new filler approval: juvederm volbella
TRANSCRIPT
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New Filler Approval: Juvederm Volbella
Karol A Gutowski, MD, FACS
Hot Topics
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Disclosures
Angiotech/Surgical Specialties - Advisory Board
AxcelRx Pharmacuticals - Advisory Board
Suneva Medical - Instructor
Will use brand names due to lack of distinguishing generic names
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Status of Product
Juvederm Volbella XC
• Allergan
• Cross-linked hyaluronic acid injectable soft tissue filler
• Produced by Streptococcus
• 15 mg HA/mL + lidocaine
• (Ultra & Ultra Plus: 24 mg, Voluma: 20 mg)
Indications: Lips & perioral rhytides, >21 years old
FDA Status: Approved
Availability: October 2016
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Presentation Level of Evidence
Levels of Evidence and Qualifying Studies (Therapeutic Studies):I High-quality, multi-centered or single-centered, randomized controlled
trial with adequate power (N ≥ 100); or a systematic review of these studies
II Lesser-quality, randomized controlled trial; prospective cohort study; or systematic review of these studies
III Retrospective comparative study; case-control study; or a systematic review of these studies
IV Case series
V Expert opinion; case report or clinical example; or evidence based on physiology, bench research or "first principles“
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Treatment & Costs
• Product cost To be determined
• Disposables None (injection cannula $5-10)
• Treatment 1 to 6 syringes (2.6 average)
• Sessions 1 or 2
• Patient cost To be determined
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Recent FDA Approvals
• 2013 Voluma Cheek augmentation
• 2014 Restylane Silk Lips & perioral lines
• 2015 Restylane Lyft Facial folds
• 2015 Radiesse Hands
• 2015 Juvederm Lips & perioral lines
• 2016 Volbella Lips & perioral lines
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Match Filler to Need
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Physical Properties
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Hylacross vs Vycross Technology
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Juvederm Product Comparison
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G’ & Cohesivity
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Water Absorption
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Lift
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Moldability
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Pivotal Clinical Trial
Prospective multicenter, double blinded RCT
• Volbella XC n=168
• Restylane L = 56
• Optional touch up at 1 month (same in both groups)
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Primary Endpoint: Change in Lip Score
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Lip Lines
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Lip Satisfaction FACE Q
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Lip Fullness
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Perioral Lines Maximal Contraction
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Oral Commissure
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Global Aesthetic Improvement
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Lip Lines FACE Q
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Volbella Summary: Perioral & Lips
• Safe & effective
• 2 to 3 syringes for full effect
• Expect 6 to 9 month results
– Duration of effect depends on site
• Similar results as Restylane but lower G’?
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New Filler Approval: Juvederm Volbella
Karol A Gutowski, MD, FACS
Hot Topics