Galderma, the world’s largest independent dermatology company, has recently marked the 25th anniversary of RESTYLANE®. Since launching in Europe in 1996 and becoming the first hyaluronic acid filler approved by the U.S. Food and Drug Administration (FDA) in 2003, RESTYLANE has celebrated many milestones across the globe. 1,2 Over the last 25 years, RESTYLANE has continued to surpass expectations as a pioneer for innovation, driving the future of aesthetics forward by pushing beyond the status quo to restore, enhance and refresh a youthful-looking appearance.
Now, in its 25th year, the RESTYLANE portfolio continues to grow and expand. Since RESTYLANE’s U.S. FDA approval in 2003, there have been 13 dermal filler product approvals and launches. The RESTYLANE portfolio offers a diverse range of fillers by using two complementary gel technologies, NASHA™ and XpresHAn™ (globally referred to as the OBT technology (Optimal Balance Technology)), to provide personalized, natural-looking results that deliver high patient satisfaction.3
In February, the FDA approved RESTYLANE DEFYNE® for the augmentation and correction of mild to moderate chin retrusion for adults over the age of 21.4 In June, RESTYLANE added a new product to the portfolio, RESTYLANE CONTOUR®, for cheek augmentation and correction of midface contour deficiencies in adults over the age of 21, becoming the first and only product in the U.S. to use proprietary XpresHAn Technology™ for the cheeks.5 These approvals mark major successes for the industry-standard filler.
With more than 50 million administered treatments and counting, this 25-year milestone marks a continuation of excellence and trust for RESTYLANE. Galderma continues to innovate and create dynamic products with natural-looking results, to ensure aesthetics providers and their customers have confidence in the brand.
“The depth of experience from RESTYLANE over the last 25 years has enabled us to build upon our expertise to innovate and develop new formulations and treatments,” said Flemming Ørnskov, M.D., MPH, Chief Executive Officer at Galderma. “With over 30 ongoing pipeline projects in aesthetics alone, we will continue to enhance our diverse and broad portfolio of sophisticated brands to advance dermatology for every skin story.”
About Galderma’s Restylane Product Portfolio
With over 50 million treatments worldwide and counting, the Restylane family of HA dermal fillers is the most diverse and broadest portfolio of dermal fillers in the U.S.6 These products help smooth facial wrinkles and folds, such as smile lines (Restylane L, Restylane Refyne, Restylane Defyne and Restylane Lyft with Lidocaine), augment and correct mild to moderate chin retrusion (Restylane Defyne), create fuller and more accentuated lips (Restylane Silk, Restylane-L and Restylane Kysse), add lift and volume to the cheeks and back of the hands (Restylane Lyft with Lidocaine), and augment cheeks and correct midface contour deficiencies (Restylane Contour).6
Galderma is the world’s largest independent dermatology company, present in approximately 100 countries. Since our inception in 1981, we have been driven by a complete dedication to dermatology. We deliver an innovative, science-based portfolio of sophisticated brands and services across Aesthetics, Consumer Care and Prescription Medicine. Focused on the needs of consumers and patients, we work in partnership with healthcare professionals to ensure superior outcomes. Because we understand that the skin we’re in shapes our life stories, we are advancing dermatology for every skin story. For more information: www.galderma.com/us.
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IMPORTANT SAFETY INFORMATION
The Restylane family of products are indicated for patients over the age of 21, and includes Restylane®, Restylane-L®, Restylane® Lyft with Lidocaine, Restylane® Silk, Restylane® Kysse, Restylane® Refyne, Restylane® Defyne, and Restylane® Contour.
Restylane® and Restylane–L® are for mid-to-deep injection into the facial tissue for the correction of moderate to severe facial wrinkles and folds, such as nasolabial folds. Restylane® and Restylane-L® are also indicated for injection into the lips.
Restylane® Lyft with Lidocaine is for deep implantation into the facial tissue for the correction of moderate to severe facial wrinkles and folds, such as nasolabial folds and for cheek augmentation and for the correction of age-related midface contour deficiencies. Restylane® Lyft with Lidocaine is also indicated for injection into the dorsal hand to correct volume loss.
Restylane® Silk is for lip augmentation and for correction of perioral wrinkles.
Restylane® Kysse is for lip augmentation and for correction of upper perioral wrinkles.
Restylane® Refyne is for mid-to-deep injection into the facial tissue for the correction of moderate to severe facial wrinkles and folds, such as nasolabial folds.
Restylane® Defyne is for mid-to-deep injection into the facial tissue for the correction of moderate to severe deep facial wrinkles and folds, such as nasolabial folds. Restylane® Defyne is also indicated for injection into the mid-to deep dermis (subcutaneous and/or supraperiosteal) for augmentation of the chin region to improve the chin profile in patients with mild to moderate chin retrusion.
Restylane® Contour is for cheek augmentation and for the correction of midface contour deficiencies.
Do not use if you have severe allergies with a history of severe reactions (anaphylaxis), are allergic to lidocaine or gram-positive bacterial proteins used to make hyaluronic acid, prone to bleeding, or have a bleeding disorder. The safety of use while pregnant or breastfeeding has not been studied. Tell your doctor if you have a history of scarring or pigmentation disorders as these side effects can occur with hyaluronic acid fillers. Tell your doctor if you are planning other cosmetic treatments (i.e., lasers and chemical peels) as there is a possible risk of inflammation at the injection site.
Tell your doctor if you’re taking medications that lower your body’s immune response or affect bleeding, such as aspirin or warfarin, as these medications may increase the risk of bruising or bleeding at the gel injection site. Using these products on gel injection sites with skin sores, pimples, rashes, hives, cysts, or infections should be postponed until healing is complete.
The most common side effects are swelling, redness, pain, bruising, headache, tenderness, lump formation, itching at the injection site, and impaired hand function. Serious but rare side effects include delayed onset infections, recurrence of herpetic eruptions, and superficial necrosis at the injection site. The risk of unintentional injection into a blood vessel is small but can occur and could result in serious complications, which may be permanent including, vision abnormalities, blindness, stroke, temporary scabs, or permanent scarring of the skin. As with all skin injection procedures, there is a risk of infection.
To report a side effect with any Restylane® product, please call Galderma Laboratories, L.P. at 1-855-425-8722.
To learn more about serious but rare side effects and full Important Safety Information, visit www.RestylaneUSA.com.
© 2021 Galderma Laboratories, L.P. All trademarks are the property of their respective owners.
- FDA. Summary of safety and effectiveness data. Available at: https://www.accessdata.fda.gov/cdrh_docs/pdf2/P020023b.pdf Last accessed September 2021.
- Restylane SFDA Certificate. 2008.
- Data on file. Fort Worth, TX: Galderma Laboratories, L.P.
- Restylane DEFYNE. Instructions for Use. Fort Worth, TX: Galderma Laboratories, L.P., 2021.
- Restylane CONTOUR. Instructions for Use. Fort Worth, TX: Galderma Laboratories, L.P., 2021.
- Data on file. MA-39680. Fort Worth, TX: Galderma Laboratories, L.P., 2019.