Galderma Receives FDA Approval for New Hyaluronic Acid Filler

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

“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-centre 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 ageing.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 discolouration) after treatment with Restylane Eyelight.

^{*Patient=Clinical trial subject}

^{† At least 1-grade improvement on the Galderma Infraorbital hollows scale (GIHS)}

^{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.}