FDA approves hyaluronic acid filler for lip augmentation, perioral rhytids

The Food and Drug Administration has approved Restylane Kysse, a hyaluronic acid filler, for lip augmentation and the correction of upper perioral rhytids in adults aged over 21 years, the manufacturer has announced.

Approval was supported by results of a phase 3 clinical trial in which a lower amount of Restylane Kysse was needed to see an improvement in lip fullness (1.82 mL) vs. a comparator (2.24 mL), according to the press release issued by Galderma. After 1 year, 78% of those who received the Restylane product were satisfied, and it was also shown to be safe and well tolerated, the release said.

In the statement, the company said that it is “working to determine the appropriate launch timing and availability” of this new product.

lfranki@mdedge.com

The Food and Drug Administration has approved Restylane Kysse, a hyaluronic acid filler, for lip augmentation and the correction of upper perioral rhytids in adults aged over 21 years, the manufacturer has announced.

Approval was supported by results of a phase 3 clinical trial in which a lower amount of Restylane Kysse was needed to see an improvement in lip fullness (1.82 mL) vs. a comparator (2.24 mL), according to the press release issued by Galderma. After 1 year, 78% of those who received the Restylane product were satisfied, and it was also shown to be safe and well tolerated, the release said.

In the statement, the company said that it is “working to determine the appropriate launch timing and availability” of this new product.

lfranki@mdedge.com

The Food and Drug Administration has approved Restylane Kysse, a hyaluronic acid filler, for lip augmentation and the correction of upper perioral rhytids in adults aged over 21 years, the manufacturer has announced.

Approval was supported by results of a phase 3 clinical trial in which a lower amount of Restylane Kysse was needed to see an improvement in lip fullness (1.82 mL) vs. a comparator (2.24 mL), according to the press release issued by Galderma. After 1 year, 78% of those who received the Restylane product were satisfied, and it was also shown to be safe and well tolerated, the release said.

In the statement, the company said that it is “working to determine the appropriate launch timing and availability” of this new product.

lfranki@mdedge.com