galderma has secured European Union approval under the Medical Device Regulation for Restylane Shaype for chin augmentation.
Powered by NASHA HD technology, the injectable is indicated for deep injection to build and shape on bone. According to Galerma, it is the first bone-mimicking hyaluronic acid (HA) injectable for facial shaping, designed to provide natural-looking structural enhancement without surgery.
The approval marks the latest addition to the company’s Restylane portfolio of HA injectables.
Baldo Sforzolini, global head of research and development at Galderma, commented, “The EU approval of Restylane Shaype represents an important regulatory milestone for Galderma and for injectable aesthetics more broadly. With approvals now spanning Europe, Canada, and Brazil, this first-and-only HA shaper is a valuable new addition to the overall aesthetic landscape, and to the Restylane portfolio, expanding clinicians’ ability to address structural concerns in ways that traditional HA fillers are not designed to. It reflects the strength of our clinical development capabilities and our commitment to delivering innovative, science-based solutions that respond to the increasing global demand for facial balancing.”