Galderma Launches Restylane Silk for Lip Enhancement and Treatment of Perioral Lines
Galderma launched Restylane® Silk, the first and only dermal filler FDA approved for lip enhancement and the treatment of wrinkles and lines around the mouth in people over the age of 21. Restylane Silk is a smooth gel designed to restore natural youthful definition and symmetry to the lip and mouth area.
"We are proud to announce the launch of Restylane Silk, the first and only product specifically designed to treat the lips and lines around the mouth," said Stuart Raetzman, Chief Executive Officer of Galderma Laboratories, L.P, and Senior Vice President North America. "There is strong market interest for aesthetic products that can help address the signs of aging in the smile area without resulting in an artificial or "overdone" look, and we are pleased that Restylane Silk will satisfy this need for healthcare professionals and consumers in the US"
"Many of my patients want to address wrinkles in the lip and the vertical "barcode" lines that appear around the mouth with age, but want a natural look without the extra volume," said Doris Day, MD, NYC dermatologist. "The availability of Restylane Silk presents a new option for these patients that not only helps smooth wrinkles and lines, but also softly restores lip shape and enhances definition without over-plumping."
In a clinical study involving 221 patients, investigators observed that 77 percent of patients treated with Restylane Silk showed an improvement in lip fullness eight weeks after treatment and 59 percent of treated patients maintained lip fullness six months after treatmet, according to the company.
In the same study, 98 percent of patients treated with Restylane Silk reported a visible improvement in the fullness of their lips 14 days after injection and 76 percent reported that they still had lip improvement at six months following injection.
"The lip and perioral area is the second most common treatment area on the face, yet – until the availability of Restylane Silk – there has not been an FDA approved filler that has been able to effectively enhance this area with truly natural-looking results," said Kenneth Beer, MD, Director of Kenneth Beer MD PA Cosmetic, Surgical and General Dermatology in Palm Beach, Florida and an investigator in the Restylane Silk Phase III registration trial. "Restylane Silk is an exciting advancement on safe, effective and proven Restylane technology that was engineered specifically to treat the sensitive and delicate area in the lips and around the mouth. The clinical results we observed from the Restylane Silk trial demonstrated significant improvements in lip fullness, the smoothing of wrinkles around the mouth and showed extremely high levels of patient satisfaction."
Restylane Silk is administered by a physician or qualified healthcare professional. The product is injected into a patient's lip and/or area around the mouth in one or two sessions as needed and the process typically takes less than one hour. In the clinical study, the results of Restylane Silk lasted approximately six months following treatment. The most common side effects observed following treatment with Restylane Silk were swelling, tenderness, bruising, pain, and redness. The majority of these side effects were mild and decreased in severity within two to seven days. These side effects have also been observed in other lip enhancement clinical trials.
For more information about Restylane Silk, visit www.RestylaneSilk.com.