Galderma Receives FDA Approval for Restylane® Contour for Cheek Augmentation and Correction of Midface Contour Deficiencies

Galderma's first and only product in the U.S. to use proprietary XpresHAn Technology™ for the cheeks

FORT WORTH, Texas, June 29, 2021 /PRNewswire/ -- Galderma announced today the U.S. Food and Drug Administration (FDA) has approved Restylane^® Contour for cheek augmentation and correction of midface contour deficiencies in adults over the age of 21.¹ Restylane Contour, a new hyaluronic acid (HA) dermal filler, is Galderma's first and only product in the U.S. formulated with XpresHAn Technology™ for the cheeks. XpresHAn Technology™ uses a unique manufacturing process which creates a smooth, injectable gel that integrates into the skin for natural, dynamic expression in motion.^1-4

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Cheek filler searches have risen in popularity 218% from 2018-2020.⁵ Restylane Contour provides a treatment with high patient* satisfaction.^† 

"Cheeks are the cornerstone of the face, and focusing on natural contour and not just volume loss can result in a dynamic expression that amplifies their natural beauty.^1,6" said Dr. Leslie Baumann, M.D., a board-certified dermatologist in Miami and a lead investigator in the clinical trial of Restylane Contour. "Hyaluronic acid levels in the skin diminish as we age, causing the face to lose shape, while increasing the likelihood that wrinkles and folds will appear.^7,8"

"In the past, it was all about volume for the cheeks, but consumers today are looking for  natural-looking results, such as the dynamic expression provided by XpresHAn Technology™,^1-4" said Diane Gomez-Thinnes, Head of Galderma U.S. "Developed by leading innovators in the hyaluronic acid filler market, Restylane Contour delivers a treatment you can trust. While individual results may vary, 98% of Restylane Contour patients* were pleased with their result at 1 year.^9‡ The dynamic results truly speak for themselves."

The FDA approval of Restylane Contour is supported by data from a randomized, comparator-controlled, multi-center, pivotal Phase 3 study conducted at 15 centers across the United States.⁹ The study evaluated 270 patients* across two groups over 48 weeks. Group A compared the effectiveness and safety of Restylane Contour (n=142) versus a control comparator (n=68). Group B compared the injection of Restylane Contour with needle (n=60) and cannula devices (n=60) in the same patient* on each side of their face. Results showed that Restylane Contour is safe and effective for cheek augmentation and the correction of midface contour deficiencies. Patients* treated with Restylane Contour required less total volume injected to achieve optimal aesthetic results^§¶# compared to patients* treated with the comparator (4.26 mL versus 4.88 mL, respectively). In Group A, ≥76% of patients* treated with Restylane Contour were 'satisfied' with their cheeks compared to ≥73% treated with the comparator across all FACE-Q questions through Week 48.^‡ Among patients* in Group B, more than 91% were "satisfied" with their cheeks across all FACE-Q questions at all timepoints through Week 48.^†‡

In the Phase 3 study, Restylane Contour was well tolerated for cheek enhancement. The most commonly observed side effects for cheek injection were bruising, redness, swelling, pain, tenderness, and itching at the injection site. Most patients* (85%) did not experience any adverse events (AEs) related to treatment with Restylane Contour. There were no severe or late-onset AEs related to Restylane Contour treatment, and 93% of AEs related to treatment with Restylane Contour were mild in intensity (53/57), with four moderate AEs of bruising, pain and/or facial pain. Restylane Contour showed comparable efficacy and safety when injected with needles and cannula devices.^1,9

Outside of the U.S., XpresHAn Technology™ is known as OBT and Restylane Contour is marketed as Restylane Volyme, which received its CE-mark in 2010 and has been used to treat over 1.5 million patients worldwide to date.¹⁰

Availability of Restylane Contour
Galderma will work closely with its aesthetic injector partners to introduce Restylane Contour in respective practice locations across the country beginning this summer.

To learn more about Restylane Contour, visit RestylaneUSA.com.

About Galderma's Restylane Product Portfolio
The FDA approval of Restylane Contour adds to Galderma's growing 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.¹¹ 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).¹¹

About Galderma
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.

To earn exclusive rewards, bonuses and discounts on Galderma's aesthetic treatments, join the ASPIRE Rewards program. To learn more about ASPIRE, visit www.aspirerewards.com.

Follow Galderma on Instagram at @GaldermaAestheticsUSA.

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.

APPROVED USES
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.

*Patient=Clinical trial subject
† FACE-Q satisfaction with the cheek questionnaire
‡ FACE-Q rating of "very satisfied" or "somewhat satisfied" with questions
 § ≥1 grade improvement in midface fullness at 12 weeks     
 ¶ MMVS (Medicis Midface Volume Scale)
 # Post-hoc analysis data on the total amount of product needed to show an improvement in midface fullness 12 weeks after treatment

1. Restylane Contour. Instructions for Use. Fort Worth, TX: Galderma Laboratories, L.P., 2021.
2. Philipp-Dormston WG, Wong C, Schuster B, Larsson M, Podda M. Evaluating perceived naturalness of facial expression after fillers to the nasolabial folds and lower face with standardized video and photography. Dermatol Surg. 2018;44(6):826-832.
3. Segura S, Anthonioz L, Fuchez F, Herbage B. A complete range of hyaluronic acid filler with distinctive physical properties specifically designed for optimal tissue adaptations. J Drugs Dermatol. 2012;11(1Suppl):s5-s8.
4. Lundgren B, Sandkvist U, Bordier N, et al. Using a new photo scale to compare product integration of different hyaluronan-based fillers after injection in human ex vivo skin. J Drugs Dermatol. 2018;17(9):982-986.
5. Yelp. Yelp Economic Average Report. Q2 2020.
6. Fitzgerald R, Carqueville J, Yang P.T. An approach to structural facial rejuvenation with fillers in women. International Journal of Women's Dermatology. 2019; 5(01): 52-57.
7. Papakonstantinou E, Roth M, Karakiulakis G. Hyaluronic acid: A key molecule in skin aging. Dermatoendocrinol. 2012;4(3):253-258.
8. Tan M, Kontis TC. Midface volumization with injectable fillers. Facial Plast Surg Clin North Am. 2015 May;23(2):233-242.
9. Data on file. 43USV1704 Clinical Study Report. Fort Worth, TX: Galderma Laboratories, L.P., 2020.
10. Data on file. MA-47682. Restylane Volyme. Galderma Laboratories, L.P., 2020.
11. Data on file. MA-39680. Fort Worth, TX: Galderma Laboratories, L.P., 2019.

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SOURCE Galderma