Restylane Defyne and Refyne expand the company’s portfolio to four products in the Japanese market, designed for facial wrinkle correction.
Galderma has launched Restylane Defyne and Restylane Refyne in Japan, marking the first time Optimal Balance Technology (OBT) hyaluronic acid injectables have been approved and made available in the Japanese market.
The products are designed for injection into the mid-to-deep dermis for correction of moderate to severe facial wrinkles and folds. Both products leverage Galderma’s proprietary OBT technology, which is designed to move in harmony with facial expressions while maintaining shape and lift.
Restylane Refyne offers a flexible gel for delicate, highly expressive areas, while Restylane Defyne provides support for areas such as the jawline and deeper facial folds.Â
Expanded Product Portfolio
The launch expands Galderma’s Restylane portfolio in Japan to four products. Refyne and Defyne join existing NASHA-powered products Restylane Classyc and Restylane Lyft. This range enables clinicians to address diverse patient needs, from soft, flexible formulations for fine lines to firmer gels for contouring and support.
“The introduction of OBT technology to Japan is a significant milestone not only for clinicians but for the region’s aesthetic landscape as a whole. By combining the power of both NASHA and OBT within the Restylane portfolio in Japan, physicians can tailor treatments more precisely than ever before,” says Dr Stephanie Lam, plastic surgeon at Central Health Medical Practice in Hong Kong, in a release.
Clinical Trial Results
The approvals were based on two pivotal, double-blinded, randomized, active-controlled phase III studies investigating the products in 171 and 162 subjects, respectively. Both products met study endpoints, demonstrating clinically meaningful improvement in wrinkle severity for up to 12 months, with most patients reporting at least a 1-grade improvement in self-assessment scores after six weeks.
“The approval of Restylane Defyne and Refyne—the first OBT HA injectables ever authorized in Japan—is a landmark moment for Galderma in the region. A decade after NASHA’s introduction to this market, we are proud to now offer a fully rounded Restylane portfolio that gives healthcare professionals even more precision and flexibility to meet the needs of their patients,” says Hon Keong Choo, head of JPAC region at Galderma, in a release.
The Restylane brand has been used in more than 77 million treatments worldwide over 30 years. The arrival of OBT technology in Japan aligns the market more closely with global Restylane availability, according to the company.
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