Galderma Announces FDA Approval of Restylane® Lyft For Midface Injection via Cannula
FORT WORTH, Texas,/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
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.
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.
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.
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:
Are there other precautions that I should discuss with my doctor?
Tell your doctor if you have diseases, injuries, or disabilities of the hand.
What are the possible side effects?
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.
© 2018 Galderma Laboratories, L.P.
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