Galderma Announces FDA Approval of Restylane® Lyft For Midface Injection via Cannula

FORT WORTH, Texas, Nov. 5, 2018 /PRNewswire/ -- Galderma Laboratories, L.P., a global leader focused on medical solutions in skin health, announced today that it has received U.S. Food and Drug Administration (FDA) approval for the use of Restylane Lyft^®, a hyaluronic acid (HA) dermal filler, with a small blunt tip cannula for cheek augmentation and the correction of age-related midface contour deficiencies in patients over the age of 21.¹ A small blunt tip cannula is a thin, flexible tube with a small opening on the side that provides an effective means for delivering fillers.²

"I am thrilled that the FDA has approved Restylane Lyft for midface via cannula. I prefer using a cannula vs. a needle when injecting specific areas of the face," said Dr. Anne Chapas, a board-certified dermatologist in New York City and clinical trial investigator for Restylane Lyft for midface injection via cannula. "In my experience, the use of a cannula may be associated with less potential damage to blood vessels, help minimize patient bruising, help decrease swelling, and allow for minimized downtime.³"

"The FDA approval of Restylane Lyft for midface via cannula marks the seventh FDA approval in aesthetics for Galderma in the past four years," said Alisa Lask, General Manager and Vice President of the U.S. Aesthetic Business at Galderma. "We have increased our investment in research and development this year in order to help grow the aesthetic market. Our goal is to continue to offer new solutions and delivery systems to our customers to help drive new patients in to aesthetic offices."

This approval is the second cannula indication for the Restylane family of dermal fillers. Restylane^® Silk for lip augmentation and Restylane Lyft for the midface are the only HA fillers on the market that are FDA-approved for use via cannula.^1,4

About the Cannula Study⁵

The multicenter, open-label, prospective study was conducted to assess the safety and efficacy of Restylane Lyft with Lidocaine for cheek augmentation and the correction of age-related midface contour deficiencies in conjunction with the use of a small blunt tip cannula in the midface. The 16-week study took place in four centers across the U.S., with 60 male and female subjects 22 years of age or older. At 16 weeks after treatment, 98.3% of subjects showed improvement in both the right and left midface based on the treating investigator's assessment using the Global Aesthetic Improvement Scale (GAIS), a global 7-point scale for aesthetic improvement in appearance.⁵

Following treatment, no severe related adverse events were observed. The majority of reported subject diary symptoms after initial treatment were tolerable (88.3%) and resolved within 7 days.⁵

Restylane Lyft is a safe, effective, and dissolvable dermal filler, and it is the only HA filler with three FDA-approved indications ? the midface/cheek, nasolabial folds, and back of the hands.^1,6 Restylane Lyft is proven to last in the midface area for up to 12 months.¹

About Restylane^®

With over 30 million treatments worldwide and counting⁷, the Restylane^® family of HA dermal fillers is the broadest portfolio of dermal fillers in the U.S. 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 and Restylane^®-L), and add lift and volume to the cheeks and the back of the hands (Restylane^® Lyft with Lidocaine).

To learn more about the Restylane^® family of products, visit www.RestylaneUSA.com.

About Galderma
Galderma, Nestlé Skin Health's medical solutions business, was created in 1981 and is now present in over 100 countries with an extensive product portfolio to treat a range of dermatological conditions. 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, hair and nails.

Strategic brands in the U.S. include Epiduo^® Forte Gel, Oracea^® Capsules, Mirvaso^® Gel, Soolantra^® Cream, Cetaphil^®, Differin^® Gel OTC, Restylane^®, Restylane^® Silk, Restylane^® Lyft with Lidocaine, Restylane^® Refyne, Restylane^® Defyne, Dysport^® and Sculptra^® Aesthetic.

For more information, please visit www.galdermausa.com and www.galderma.com.

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

Important Safety Information

The Restylane family of products includes Restylane®, Restylane-L®, Restylane® Lyft with Lidocaine, Restylane® Silk, Restylane® Refyne, and Restylane® Defyne.

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 in patients over the age of 21.

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 in patients over the age of 21. Restylane® Lyft with Lidocaine is also indicated for injection into the subcutaneous plane in the dorsal hand to correct volume deficit in patients over the age of 21.

Restylane® Silk is for lip augmentation and for correction of perioral wrinkles in patients over the age of 21.

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, in patients over the age of 21.

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, in patients over the age of 21.

Are there any reasons why I should not use products within the Restylane® family? (Contraindications)

To ensure a safe procedure, your doctor will talk to you about your medical history to determine if you are an appropriate candidate for treatment. You should not use products within the Restylane family if:

• You have severe allergies with a history of severe reactions (anaphylaxis)
• You are allergic to lidocaine or to any of the gram-positive bacterial proteins used to make hyaluronic acid
• You are prone to bleeding or have been diagnosed with a bleeding disorder

Are there other precautions that I should discuss with my doctor?

• Tell your doctor if you are breastfeeding, pregnant, or trying to become pregnant. The safety of these products for use during pregnancy, or in women who are breastfeeding, has not been studied
• Restylane, Restylane-L, Restylane® Lyft with Lidocaine, Restylane Refyne and Restylane Defyne are intended to treat facial wrinkles and folds, such as nasolabial folds. Restylane and Restylane-L are also intended for lip enhancement. Restylane® Lyft with Lidocaine is also intended for injection in the dorsal hand to correct volume loss. Treatments in other areas of the face or body have not been evaluated in clinical studies.
• The safety and effectiveness of Restylane® Silk for areas other than the lips and perioral area have not been evaluated in clinical studies.
• Tell your doctor if you have any history of scarring, particularly thick and stiff scars, or any pigmentation (skin color) disorders. These side effects can occur with hyaluronic acid fillers in general.
• Tell your doctor if you are planning other laser treatments or a chemical peel, as there is a possible risk of inflammation at the treatment site if these procedures are performed after treatment
• Patients who experience skin injury near the site of injection with these products may be at a higher risk for side effects
• Tell your doctor if you are on any medications to decrease your body's immune response (immunosuppressive therapy). Using these medications may increase your risk of bruising or bleeding at the gel injection site.
• Tell your doctor if you are using any "blood thinners" such as aspirin, warfarin, or any other medications that affect bleeding. Using these medications may increase your risk of bruising or bleeding at the gel injection site.
• The use of these products on gel injection sites with skin sores, pimples, rashes, hives, cysts, or infections should be postponed until healing is complete. Use of product in these areas could delay healing or make your skin problems worse.

Tell your doctor if you have diseases, injuries, or disabilities of the hand.

What are the possible side effects?
The most commonly observed side effects are swelling, redness, pain, bruising, headache, tenderness, lump formation, itching at the injection site, and impaired hand function. These are typically mild in severity and typically resolve in less than 7 days in nasolabial folds and less than 14 days in lips. Serious but rare side effects include delayed onset infections, recurrence of herpetic eruptions, and superficial necrosis at the injection site.

One of the risks with using this product is unintentional injection into a blood vessel. The chances of this happening are very small, but if it does happen, the complications can be serious, and may be permanent. These complications, which have been reported for facial injections, can include 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 of the Restylane products, please call Galderma Laboratories, L.P at 1-855-425-8722.

¹ Restylane^® Lyft Instructions for Use. Fort Worth, TX: Galderma Laboratories, L.P., 2018.
² Zeichner, JA & Cohen, JL. Use of Blunt Tipped Cannulas for Soft Tissue Fillers. J Drugs Dermatol. 2012;11(1):70-72. http://jddonline.com/articles/dermatology/S1545961612P0070X/1
³ DOI: 10.1016/j.fsc.2012.02.007
⁴ Restylane^® Silk Instructions for Use. Fort Worth, TX: Galderma Laboratories, L.P., 2017.
⁵ Data on file. 43USC1633 (MA-36147) Clinical Study Report. Fort Worth, TX: Galderma Laboratories, L.P., 2018.
⁶ Data on file. Fort Worth, TX: Galderma Laboratories, L.P., 2018.
⁷ Data on file. MA-31037 Report. Fort Worth, TX: Galderma Laboratories, L.P., 2016.

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SOURCE Galderma