Friday, July 1, 2016
FDA approves Juvéderm Volbella XC
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.
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.