Juvederm study/trial for wrinkle reduction in patients.

1. JUVÉDERM®
Family of Hyaluronic Acid Fillers

2. 2
JUVÉDERM® XC Sets the Standard
The first and only smooth-consistency gel
formulated with lidocaine
Provides a more comfortable
patient experience1-3,*
The only HA filler FDA approved† to last up to
1 year with initial treatment1,2,‡
FDA = US Food and Drug Administration; HA = hyaluronic acid.
*When compared to the nonlidocaine JUVÉDERM® formulations.
†
In the United States, JUVÉDERM® injectable gel is indicated for injection into the mid-to-deep dermis for correction of moderate to severe facial
wrinkles and folds (such as nasolabial folds).
‡
This includes all JUVÉDERM® injectable gel formulations.
1. JUVÉDERM® Ultra XC Directions for Use; 2. JUVÉDERM® Ultra Plus Directions for Use; 3. Weinkle et al. J Cosmet Dermatol. 2009.

3. 3
JUVÉDERM XC Possesses Unique Physical
®
and Chemical Properties¹
• HYLACROSS™ technology: robust and smooth consistency1
– Proprietary cross-linking and homogenization
– Uniform extrusion force and smooth flow
– Random sizes and shapes that result in a smooth-consistency gel
– Results in a unique 3D matrix that is strong and robust, yet
still soft and smooth
JUVÉDERM® Competitive HA fillers
More cross-linked Smooth consistency Less cross-linked Granular consistency
The significance of the difference has not been established in controlled clinical studies.
1. Data on file, Allergan, Inc.; JUVÉDERM® Technical File.

4. 4
Adding Lidocaine as a Dry Substance Ensures the Same
Chemical and Physical Characteristics as
JUVÉDERM® Injectable Gel Without Lidocaine
• Addition of lidocaine has no effect on1,2:
– HA concentration or volume – Product viscosity or extrusion force
– HA degradation – pH level
1. Weinkle et al. J Cosmet Dermatol. 2009; 2. Data on file, Allergan, Inc.

5. 5
Functional Equivalence Between JUVÉDERM ®
and JUVÉDERM® XC
• Lidocaine, when added as dry substance, does not increase the
volume of the gel, dilute the HA content, or interfere with HA
cross-linking1,2
• Lidocaine is rapidly released from the gel and metabolized after the
dermal filler is injected1,2
JUVÉDERM® Injectable Gel
Chemical/Physical Test
With and Without Lidocaine
Susceptibility to degradation
• Enzymatic Equivalent
• Free radical
Rheologic properties Equivalent
pH Equivalent
Extrusion force Equivalent
1. Weinkle et al. J Cosmet Dermatol. 2009; 2. Data on file, Allergan, Inc.

6. 6
Summary of JUVÉDERM Physical ®
and Chemical Properties¹
JUVÉDERM ®
JUVÉDERM ® JUVÉDERM ® JUVÉDERM ®
Ultra
Ultra Ultra XC Ultra Plus
Plus XC
Lidocaine concentration NA 0.3% NA 0.3%
Total HA concentration 24 mg/mL 24 mg/mL 24 mg/mL 24 mg/mL
Percentage
~10% ~10% ~10% ~10%
uncross-linked HAa
Degree of cross-linking ~6% ~6% ~8% ~8%
Smooth Smooth Smooth Smooth
Formulation
cohesive gel cohesive gel cohesive gel cohesive gel
Needle 30 G 30 G 27 G 27 G
a
Uncrosslinked HA is defined as the portion of the product including lightly cross-linked chains and fragments that will aid extrusion/flow.
1. Data on file. Allergan, Inc; JUVÉDERM® Technical File.

7. 7
JUVÉDERM XC Pivotal Study: ®
Comparison of Effectiveness and Safety
With JUVÉDERM®¹
Multicenter, double-blind, randomized, within subject comparison
• 72 subjects total (18 subjects at each center)
• 4 study centers
Randomization
• JUVÉDERM® XC in 1 NLF
• JUVÉDERM® (without lidocaine) in the opposite NLF
Protocol
• Use of dental block was not permitted in the study
• Investigators determined appropriate formulation (JUVÉDERM® Ultra or
JUVÉDERM® Ultra Plus) and filler volume up to a maximum total volume
of 2 syringes (1.6 mL) per NLF
NLF = nasolabial fold.
1. Weinkle et al. J Cosmet Dermatol. 2009.

8. 8
JUVÉDERM XC Study Flow ®
and Assessments¹
Day 2 Day 14
Day 0 (Phone/e-mail) (Office visit)
JUVÉDERM®
treatment
Investigator Baseline Investigator Assessment: Investigator Day 14
Assessment: Common treatment-site Assessment:
NLF Severity Scale (NLFSS) responses (CTRs) NLF Severity Scale (NLFSS)
Treatment:
Investigator Assessment:
Randomization,
CTRs
injection volume, technique
Subject Assessment: Subject Assessment:
Procedural pain score NLF Severity Scale (NLFSS)
Comparative procedural pain score
NLF Severity Scale (NLFSS)
Subject Diary for CTRs
1. Weinkle et al. J Cosmet Dermatol. 2009.

9. 9
JUVÉDERM XC Subject and Investigator
®
Effectiveness Assessments¹
Primary: Procedural Pain
Subjects rated pain during injection;
0–10 scale within 30 minutes after both sides were treated
0 10
1 2 3 4 5 6 7 8 9 Worst
No pain pain imaginable
Secondary: Comparative Procedural Pain Scale (CPPS)
Subjects compared procedural pain between the right and left NLF;
5-point scale immediately and within 30 minutes after both sides were treated
-2 -1 0 1 2
Right slightly more Left slightly more
Right more painful painful No difference painful Left more painful
Secondary: NLF Severity Scale (NLFSS)
Investigators and subjects rated NLF severity;
5-point scale at pretreatment and day 14
0 1 2 3 4
None Mild Moderate Severe Extreme
1.Weinkle et al. J Cosmet Dermatol. 2009.

10. 10
JUVÉDERM XC Subject and Investigator
®
Safety Assessments¹
• Subjects maintained diary records using a validated
interactive voice response system (IVRS) for 2 weeks to
track CTRs
• Subjects reported absence or presence, severity, and
location (right or left NLF) of the most common CTRs
• Subjects also reported and investigators solicited
additional CTRs
CTR = common treatment-site response
1.Weinkle et al. J Cosmet Dermatol. 2009; 2. Data on file, Allergan, Inc.

11. 11
JUVÉDERM XC Provides a More ®
Comfortable Patient Experience 1-3
More Than 90% of the Subjects JUVÉDERM® XC Provides Significant
Reported Less Treatment Pain Reduction in Pain Compared With
With JUVÉDERM® XC1-3,* JUVÉDERM® Without Lidocaine1-3,*
(N = 72)
Less painful
63%
64% reduction
29%
Slightly
less painful
4%
With Lidocaine Without Lidocaine
More painful 3%
Slightly more painful P < .001 (N=72)
*When compared to the nonlidocaine JUVÉDERM® formulations.
†
For the primary measure, the absolute mean difference in pain score (3.4) exceeds the minimum clinically significant difference of 1.4 established a priori,
which demonstrates a clinically meaningful difference in pain for JUVÉDERM® with lidocaine
1. JUVÉDERM® Ultra XC Directions for Use; 2. JUVÉDERM® Ultra Plus Directions for Use; 3. Weinkle et al. J Cosmet Dermatol. 2009.

12. 12
With the Exception of Pain and Tenderness,
CTRs Were Similar for All JUVÉDERM®
Formulations 1-3
• Most CTRs were mild to moderate in severity and were
consistent with those typical of HA fillers
– Pain and tenderness were significantly reduced for
JUVÉDERM® XC
– No subject reported severe pain for JUVÉDERM® XC
• There were no adverse events other than CTRs related to
treatment
• The potential for allergic reactions to lidocaine is reduced
due to the use of preservative-free powder4
1.JUVÉDERM® Ultra XC Directions for Use; 2. JUVÉDERM® Ultra Plus Directions for Use; 3. Weinkle et al. J Cosmet Dermatol. 2009;
4. Jackson et al. J Am Dent Assoc. 1994 .

13. 13
Summary of JUVÉDERM XC ®
Registration Trial
Effectiveness
• 9 out of 10 patients reported less pain with JUVÉDERM® XC1,*
• Patient assessment of procedural pain with JUVÉDERM® XC averaged 2.0
(compared with an average of 5.4 without lidocaine) on an 11-point scale (0 = no pain
and 10 = worst pain imaginable)1
• NLF severity was significantly improved with both JUVÉDERM® XC and nonlidocaine
JUVÉDERM®
Safety
• With the exception of less pain and tenderness with JUVÉDERM® XC, CTRs were
similar for all JUVÉDERM® formulations1
• There were no adverse events other than CTRs related to treatment1
*When compared to the nonlidocaine formulations.
1. Weinkle SM et al. J Cosmet Dermatol. 2009.

14. 14
Pivotal Study: Design 1,2
• Multicenter, double-blind, randomized,
within-subject study
• Assess the effectiveness and safety of JUVÉDERM®*
compared with ZYPLAST® in the correction of moderate
to severe NLFs
– JUVÉDERM® Ultra (24 HV), n = 146
– JUVÉDERM® Ultra Plus (30 HV), n = 146
• Each site had
– Treating investigator (not masked)
– Independent expert reviewer (IER) (masked)
• All subjects masked
*Although 3 formulations of JUVÉDERM® were evaluated in the pivotal study, only 2 are currently available in the United States.
1. Pinksy et al. Aesthetic Surg J. 2008; 2. Data on file, Allergan, Inc.

15. 15
Pivotal Study: Treatment
and Assessment 1,2
• Treatment
– Subjects randomly assigned to receive either JUVÉDERM® Ultra or
JUVÉDERM® Ultra Plus in 1 NLF
– All subjects received ZYPLAST® in opposite NLF
– Injections were provided to achieve optimal correction
(1 or 2 touch-ups allowed within the first 4 weeks if necessary)
– Subjects followed for up to 24 weeks after last treatment
– At the conclusion of the randomized trial, an open-label, extended
follow-up study included observations out to ~ 1.5 years after last treatment
• Assessment
– Effectiveness: NLF severity rated by IER and subject on the
5-point NLF Severity Scale (NLFSS) (ie, none, mild, moderate, severe,
or extreme)
– Safety/tolerability: Subjects recorded treatment-site reactions daily for
14 days after initial treatment and each touch-up
IER = Independent expert reviewer
1. Pinksy et al. Aesthetic Surg J. 2008; 2. Data on file, Allergan, Inc.

16. 16
JUVÉDERM Open-Label Extended ®
Follow-up Study: Methods
• After completing 24 weeks of follow-up during the pivotal trial, subjects could
return at their convenience for a complimentary repeat treatment with their
preferred product1
• Subjects were assessed by the treating investigator when they returned for
re-treatment (up to approximately 1.5 years after last treatment)2
• The number of subjects evaluated during the extended trial were1:
– 116 of the 146 (79%) subjects in the JUVÉDERM® Ultra
injectable gel cohort
– 111 of the 146 (76%) subjects in the JUVÉDERM® Ultra Plus
injectable gel cohort
• Subjects returning for the follow-up study were representative of the pivotal
trial subjects in terms of1:
– Baseline nasolabial fold (NLF) severity
– NLF severity at week 24
– Initial injection volume
1. Pinksy et al. Aesthetic Surg J. 2008; 2. Data on file, Allergan, Inc., Pinsky Final Report.

17. 17
Majority of JUVÉDERM Subjects Maintained a ®
Clinically Significant* Improvement
Longer Than 9 Months¹
JUVÉDERM® Ultra JUVÉDERM® Ultra Plus
Improvement in WAS, %
Subjects With ≥ 1-Point
*Improvement of ≥ 1 in wrinkle assessment score (WAS) as assessed by treating investigator is defined as clinically significant.
1. Pinksy et al. Aesthetic Surg J. 2008.

18. 18
JUVÉDERM Ultra Plus in Severe NLFs: ®
Physician Assessment¹
• Improvement of ≥ 1 point
achieved by
Subjects With Clinically Significant
– 96% of subjects at 24 weeks
– 81% of subjects at
Improvement, %
12 months or beyond
• Improvement of ≥ 2 points
achieved by
– 67% of subjects at 24 weeks
– 38% of subjects at
12 months or beyond
1. Adapted from Lupo et al. Plast Reconstr Surg. 2008.

19. 19
NLF Correction Over 17 Months:
JUVÉDERM® Ultra Plus¹
Baseline 2 weeks 8 weeks 24 weeks 17 months
1. Baumann et al. Dermatol Surg. 2007.

20. 20
JUVÉDERM Is the Only HA Filler FDA ®
Approved to Last up to 1 Year*
With Initial Treatment¹ ,2,†
• JUVÉDERM® Ultra and JUVÉDERM® Ultra Plus offer long-lasting clinical
improvement for up to 1 year in NLFs
– Majority of subjects maintained a clinically significant improvement
(≥ 1 point) over an extended period of time1,2
• JUVÉDERM® Ultra: 75% (> 9 months)
• JUVÉDERM® Ultra Plus: 78% (> 12 months)
• JUVÉDERM® Ultra Plus for severe NLFs: 81% (≥ 12 months)
• Repeat treatment required less than half of the original injection volume
• No treatment-related adverse events other than at the injection site
*In the United States, JUVÉDERM® injectable gel is indicated for injection into the mid-to-deep dermis for correction of moderate to severe facial wrinkles
and folds (such as nasolabial folds).
†
This includes all JUVEDERM injectable gel formulations.
1. Pinksy et al. Aesthetic Surg J. 2008; 2. Lupo et al. Plast Reconstr Surg. 2008.

21. 21
HA Resistance to Ovine Testicular
Hyaluronidase (OTH) Methods¹
• Study purpose
– To determine a dose-response relationship between
commercially available OTH and degradation of various
HA-based dermal filler products
• Dose response
– Test products incubated for 30 minutes with OTH concentrations
of 0, 5, 10, 20, and 40 U
• Time response (fixed 20-U enzyme concentration)
– JUVÉDERM®: 30, 60, 120 minutes; 24 hours
• Outcome measure
– Amount of soluble HA and molecular weight as determined by
SEC-MALS detector
– An increase in total soluble HA indicates degradation of the
HA network
SEC-MALS = size-exclusion chromatography coupled with a multiangle light scattering; soluble HA = uncross-linked HA or lightly cross-linked
HA chains or fragments that are in soluble form.
1. Jones et al. Dermatol Surg. In press.

22. 22
JUVÉDERM® Has Greater Resistance to Degradation Than
Restylane®, Yet Is Still Mostly
,*,†
Dissolved by OTH Within 24 Hours¹
Units of Ovine Testicular Hyaluronidase (OTH)
After 30-Minute Incubation
% Free HA
JUVÉDERM® Restylane®
Free HA = uncross-linked HA and lightly cross-linked chains or fragments that are in soluble form.
*In vitro.
†
Based on JUVÉDERM® Ultra Plus.
1. Jones et al. Dermatol Surg. In press.

23. 23
Practical Uses for JUVÉDERM® XC
JUVÉDERM® JUVÉDERM®
Ultra XC Ultra Plus XC
*In the United States, JUVÉDERM® injectable gel is indicated for injection into the mid-to-deep dermis for correction of moderate to
n
severe facial wrinkles and folds (such as nasolabial folds).

24. 24
JUVÉDERM® Product Availability
Product description Syringe size
JUVÉDERM® Ultra XC 0.8 cc
JUVÉDERM® Ultra Plus XC 0.8 cc
JUVÉDERM® Ultra 0.8 cc
JUVÉDERM® Ultra Plus 0.8 cc
JUVÉDERM® Ultra Plus 0.4 cc
JUVÉDERM® Ultra 0.4 cc

25. 25
JUVÉDERM® XC Sets the Standard
The first and only smooth-consistency gel
formulated with lidocaine
Provides a more comfortable
patient experience1-3,*
The only HA filler FDA approved† to last up to
1 year with initial treatment1,2,‡
FDA = US Food and Drug Administration; HA = hyaluronic acid.
*When compared to the nonlidocaine JUVÉDERM® formulations.
†
In the United States, JUVÉDERM® injectable gel is indicated for injection into the mid-to-deep dermis for correction of moderate to severe facial
wrinkles and folds (such as nasolabial folds).
‡
This includes all JUVÉDERM® injectable gel formulations.
1. JUVÉDERM® Ultra XC Directions for Use; 2. JUVÉDERM® Ultra Plus Directions for Use; 3. Weinkle et al. J Cosmet Dermatol. 2009.

26. 26
A Brief Description of Indications for Use,
Contraindications, Warnings, Precautions, and Adverse
Events for JUVÉDERM® Injectable Gel
Indication: In the United States, JUVÉDERM® injectable gel (including
JUVÉDERM® Ultra, JUVÉDERM® Ultra Plus, JUVÉDERM® Ultra XC, and
JUVÉDERM® Ultra Plus XC) is indicated for injection into the mid-to-deep
dermis for correction of moderate to severe facial wrinkles and folds (such as
nasolabial folds).
Contraindications: JUVÉDERM® injectable gel should not be used in patients
who have severe allergies marked by a history of anaphylaxis or history or
presence of multiple severe allergies. JUVÉDERM® should not be used in
patients with a history of allergies to Gram-positive bacterial proteins.
JUVÉDERM® Ultra XC and JUVÉDERM® Ultra XC should not be used in
patients with a history of allergies to lidocaine.
Warnings: JUVÉDERM® injectable gel should not be injected into blood
vessels. If there is an active inflammatory process or infection at specific
injection sites, treatment should be deferred until the underlying process
is controlled.

27. 27
A Brief Description of Indications for Use,
Contraindications, Warnings, Precautions, and Adverse Events
for JUVÉDERM® Injectable Gel (continued)
Precautions: The safety of JUVÉDERM® for use during pregnancy, in
breastfeeding females, or in patients under 18 years has not been established.
The safety and effectiveness of JUVÉDERM® injectable gel for the treatment of
areas other than facial wrinkles and folds (such as lips) have not been
established in controlled clinical studies. Patients who are using substances that
can prolong bleeding, such as aspirin or ibuprofen, as with any injection, may
experience increased bruising or bleeding at injection site. Patients should inform
their physician before treatment if they are using these types of substances. As
with all skin-injection procedures, there is a risk of infection. JUVÉDERM® should
be used with caution in patients on immunosuppressive therapy, or therapy used
to decrease the body’s immune response, as there may be an increased risk of
infection. The safety of JUVÉDERM® in patients with a history of excessive
scarring (eg, hypertrophic scarring and keloid formations) and pigmentation
disorders has not been studied. If laser treatment, chemical peel, or any other
procedure based on active dermal response is considered after treatment with
JUVÉDERM® injectable gel, or if JUVÉDERM® is administered before the skin has
healed completely after such a procedure, there is a possible risk of an
inflammatory reaction at the treatment site.

28. 28
A Brief Description of Indications for Use,
Contraindications, Warnings, Precautions, and Adverse
Events for JUVÉDERM® Injectable Gel (continued)
Adverse events: The most commonly reported side effects are temporary
injection-site redness, swelling, pain/tenderness, firmness, lumps/bumps, and
bruising. Most side effects are mild or moderate in nature, and their duration is
short lasting (7 days).
Important: For full safety information, please visit www.juvederm.com or call
Allergan Product Support at 1-877-345-5372.
CAUTION: Rx only.
For directions for use (DFU), please visit www.juvederm.com/dfu.

29. 29
Bibliography
Baumann LS, Shamban AT, Lupo MP, et al; JUVÉDERM® vs. ZYPLAST® Nasolabial Fold Study Group. Comparison of smooth-gel
hyaluronic acid dermal fillers with cross-linked bovine collagen: a multicenter, double-masked, randomized, within-subject study.
Dermatol Surg. 2007;33(suppl 2):128S-135S.
Data on file, Allergan, Inc.
Data on file, Allergan, Inc.; JUVÉDERM® Technical File.
Data on file, Allergan, Inc., Pinsky Final Report.
Jackson D, Chen AH, Bennett CR. Identifying true lidocaine allergy. J Am Dent Assoc. 1994;125(10):1362-1366.
Jones B, Borrell M, Tezel A. Degradation by ovine testicular hyaluronidase (OTH): a comparison between a 24-mg/mL hyaluronic acid
(HA) gel filler and 20- and 5.5-mg/mL HA gel fillers. Dermatol Surg. In press.
JUVÉDERM® Ultra XC Directions for Use.
JUVÉDERM® Ultra Plus XC Directions for Use.
Lupo MP, Smith SR, Thomas JA, Murphy DK, Beddingfield FC 3rd. Effectiveness of JUVÉDERM® Ultra Plus dermal filler in the treatment
of severe nasolabial folds. Plast Reconstr Surg. 2008;121(1):289-297.
Pinsky MA, Thomas JA, Murphy DK, Walker PS; for JUVÉDERM® vs ZYPLAST® Nasolabial Fold Study Group. JUVÉDERM® injectable
gel: A multicenter, double-blind, randomized study of safety and effectiveness. Aesthetic Surg J. 2008;28(1):17-23.
Weinkle SH, Bank DE, Boyd CM, Gold MH, Thomas JA, Murphy DK. A multi-center, double-blind, randomized controlled study of the
safety and effectiveness of JUVÉDERM® injectable gel with and without lidocaine. J Cosmet Dermatol. 2009;8(3):205-210.
©2010 Allergan, Inc. ® and ™ marks owned by Allergan, Inc.
JUVÉDERM® mark owned by Allergan Industrie, SAS.
EMLA is a registered trademark of Deutsche Bank AG, London Branch. Restylane is a registered trademark
of HA North American Sales AB.
www.juvederm.com/professional
APC25QE10 104622