Allergan
announced June 1 that the FDA had approved its Volbella XC filler for use in
the lips and perioral rhytids. The filler was found in a study to increase lip
fullness and soften perioral lines through one year.
Juvéderm
Volbella XC will be available to U.S. patients in October 2016, according to
Allergan.
The FDA
describes Volbella XC as “a sterile, biodegradable, non-pyrogenic,
viscoelastic, clear, colorless, homogeneous gel implant. It consists of
cross-linked hyaluronic acid (HA) produced by Streptococcus species of
bacteria, formulated to a concentration of 15 mg/mL and 0.3% w/w lidocaine in a
physiologic buffer.”
The Clinical Trial
Researchers
conducted a prospective, double-blind, randomized, controlled, multicenter
clinical study evaluating Volbella’s safety and effectiveness compared to a
control for injection into the lips and perioral area. In the study, 168
subjects received Volbella XC and 56 were in the control group. If considered
necessary for optimal correction, researchers could do a touch-up treatment
about one month after the first treatment.
Researchers
then followed subjects at 1, 3, 6, 9 and 12 months after the last treatment.
The
primary endpoint was the analysis of non-inferiority of Volbella XC relative to
control in terms of change from baseline to month 3 in mean lip fullness based
on Evaluating Investigator assessments using the validated 5-point Allergan Lip
Fullness Scale (LFS), according to the FDA.
The
average volume of Volbella XC injected to achieve optimal results was 2.6 mL.
Researchers injected a median volume of 1.0 mL in the upper lip, 0.8 mL in the
lower lip, 0.3 mL in perioral lines, 0.5 mL in oral commissures and 0.1 mL in
philtral columns.
Injections
into the upper and lower vermilion tended to be subdermal, while injections
into the vermilion border, Cupid’s bow, philtral columns, perioral lines and
oral commissures were generally intradermal. Injectors used these or a
combination of techniques to achieve optimal results: tunneling technique,
serial puncture technique and fanning technique.
They
found the mean change from baseline to month 3 on the Allergan Lip Fullness
Scale (LFS) was 1.1 for subjects treated with Volbella XC versus 1.0 for
subjects in the control arm.
VYCROSS Technology
Bill
Meury, Allergan’s chief commercial officer, says in a press release about the
approval that Volbella XC is the first such product in the U.S. to be
formulated with VYCROSS, a proprietary filler technology, engineered to address
specific patient concerns such as lip fullness, age-related volume loss in the
cheek area or perioral rhytids. VYCROSS blends different molecular weights of
hyaluronic acid which contributes to the gel's duration.
Charlotte,
N.C., based facial plastic surgeon Jonathan Kulbersh, M.D., says in a press
release responding to the approval that the VYCROSS technology is said to
result in less pain from injection, less swelling and a more natural looking
result.
“From
what I understand, Volbella was developed to become the first-choice filler to
be used for the lips. I’ve heard nothing but good things about the product. The
majority of patients, even when you warn them that there will most likely be
swelling after having lip injections, are surprised by how inflated their lips
become, so the minimal swelling attribute alone will likely make Volbella the
most popular lip filler once it is released,” says Dr. Kulbersh in the release.
The news
isn’t all positive, however. Researchers reported January 2016 in Dermatologic
Surgery on a higher-than-expected rate of late cutaneous reactions post
Volbella injection into the tear trough area or lips. Broad-spectrum
antibiotics along with repeated high-dose hyaluronidase injections into the
inflammatory nodules effectively treated the cutaneous reactions, they write.
Dr.
Kulbersh reports no relevant disclosures.
Lisette
Hilton
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