GALDERMA RECEIVES FDA APPROVAL FOR ITS NEWEST HYALURONIC ACID FILLER, RESTYLANE® EYELIGHT

Restylane Eyelight is the first and only product in the U.S. to use NASHA^® Technology to improve the appearance of undereye hollows for up to 18 months¹

DALLAS, June 5, 2023 /PRNewswire/ -- Galderma announced today the U.S. Food and Drug Administration (FDA) approved Restylane^® Eyelight for the treatment of undereye hollows, also known as dark shadows, in adults over the age of 21.¹ Restylane Eyelight, an undereye hyaluronic acid (HA) dermal filler, is the first and only product in the U.S. formulated with NASHA^® Technology for volume loss under the eyes, giving patients natural-looking results.¹

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"Restylane Eyelight is an exciting new treatment option for patients. Formulated with NASHA Technology, this filler is close to the body's natural hyaluronic acid with minimal crosslinking and produces a firm gel texture (or 'supportive gel') that is resistant to water absorption, which makes Restylane Eyelight a safe, natural-looking solution for volume loss under the eyes.^2-4"

BILL ANDRIOPOULOS, PH.D.
VICE PRESIDENT, MEDICAL AFFAIRS
GALDERMA U.S.

For millions of Americans, dark circles can make individuals feel older, tired and stressed.⁵ Dr. Carolyn Jacob, a board-certified dermatologist based in Chicago and a lead investigator in the clinical trial of Restylane Eyelight sees firsthand how undereye concerns are top of mind for consumers.

"Many of my patients seek treatment for hollows under the eyes, and topical products such as creams, concealers and undereye masks just aren't able to solve the problem and provide the long-lasting results they are seeking. I'm pleased to see that Restylane Eyelight offers a safe, effective and natural-looking outcome that enables my patients to achieve their aesthetic undereye goals, with results that last up to 18 months with optimal treatment.^1,6"

CAROLYN JACOB
BOARD CERTIFIED DERMATOLOGIST & MEDICAL DIRECTOR
CHICAGO COSMETIC SURGERY AND DERMATOLOGY
PAID GALDERMA CONSULTANT

This FDA approval is supported by efficacy and safety data from a randomized, evaluator-blinded, parallel group, no-treatment controlled, multi-center Phase 3 study to evaluate the effectiveness and safety of Restylane Eyelight for correction of volume loss under the eyes.⁶

Lack of volume and volume loss in the undereye region can create shadows and emphasize dark circles, leading to the appearance of tiredness and/or aging.⁷ In the Phase 3 study, 87% of patients* had reduced undereye hollowness at 3 months,^6† and Restylane Eyelight was found to be well tolerated under the eyes. At 3 months, 92% of patients* were pleased with their results, and 84% were still pleased through 1 year.⁶ The study also yielded high satisfaction, with 93% of patients* expressing interest in receiving treatment again after 12 months.⁶

Restylane's legacy with safety continues with this Phase 3 trial where most patients* (87%) did not experience adverse events related to treatment with Restylane Eyelight,⁶ giving patients a new treatment option that is safe and effective for the under eyes.

The most commonly observed side effects for undereye injection are swelling, redness, tenderness, pain, bruising, itching, and lumps or bumps at the injection site.^1,6 Most adverse events were mild in severity (75%) and none were severe. There was no incidence of Tyndall effect (blue discoloration) after treatment with Restylane Eyelight.

^{*Patient=Clinical trial subject
† At least 1-grade improvement on the Galderma Infraorbital hollows scale (GIHS)}

Availability of Restylane Eyelight

Restylane Eyelight will be available in aesthetic practice locations across the country over the next several months. To learn more about Restylane Eyelight and the full Restylane portfolio visit RestylaneUSA.com and follow @RestylaneUSA.

About Galderma's Restylane Product Portfolio

The FDA approval of Restylane Eyelight adds to Galderma's growing Restylane product portfolio. With over 65 million treatments worldwide and counting, the Restylane family of HA dermal fillers is the broadest portfolio of dermal fillers in the U.S.^8‡ Please refer to the safety information for the approved uses of the Restylane product portfolio.

^{‡ Based on rheological properties (G' and X strain)} 

About Galderma

Galderma is the pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that spans the full spectrum of the fast-growing dermatology market through Injectable Aesthetics, Dermatological Skincare and Therapeutic Dermatology. Since our foundation in 1981, we have dedicated our focus and passion to the human body's largest organ – the skin – meeting individual consumer and patient needs with superior outcomes in partnership with healthcare professionals. Because we understand that the skin we're in shapes our lives, we are advancing dermatology for every skin story. 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.

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, Restylane® Contour, and Restylane® Eyelight.

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.

Restylane® Eyelight is for the improvement of infraorbital hollowing.

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. Delayed-onset inflammation near the site of dermal filler injections is one of the known adverse events associated with dermal fillers, and cases have been reported to occur at the dermal filler treatment site following viral or bacterial illnesses or infections, vaccinations, or dental procedures. Typically, the reported inflammation was responsive to treatment or resolved on its own.  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.

REFERENCES AND NOTES

1. Restylane Eyelight. Instructions for Use. Galderma Laboratories, L.P. 2023.
2. Data on file. MA-34483 Study Report. Galderma Laboratories, L.P. 2021.
3. Kablik J, Monheit GD, Yu L, et al. Comparative physical properties of hyaluronic acid dermal fillers. Dermatol Surg. 2009 Feb; 35 Suppl 1:302-12.
4. Data on file. MA-53297 Study Report. Galderma Laboratories, L.P. 2022.
5. Data on file. Analysis of consumer social media conversation/digital behaviors. Galderma Laboratories, L.P. 2023.
6. Data on file. 43USTT1904 Clinical Study Report. Galderma Laboratories, L.P. 2022.
7. Vrcek I, Ozgur O, Nakra T. Infraorbital Dark Circles: A Review of the Pathogenesis, Evaluation and Treatment. J Cutan Aesthet Surg. 2016 Apr-Jun;9(2):65-72.
8. Data on file. MA-39680 Report. Galderma Laboratories, L.P. 2023.

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SOURCE Galderma Aesthetics