Galderma a global leader focused on medical solutions in skin health recently announced that it has received U.S. Food and Drug Administration (FDA) approval for two new products for the treatment of nasolabial folds (NLF) or laugh lines.”
Restylane Refyne was approved for the treatment of moderate to severe facial wrinkles and folds and Restylane Defyne for the treatment of moderate to severe deep facial wrinkles and folds.
Unlike other fillers that are already on the market Restylane Defyne and Restylane Refyne incorporate a special XpresHAn technology deeming these products as next-generation hyaluronic acid fillers.
“Now that Refyne and Defyne are approved for use in the United States we can offer the most cutting-edge products to benefit patients here in DC Maryland and Virginia” said Dr. Maryam Nazamzadeh.
“I look forward to their release in 2017!”
The XpresHAn technology allows for the product to move within the face as facial expressions are made to prevent a fake injected or unnatural look.
Even with current approved options many of my patients are still looking for different solutions to treat their laugh lines said Boca Raton-based oculoplastic surgeon and Restylane Refyne clinical investigator Steven Fagien MD.
These new products are flexible and are designed to meet different patient needs. I am excited to offer these next-generation hyaluronic acid (HA) dermal fillers in my practice.
Restylane Refyne and Restylane Defyne are the latest FDA-approved advancements in HA dermal fillers and align with Galderma’s mission to help individuals achieve natural-looking results through treatments with a long-standing history of proven safety and efficacy said Kelly Huang PhD – VP & General Manager of the U.S. Aesthetic and Corrective business of Galderma.
We saw an opportunity to address a common concern for patients who have not yet tried a dermal filler by designing gels that provide natural-looking results. With these new brands the Restylane family of products now represents the broadest offering of HA dermal fillers in the U.S.
The FDA approval was based on two pivotal double-blinded randomized active-controlled Phase 3 studies investigating Restylane Refyne and Restylane Defyne (involving 171 and 162 subjects respectively) to evaluate their safety and effectiveness.
In both studies Restylane Refyne and Restylane Defyne met the studies endpoints with both products showing a clinically meaningful improvement in wrinkle severity for up to 12 months in the majority of patients.
Study investigators used the Wrinkle Severity Rating Scale (WSRS) a validated 5-point measure of the size and depth of the wrinkles with grade 1 defined as absence of wrinkles and grade 5 as extremely deep and long wrinkles.
Investigators reported that 79 percent of Restylane Refyne subjects and 77 percent of Restylane Defyne subjects had at least a 1-grade improvement on the WSRS after six weeks.
Subjects also performed self-assessments (SSA) of wrinkle severity with most subjects reporting at least a one-grade improvement in SSA scores with Restylane Refyne and with Restylane Defyne after six weeks.
Many of my patients are interested to learn about the latest products that can help them achieve natural-looking results but are oftentimes unsure about starting dermal fillers said San Diego-based board-certified dermatologist Mitch Goldman MD.
The introduction of these next-generation HA dermal fillers with XpresHAn Technology has the potential to change my patientsﾉￛﾪ views on fillers. Restylane Refyne and Restylane Defyne provide options for patients who want to make sure they can achieve results that provide options for patients who want to make sure they can achieve natural-looking results which is a key need my patients express every day.
After initial treatment injection site responses (redness swelling bruising lump/bump formation pain/tenderness) were predominantly mild or moderate in intensity temporary (typically with a duration of one to two weeks) and similar for the Restylane products.
