Galderma (GDERF) has received expanded U.S. FDA approval for Restylane Contour for the correction of temple hollowing in adults over 21, broadening its existing indications for cheek augmentation and midface contour deficiencies.
Restylane Contour is a part of Galderma's hyaluronic-acid injectable portfolio and uses the company's OBT/ XpresHAn technology, designed to provide natural-looking facial volume that moves with expression.
The FDA decision was supported by an 18-month prospective, multicenter study using a dual-layer injection technique with both needle and cannula. Clinical data showed that 91% of patients responded at three months, with results lasting up to 18 months, and no serious treatment-related adverse events reported. Temple hollowing is a common age-related concern, affecting an estimated 40% of individuals by age 40, according to the company.
Restylane first received FDA approval in December 2003 for correction of moderate to severe facial wrinkles and folds, such as nasolabial folds. The product later gained approval for lip augmentation in patients over 21.
The new indication arrives as Galderma continues to expand its aesthetics franchise. In its latest financial report, the company reported $5.027 billion in 2025 net sales, up 17.7% from $4.410 billion, with Injectable Aesthetics contributing $2.572 billion, up 11.5% from $2.299 billion year-over-year. Restylane is a key contributor within this segment, which continued to outpace the broader aesthetics market.
Galderma noted that temple hollowing is an increasingly common aesthetic concern, particularly among individuals experiencing medication-driven weight loss. The company said the expanded approval supports its strategy to address emerging facial-volume needs across age groups.
Restylane Contour will be available through licensed aesthetic practitioners in the U.S.
GDERF has traded between $108.10 and $213.50 over the past year. The stock closed Friday's trading (March 20, 2026) at $188.30, up 4.99%.
(Amended: An earlier version of this article incorrectly stated, "The company noted that Restylane Contour is now the first and only hyaluronic-acid filler approved by the FDA for this specific area." This was not a claim made by the company. Restylane Contour is FDA-approved for the correction of temple hollowing, but it is not the first or only filler approved for this area).
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