FDA approves Restylane products for treating nasolabial folds

Galderma announced it has received FDA approval of two new Restylane products for the treatment of nasolabial folds in patients over the age of 21.

The agency approved Restylane Refyne for moderate-to-severe facial wrinkles and folds and Restylane Defyne for treating moderate-to-severe, deep facial wrinkles and folds. The gels have been shown to maintain effectiveness for treating nasolabial folds for up to 12 months and are manufactured with XpresHAn technology, which customizes the degree of hyaluronic acid crosslinking in each product to allow a range of flexibly and support, according to a press release.

“Even with current approved options, many of my patients are still looking for different solutions to treat their laugh lines,” Steven Fagien, MD, Boca Raton, Florida-based oculoplastic surgeon and Restylane Refyne clinical investigator, stated in the release. “These new products are flexible and are designed to meet different patient needs. I am excited to offer these next-generation hyaluronic acid dermal fillers in my practice.”

The approval was based on two double-blind, randomized phase 3 investigating involving 171 patients for Restylane Refyne and 162 patients for Restylane Defyne, to measure safety and effectiveness. The products met primary endpoints, showing a clinically meaningful improvement in wrinkle severity up to 12 months in the majority of patients, according to the release.

Researchers reported that 79% of patients treated with Restylane Refyne and 77% of patients treated with Restylane Defyne had at least a 1-grade improvement on the Wrinkle Severity Rating Scale after 6 weeks. Most patients reported at least a 1-grade improvement on self-assessments of wrinkle severity for either treatment after 6 weeks, according to the release.

After initial treatment, injection site responses, including redness, swelling, bruising, lump/bump formation, pain/tenderness, were predominantly mild or moderate in intensity and temporary, with a duration of one or two weeks, and were similar for the Restylane products, the release reported.

Mitch Goldman

“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,” Mitch Goldman, MD, a San Diego-based dermatologist, stated in the release. “The introduction of these next-generation [hyaluronic acid] dermal fillers with XpresHAn Technology has the potential to change my patients’ views on fillers.”

Reference: www.galaderma.com