Following FDA Approval, Restylane Kysse is Now Widely Available for Lip Augmentation and Wrinkles Above the Upper Lips

Fort Worth, TX – (July 6, 2020) – Galderma today announced results of a first-of-its-kind phase IV, Kissability study for an injectable hyaluronic acid (HA) lip filler, evaluating not only subject satisfaction but, for the first time, partner satisfaction following treatment with Restylane^® Kysse. Many consumers report they often keep their lip treatments a secret and have concerns about partner perceptions after injection. In the Kissability study, all subjects (100%) and a majority of their partners (90%) were satisfied with their lips after Restylane Kysse treatment, with most partners (73%) reporting a more kissable and natural feel.^1*

“The creative and unique approach to this phase IV study design has allowed Galderma to distinctively showcase and amplify the data from both the patient and the partner perspectives,” said Alisa Lask, General Manager and Vice President of the U.S. Aesthetics Business at Galderma. "The proven global safety profile, combined with the data, support Galderma's plan to establish Restylane Kysse as a leader in the U.S. lip filler market."

The phase IV Kissability data also found that subjects agreed that their lips had a natural look (96%) and that they felt more attractive (87%) after treatment with Restylane Kysse.^1* 98% of subjects also reported they were satisfied with the kissability of their lips after treatment.^1*

"The phase IV Kissability study helps answer the ongoing question from patients to their aesthetic provider: 'How will my partner react?' The data from this study supports that Restylane Kysse resulted in overwhelmingly positive partner satisfaction with both kissability and appearance," said Dr. Janelle Vega, board-certified dermatologist and paid Galderma consultant in Miami, FL. "The use of XpresHAn Technology™ in Restylane Kysse helps patients look more natural when they are smiling, speaking, laughing, and even kissing - right in time for International Kissing Day!”^1,2,3

All subjects in the Restylane Kysse phase IV study were over the age of 21, in a steady relationship with a partner for at least 6-months and had the intent to undergo lip augmentation. Completed separately by the subject and their partners, at home, the innovative Kissability Questionnaire explored how satisfied partners were with subjects' lips after injection, and if they were even more kissable. Primary endpoint included subject-assessed Global Aesthetic Improvement Scale (GAIS) at week 8 and secondary endpoints included independent photographic review of naturalness of expression, age, and lip texture, adverse events (AEs), FACE-Q satisfaction with lips (subject) and Kissability questionnaire (between visits).¹ This phase IV study was open to people of all races and ethnicities. This has been a critical factor in the design of all of our aesthetic studies since 2016 so that our research is reflective of the world we all live in.

Following approval by the U.S. Food and Drug Administration (FDA) earlier this year, Restylane Kysse is the latest addition to the Restylane^® family of HA dermal fillers — the broadest portfolio of dermal fillers in the world.⁴ The first HA filler specifically indicated for the lips using XpresHAn Technology™, Restylane Kysse, is designed to enhance existing beauty through natural-looking volume and Kysse-able softness that lasts for up to 1 year.^1,2,5

With over 40 million treatments worldwide, the portfolio of products helps 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).^1,2,4

Galderma is working closely with their aesthetic healthcare provider partners, while following all safe and proper social distancing guidelines, to offer Restylane Kysse in healthcare providers’ respective practice locations across the country. For more information, ask your provider for a Restylane Kysse consultation and treatment options. To find a specialist, visit www.RestylaneUSA.com/specialist.

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.

Media Contacts
Shannon Iwaniuk
Corporate Communications, Galderma Laboratories, L.P. media@galderma.com

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.

* In a phase IV clinical study, 59 subjects were treated with Restylane Kysse in the lips (n=19) or Restylane Kysse in the lips in combination with either Restylane Refyne (n=21) or Restylane Defyne (n=37) in the NLFs or MLs.

1  Data on File, 05DF1807 Clinical Study Report. Fort Worth, TX: Galderma Laboratories, L.P., 2020.
2  Restylane Kysse. Instructions for Use. Galderma Laboratories, L.P., 2020
3 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.
4 Restylane. Restylane Heritage. https://www.restylane.com/en/heritage. Accessed May 29, 2020.
5 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