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Galderma Wins U.S. FDA Approval For Restylane Contour In Temple Hollowing

By RTTNews Staff Writer   ✉   | Published:   | Follow Us On Google News

Galderma Group Ltd (GDERF) said Monday that the U.S. Food and Drug Administration has approved Restylane Contour for the correction of temple hollowing in patients aged 21 and older, expanding its aesthetic portfolio.

The approval builds on the product's existing indications for cheek augmentation and midface contour deficiencies. It also follows the recent U.S. clearance of Restylane Lyft for chin augmentation, further broadening its use across areas including the midface, facial folds and wrinkles, the back of the hands, and the chin.

The decision was supported by clinical data showing that Restylane Contour significantly improved temple hollowing compared with no treatment at three months, with effects lasting up to 18 months.

In the study, 91% of patients were classified as treatment responders at three months, while more than 85% maintained a response through 18 months after initial treatment. Additionally, over 70% of patients reported looking younger, less tired, and more refreshed at 18 months, and 85% said their temples appeared natural at that time point.

All treatment-related adverse events were reported as mild to moderate, with no serious safety concerns observed.

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