Galderma (SIX: GALD), the pure-play dermatology category leader, today announced that the U.S. FDA has approved Restylane Contour for the correction of temple hollowing in patients over the age of 21.1,2 This builds on its previous approvals for cheek augmentation and midface contour deficiencies, helping injectors address volume loss across key structural areas.1-3
With the broadest Injectable Aesthetics portfolio in the industry, this follows the recent U.S. approval of Restylane Lyft for augmentation of the chin region, adding to its indications to treat the midface, facial folds and wrinkles, back of hands, and the chin.4,5 Together, these approvals demonstrate Galderma’s ongoing commitment to evolving the versatile Restylane portfolio to deliver personalized, natural-looking outcomes that meet diverse patient needs.1,4,6,7
The volume of the temples can diminish with age, which can disrupt facial balance and harmony, and contribute to a tired, sunken, and aged appearance.3,8,9 These facial changes can be accelerated in people undergoing medication-driven weight loss, a phenomenon which has increased rapidly in recent years resulting in a growing area of aesthetic need.3,8,9 Galderma is spearheading efforts to address these concerns, including with this latest approval for Restylane Contour, which provides a new option for increasing volume in the temples to help restore balance for a more refreshed, youthful look.1-3 With a dual-layer patent-pending technique leveraging both needle and cannula, Restylane Contour enables healthcare professionals to provide precise, customized, and safe product placement in line with each patient’s aesthetic goals.1-3 Restylane Contour is powered by OBT™/XpresHAn™ technology, which integrates into the skin and balances support and flexibility, to provide long-lasting, natural-looking results that move with facial expressions.1-3,6
|
“Despite the temples playing an important role in maintaining a youthful, balanced appearance, they are often overlooked as an aesthetic treatment area. I’m pleased to have a new treatment option that I can recommend to my patients to help restore youthful proportions by effectively improving temple hollowing. This latest approval for Restylane Contour, offering dual-depth injection flexibility, will help me deliver harmonious, natural-looking results across the midface and temples that suit my patients’ unique features.” |
The approval is based on clinical results showing that Restylane Contour improved temple hollowing compared with no treatment at three months, with results lasting for up to 18 months, and high investigator and patient (clinical trial participant) satisfaction:1,2
|
“This approval for Restylane Contour with an innovative injection technique is yet another demonstration of our ongoing commitment to ensuring our trusted products deliver what healthcare professionals need to meet diverse aesthetic goals. For example, as rates of medication-driven weight loss expand, we’re seeing greater need for treatments that can address associated facial volume changes. Restylane Contour for temples aligns with this rising demand, providing a natural and authentic way to restore harmony.” |
With over 30 years of innovation and more than 77 million treatments administered worldwide, Restylane remains highly relevant in addressing some of today’s most significant aesthetic trends and needs, from changes following medication-driven weight loss to growing concerns related to menopause and skin health.10-14 As patient expectations shift toward more effortless, always-on rejuvenation, Galderma’s new ‘Wake Up To Restylane’ campaign positions Restylane as an everyday natural beauty ally for the face and body, highlighting Galderma’s commitment to meeting emerging needs. Focused on the growing desire for natural, authentic results, the campaign underscores Restylane’s ability to deliver personalized outcomes that move naturally with expression, helping people look refreshed and feel confident in their skin.6,7,14,15
*Restylane Contour is known as Restylane Volyme™ in countries outside of the U.S.
**Spokesperson is a paid Galderma consultant
Important safety information
Restylane Contour is indicated for cheek augmentation and the correction of midface contour deficiencies in patients over the age of 21. Restylane Contour is also indicated for correction of temple hollowing in patients over the age of 21.
Restylane Contour contains traces of gram-positive bacterial protein and is contraindicated for patients with allergies to such material or for patients with severe allergies that have required in- hospital treatment. Restylane Contour should not be used by people with bleeding disorders, with hypersensitivity to amide-type local anesthetics, such as lidocaine, or by women who are pregnant or breastfeeding.
The most common side effects include bruising, redness, swelling, pain, tenderness, and itching at the injection site. Use at the site of skin sores, pimples, rashes, hives, cysts, or infection should be postponed until healing is complete. The safety or effectiveness of treatment in areas other than the cheek, midface or temple has not been established in controlled clinical studies.
Delayed-onset inflammation near the site of dermal filler injections is one of the known adverse events associated with dermal fillers, and cases have been reported to occur at the dermal filler treatment site following viral or bacterial illnesses or infections, vaccinations, or dental procedures. Typically, the reported inflammation was responsive to treatment or resolved on its own. Serious but rare side effects include delayed onset infections, recurrence of herpetic eruptions, superficial necrosis, and scarring at the injection site. Do not implant into blood vessels. Use with caution in patients recently treated with anticoagulant or platelet inhibitors to avoid bleeding and bruising.
Restylane Contour is only available through a licensed practitioner. Complete Instructions for Use are available at www.RestylaneUSA.com.
About the Restylane portfolio
Restylane hyaluronic acid injectables are designed differently to go beyond volumizing for natural-looking results.1,14,16 Our hyaluronic acid is exceptionally pure and our innovative manufacturing process preserves its biocompatibility while creating individual products designed for a specific purpose.17-19 Restylane’s unique technologies, NASHA HD™, NASHA™ and OBT™/XpresHAn™, are meaningfully designed to mimic the diverse range of facial structures and skin layers.5,14,16,20 With the highest G’ and highest flexibility, Restylane can provide structural support, natural expressions and a healthy glow.6,16,19-23 Trusted for almost three decades, our hyaluronic acid gels work in sync with your skin for natural looking results.14,24,25
About Galderma
Galderma (SIX: GALD) is the pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that span the full spectrum of the fast-growing dermatology market through Injectable Aesthetics, Dermatological Skincare and Therapeutic Dermatology. Since our foundation in 1981, we have dedicated our focus and passion to the human body’s largest organ – the skin – meeting individual consumer and patient needs with superior outcomes in partnership with healthcare professionals. Because we understand that the skin we are in shapes our lives, we are advancing dermatology for every skin story. For more information: www.galderma.com.
References