Galderma gets FDA nod to market Restylane Lyft with lidocaine for age related volume loss in cheek area.
Previously marketed as Perlane-L, Restylane Lyft is an injectable gel used to increase volume and smoothen wrinkles on the face.
Restylane Lyft with lidocaine is indicated for the correction of moderate to severe facial folds and wrinkles, such as nasolabial folds, as well as for subcutaneous to supraperiosteal implantation for cheek augmentation and correction of age-related midface contour deficiencies in these patients.
The company said that with this new indication, Restylane Lyft is the first and only FDA approved filler indicated to provide fullness to the midface area (cheeks) and to correct and smooth the nasolabial folds.
Galderma Aesthetic and Corrective Business Unit vice-president and general manager Kelly Huang said: "With more than 15 years of proven safety data and approximately 6 million treatments worldwide, Restylane Lyft is a trusted, safe and effective product and we are proud to be able to expand our offering to healthcare providers and consumers in the US."
With the approval, Restylane Lyft now joins Restylane, which is indicated to correct and smooth smile lines as well as to augment the lips, and Restylane Silk, the first and only treatment that is approved for lip enhancement and to treat wrinkles and lines around the mouth.
In a clinical trial which included 200 patients, the investigators observed that 88.7% of patients treated with Restylane Lyft showed an improvement in fullness in the right and left midface areas at two months, and more than half maintained improvement for 12 months.