FDA OKs Restylane for lip augmentation
Scottsdale, Ariz. —The Food and Drug Administration has
approved the use of the facial filler Restylane (hyaluronic acid, Medicis) for
lip augmentation, GlobeNewswire reports.
Restylane was approved in 2003 to treat moderate-to-severe facial wrinkles.
The new label will now include an indication for submucosal implantation for lip
augmentation in patients age 21 and older. The package insert also will include
the new indication, along with clinical trial results.
A randomized, multicenter study enrolled 180 patients to evaluate Restylane’s
safety and effectiveness for lip augmentation in the upper and lower lip.
Patients randomized to Restylane treatment at the start of the study were
re-treated at six months, while patients randomized to no treatment received
their first Restylane treatment at six months. Safety was measured by adverse
events reported throughout the study and patient diaries kept for two weeks
According to the company, Restylane was well-tolerated and highly effective
for lip augmentation for up to six months. Adverse events — none considered
serious — included pain, swelling, tenderness, bruising and erythema.
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