Galderma receives approval for Restylane® Vital™, Restylane® Lyft™, and Restylane® Lidocaine in China
- First approval for a class III medical device for improved skin appearance in China
- First introduction of the new product category “Skinboosters” in China
Lausanne, April 22, 2020 – Galderma announced that it has received three new approvals from the National Medical Products Administration of China, NMPA, with Restylane® Vital™, Restylane® Lidocaine and Restylane® Lyft™ Lidocaine, further expanding the Restylane portfolio in China.
Restylane Vital, a product to improve skin appearance, will be launched later this year in China. This will mark the first introduction of a Galderma Skinboosters product to this important market. Skinboosters is an entirely new category of aesthetic treatment for tired and/or dull-looking skin, with broad consumer appeal and significant commercial potential. Within this newly established category, Restylane Skinboosters remains the market leader in many countries.
Restylane Lidocaine and Restylane Lyft Lidocaine both contain an integrated local anesthetic, Lidocaine, to provide patients with a more comfortable treatment experience. As demonstrated in clinical studies1, Restylane Lidocaine and Restylane Lyft Lidocaine provide instant pain relief upon injection without affecting the well-established safety profile of Restylane.
Hyaluronic acid (HA) is a natural component of the skin that keeps it hydrated and soft. With age, or due to harsh environment, the hyaluronic acid content in the skin may decrease, and the skin may lose some of its elasticity and hydration. Restylane Vital utilizes a patented HA stabilization technology (NASHA™), delivering significant improvements in skin appearance. Research2 shows that 74% of consumers are concerned about tired or dull-looking skin. And among consumers who have already had aesthetic treatments, the second most common treatment goal is to improve skin quality and appearance.
"We have the broadest portfolio of fillers and Restylane Vital, an injectable HA treatment in our Skinboosters category, has been on the global market for over 15 years and has reached over 5.5 million treatments so far,” stated Alexandre Brennan, Global Business Unit Head Aesthetics, Galderma. "With our strong heritage of Restylane products we are very pleased to now be able to offer Skinboosters as well as Restylane Lidocaine and Restylane Lyft Lidocaine in China.”
The approval of Restylane Vital is the first in China for an imported class III medical device product to improve skin appearance. It was based on a multi-center, randomized, evaluator-blinded, split-hand, no treatment-controlled study3 evaluating the safety and efficacy of Restylane Vital in Chinese subjects. The study showed a statistically significant reduction of the severity of hand aging after treatment with Restylane Vital compared to the no treatment control at the primary endpoint. Restylane Vital restores the natural composition of the skin and boosts skin elasticity, reducing skin roughness. The skin becomes smooth and hydrated for a refreshed and healthy look.
The approvals of Restylane Lidocaine and Restylane Lyft Lidocaine were based on two multi-center studies1, where subjects received Restylane Lidocaine or Restylane Lyft Lidocaine in one nasolabial fold and a product without Lidocaine, Restylane or Restylane Lyft, in the opposite nasolabial fold, as randomly assigned and with treatment masked both to the subject and the evaluating investigator. These studies showed consistently less pain on the side treated with Restylane Lidocaine or Restylane Lyft Lidocaine while retaining the excellent effectiveness in wrinkle reduction achieved with the original Restylane or Restylane Lyft products. Restylane Lidocaine and Restylane Lyft Lidocaine, with built in pain relief can lead to a more positive experience for patients and improve efficiency for our customers as topical pain alleviation with creams requires about one hour of induction time in order to achieve full effect.
“The Chinese Aesthetic market will continue to rapidly evolve over the next 10 years,” said Olivia Brown, General Manager, Greater China Region for Galderma. “The market will be driven by the introduction of technically advanced products, minimally invasive treatments and sustained consumer demand. Clear winners will be those who offer safe and differentiated products, superior results and lifetime value to patients through repeated treatments.”
With 40 million treatments worldwide and counting, the Restylane family of HA dermal fillers is the broadest portfolio of dermal fillers in the world. To learn more about the Restylane family of products, visit www.galderma.com.
About Skinboosters, Restylane® Vital™, Restylane® Lidocaine and Restylane® Lyft™ Lidocaine
Over the past 15 years, Restylane® Skinboosters have been used in 5.5 million treatments globally and the Restylane® range of products have been used in over 40 million aesthetic treatments worldwide.
Restylane® Vital™ uses an HA stabilization technology (NASHA™), delivering significant improvements in skin appearance for up to 15 months according to a recent clinical trial in China. Restylane Skinboosters are a versatile and effective solution for achieving improvements of skin appearance in the face, neck and décolletage and on the hands.
Restylane® Lidocaine and Restylane® Lyft™ Lidocaine, contain an integrated local anesthetic, Lidocaine, to provide patients with a more comfortable treatment experience. This extended range of the product portfolio with built in pain relief, helps meet the market demand around the globe.
Galderma, the world's largest independent global dermatology company, was created in 1981 and is now present in over 100 countries with an extensive product portfolio of prescription medicines, aesthetic solutions and consumer care products. The company partners with health care practitioners around the world to meet the skin health needs of people throughout their lifetime. Galderma is a leader in research and development of scientifically-defined and medically-proven solutions for the skin. For more information, please visit www.galderma.com.
Isabella Laihorinne Smedh
PR & Communications, Galderma
+46 76 1811713
1 Data on file
2 Source: ACT Market Research 2019
3 Data on file