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Devices Dermatology FDA

 News Release - May 5, 2020

Galderma Receives FDA Approval For Restylane(R) Kysse, A New Hyaluronic Acid (HA) Filler Specifically Designed And Indicated To Add Fullness To The Lips And Help Smooth The Wrinkles Above The Mouth

FORT WORTH, Texas, May 5, 2020 -- (Healthcare Sales & Marketing Network) -- Galderma announces that the U.S. Food and Drug Administration (FDA) has approved Restylane® Kysse for lip augmentation and the correction of upper perioral rhytids (wrinkles around upper lips) in adults over the age of 21.1 Restylane Kysse is the first hyaluronic acid (HA) filler specifically indicated for the lips using XpresHAn Technology™ (pronounced ex-'spre-shan') globally referred to as the OBT technology (Optimal Balance Technology). Restylane Kysse is proven to last for up to 1 year1,2 with high levels of patient satisfaction for people with lips that have changed due to the aging process or for those seeking natural-looking, fuller lips.3

"Restylane Kysse is a new lip filler that offers key attributes both providers and their patients desire in a lip injection – high satisfaction, consistent results, and a proven clinical-safety profile," said Alisa Lask, General Manager and Vice President of the U.S. Aesthetic Business at Galderma.3,4,5 "We are confident that Restylane Kysse will become a leading lip filler in the dynamic U.S. market."

XpresHAn Technology™ products have demonstrated natural-looking results for patients with dynamic facial wrinkles.6 Restylane Kysse uses this technology to provide high levels of patient improvement* with 78% of trial patients reporting they were still satisfied with their results after 1 year.3 A lower amount of Restylane Kysse (1.82 mL) was needed to show an improvement in lip fullness** compared to the comparator (2.24 mL) in the Phase 3 trial supporting approval.3 Restylane Kysse was shown to be both safe and well-tolerated.4 It contains lidocaine, a medication used to numb the area to decrease pain and reduce discomfort associated with injections in the lip area.1

"Restylane Kysse is a game changer with a formulation specifically designed to provide excellent outcomes in the lips," said Dr. Melanie Palm, board-certified dermatologist and cosmetic surgeon in San Diego, CA and a clinical investigator in the Restylane Kysse phase 3 trial. "This new approval enables me to provide natural-looking results for my patients' lips that are apparent when they speak, smile or even kiss." 3,4

With over 40 million treatments worldwide and counting, the Restylane® family of HA dermal fillers is the broadest portfolio of dermal fillers in the world.5 The portfolio of products help to smooth facial wrinkles and folds, such as smile lines (Restylane®L, Restylane® Refyne, Restylane® Defyne and Restylane® Lyft with Lidocaine), create fuller and more accentuated lips (Restylane® Silk, Restylane®-L and Restylane® Kysse), and add lift and volume to the cheeks and the back of the hands (Restylane® Lyft with Lidocaine).5

We are working to determine the appropriate launch timing and availability for Restylane Kysse. The health and safety of aesthetic providers, patients and Galderma employees is our utmost priority and will continue to be. To learn more about the Restylane Kysse and the Restylane family of products, visit www.RestylaneUSA.com.

About Galderma

Galderma, the world's largest independent global dermatology company, was created in 1981 and is now present in over 100 countries with an extensive product portfolio of prescription medicines, aesthetic solutions and consumer care products. The company partners with health care practitioners around the world to meet the skin health needs of people throughout their lifetime. Galderma is a leader in research and development of scientifically-defined and medically-proven solutions for the skin. For more information, please visit 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.

RESTYLANE FAMILY 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® Refyne, Restylane® Defyne and Restylane® Kysse.

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.

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.

©2020 Galderma Laboratories, L.P. All Rights Reserved. All trademarks are the property of their respective owners.

* GAIS (Global Aesthetic Improvement Scale)

** MLFS (Medicis lip fullness scale)

1 Restylane Kysse. Instructions for Use. Galderma Laboratories, L.P., 2020.

2 Hilton S, Gerhard S, Berg AK, Samuelson U, Wong C. Randomized, Evaluator-Blinded Study Comparing Safety and Effect of Two Hyaluronic Acid Gels for Lip Enhancement. Dermatol Surg. 2018;44(2):261-269

3 Data on file. 43USK1701 Clinical Study Report. Fort Worth, TX: Galderma Laboratories, L.P., 2019.

4 Data on File. 05DF1807 Clinical Study Report. Fort Worth, TX: Galderma Laboratories, L.P., 2020.

5 Restylane. Restylane Heritage. https://www.restylane.com/en/heritage. Accessed March 20, 2020.

6 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


Source: Galderma

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