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Page 1: Pirch_Latisse Core Deck Final

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LATISSE® (bimatoprost ophthalmic solution) 0.03% is the first and only FDA-approved product indicated to treat hypotrichosis of the eyelashes by increasing their growth, including length, fullness, and darkness.

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Page 3: Pirch_Latisse Core Deck Final

LATISSE® (bimatoprost ophthalmic solution) 0.03% is the first and only FDA-approved product indicated to treat hypotrichosis of the eyelashes by increasing their growth, including length, fullness, and darkness.

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Page 4: Pirch_Latisse Core Deck Final

LATISSE® (bimatoprost ophthalmic solution) 0.03% is the first and only FDA-approved product indicated to treat hypotrichosis of the eyelashes by increasing their growth, including length, fullness, and darkness.

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A total of 607 female patients with inadequate or not enough lashes participated in 3 LATISSE® (bimatoprost ophthalmic solution) 0.03% controlled clinical studies. Pooled data from these women suggest fullness, length, and darkness are inversely correlated with age.1,2

These pooled data are from 3 LATISSE® clinical studies, including the US pivotal clinical study. Eyelash fullness, length, and darkness by age in the pivotal study are consistent with the data displayed here.

Digital image analysis (DIA) fullness data were evaluable in 468 of 607 clinical studyDigital image analysis (DIA) fullness data were evaluable in 468 of 607 clinical study participants.1,2 Upper eyelash fullness was measured in pixels within the area of interest (AOI) and was additionally measured in terms of mm2. DIA length data were calculated for all 607 participants. Upper eyelash length was measured in pixels within the AOI and was additionally measured in terms of mm. DIA darkness (intensity) data were evaluable in 568 of the 607 subjects. Upper eyelash darkness was measured as intensity. The mean intensity of each pixel blob was interpreted on an 8-bit image grayscale on the continuum of 0 (black) to 255 (white) 1,20 (black) to 255 (white).1,2

References

1. Data on file, Allergan, Inc., 2008; Studies No. 192024-032, -038, -051: Digital Image Analysis at Baseline.

2. Data on file, Allergan, Inc., 2011; Pooled Baseline Analyses Memo.

3. Data on file, Allergan, Inc., 2012; Epidemiologic Analysis of Change in Eyelash Characteristics with Increasing Age in a Population of Healthy Women, GMA-LTS-11-003.

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A total of 607 female patients with inadequate or not enough lashes participated in 3 LATISSE® (bimatoprost ophthalmic solution) 0.03% controlled clinical studies. Pooled data from these women suggest fullness, length, and darkness are inversely correlated with age.1,2

These pooled data are from 3 LATISSE® clinical studies, including the US pivotal clinical study. Eyelash fullness by age data in the pivotal study are consistent with the data displayed here. Digital image analysis (DIA) fullness data were evaluable in 468 of 607 clinical study participants.1,2y p p

Upper eyelash thickness/fullness was measured within 3 preset rectangular areas (proximal, medial, and distal, each 300 x 25 pixels) positioned at fixed distances from a standardized point on the eyelash margin. For each superior-view image, the number of pixels representing the upper eyelashes were counted within each preset rectangular area. Eyelash thickness/fullness was assessed across both eyes as an average of the 3 rectangular areas (ie, average progressive eyelash thickness), individually for the 3 areas (proximal medial and distal) within the full area of interest (AOI) and within the spline (a(proximal, medial, and distal), within the full area of interest (AOI), and within the spline (a narrow area approximately 5 pixels wide, bisecting the AOI). Upper eyelash thickness/fullness was additionally measured in terms of mm2.3

References

1. Data on file, Allergan, Inc., 2008; Studies No. 192024-032, -038, -051: Digital Image Analysis at Baseline.

2. Data on file, Allergan, Inc., 2011; Pooled Baseline Analyses Memo.

3. Data on file, Allergan, Inc., 2008; Study No. 192042-032.

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A total of 607 female patients with inadequate or not enough lashes participated in 3 LATISSE® (bimatoprost ophthalmic solution) 0.03% controlled clinical studies. Pooled data from these women suggest fullness, length, and darkness are inversely correlated with age.1,2

These pooled data are from 3 LATISSE® clinical studies, including the US pivotal clinical study. Eyelash length by age data in the pivotal study are consistent with the data displayed here. Length data were calculated for all 607 participants.1,2

Upper eyelash length was measured within a defined eyelash boundary for each eyeUpper eyelash length was measured within a defined eyelash boundary for each eye, known as the full area of interest (AOI). The AOI was divided into vertical segments, with maximum upper eyelash length (defined as the maximum height of each segment) measured in pixels. The mean number of pixels over all segments represented the upper eyelash length and was computed for each digital image across both eyes. Upper eyelash length was additionally measured in terms of mm.3

References

1. Data on file, Allergan, Inc., 2008; Studies No. 192024-032, -038, -051: Digital Image Analysis at Baseline.

2. Data on file, Allergan, Inc., 2011; Pooled Baseline Analyses Memo.

3. Data on file, Allergan, Inc., 2008; Study No. 192042-032.

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A total of 607 female patients with inadequate or not enough lashes participated in 3 LATISSE® (bimatoprost ophthalmic solution) 0.03% controlled clinical studies. Pooled data from these women suggest fullness, length, and darkness are inversely correlated with age.1,2

These pooled data are from 3 LATISSE® clinical studies, including the US pivotal clinical study. Eyelash darkness by age in the pivotal study are consistent with the data displayed here. Digital image analysis (DIA) darkness data were evaluable in 568 of the 607 subjects.1,2

Upper eyelash darkness was determined by lash intensity within the full area of interest (AOI) and within the spline. Darkness (intensity) of each pixel blob (a continuous collection of pixels that are touching) was reported as mean intensity on the red, green, and blue scale. The mean intensity of each pixel blob was then interpreted on an 8-bit image grayscale on the continuum of 0 (black) and 255 (white). The mean lash intensity was the

i t iti f ll i l bl b d f l h d k 3average intensities of all pixel blobs and was a measure of upper eyelash darkness.3

References

1. Data on file, Allergan, Inc., 2008; Studies No. 192024-032, -038, -051: Digital Image Analysis at Baseline.

2 Data on file Allergan Inc 2011; Pooled Baseline Analyses Memo2. Data on file, Allergan, Inc., 2011; Pooled Baseline Analyses Memo.

3. Data on file, Allergan, Inc., 2008; Study No. 192042-032.

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There is significant opportunity to discuss hypotrichosis, since only 21% of MDs are currently discussing eyelash changes.

Reference1. Data on file, Allergan, Inc., 2008; LATISSE® Professional A&U Q2 2012.

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The following is Important Safety Information about LATISSE® (bimatoprost ophthalmic solution) 0.03%.

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The following is Important Safety Information about LATISSE® (bimatoprost ophthalmic solution) 0.03%.

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The following is Important Safety Information about LATISSE® (bimatoprost ophthalmic solution) 0.03%. The full Prescribing Information is available at this presentation.

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It is believed that LATISSE® (bimatoprost ophthalmic solution) 0.03% exerts its effect on the growth of eyelashes by increasing the percentage of hairs in, and the duration of, anagen(or the growth phase).1 LATISSE® solution likely increases melanin synthesis, resulting indarker hair pigmentation. The exact mechanism of action is unknown.1

References

1. LATISSE® [package insert]. Irvine, CA: Allergan, Inc., 2012.[p g ] , g , ,

2. Johnstone MA, Albert DM. Prostaglandin-induced hair growth. Surv Ophthalmol. 2002;47(suppl 1):S185-S202.

3. Elder MJ. Anatomy and physiology of eyelash follicles: relevance to lash ablation procedures. OphthalPlast Reconstr Surg. 1997;13(1):21-25.

4. Na JI, Kwon OS, Kim BJ, et al. Ethnic characteristics of eyelashes: a comparative analysis in Asian and Caucasian females. Br J Dermatol. 2006;155(6):1170-1176.

5 Data on file Allergan Inc 2008; Study No 192024 0325. Data on file, Allergan, Inc., 2008; Study No. 192024-032.

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Reference

1. Data on file, Allergan, Inc., 2008; Study No. 192024-032: Demographics and Baseline Characteristics.

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The primary efficacy endpoint for the pivotal clinical study was defined as at least a 1-grade increase on the GEA scale,* a photonumeric rating scale, from week 0 to week 16. Overall eyelash prominence was graded from 1 (minimal eyelash prominence) through 4 (very marked eyelash prominence), by evaluating elements of length, fullness, and darkness of both sets of upper eyelashes.

A statistically significantly higher percentage of patients in the LATISSE® (bimatoprost ophthalmic solution) 0.03% group (78.1%, 107/137) compared with the vehicle group (18.4%, 26/141) experienced at least a 1-grade increase from baseline in overall eyelash prominence as rated by p g y p ythe GEA scale at week 16 (P < .0001). By week 8, 50% of LATISSE® patients saw results vs 15% for vehicle patients. Percentage changes are noted in the chart above thedata points.

*Patent pending.

R fReferences

1. LATISSE® [package insert]. Irvine, CA: Allergan, Inc., 2012.

2. Data on file, Allergan, Inc., 2008; Study No. 192024-032.

3. Smith S, Fagien S, Whitcup SM, et al. Eyelash growth in subjects treated with bimatoprost: a multicenter, randomized, double-masked, vehicle-controlled, parallel-group study. J Am Acad Dermatol. 2012;66(5):801-806.

4. Yoelin S, Wu J, Somogyi C, Beddingfield FC III. Inter-rater and intra-rater reliability of the Global Eyelash oe S, u J, So ogy C, edd g e d C e a e a d a a e e ab y o e G oba ye asAssessment scale for assessment of overall eyelash prominence. Poster presented at: 33rd Annual Hawaii Dermatology Seminar of the Skin Disease Education Foundation; February 7-13, 2009; Maui, HI.

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During the clinical trial, the secondary efficacy measurements collected in the study included eyelash length, progressive eyelash thickness/fullness, and eyelash darkness(intensity) at 16 weeks.1

Reference

1. Data on file, Allergan, Inc., 2008; Study No. 192024-032.

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In the LATISSE® (bimatoprost ophthalmic solution) 0.03% pivotal clinical trial, a statistically significant increase in fullness/thickness was seen as early as week 8(P ≤ .0004). A statistically significant difference was maintained for the duration of the treatment. By week 16, the percentage change from baseline was 106% for LATISSE®

patients and 12% for vehicle (P < .0001).

Percentage changes are noted in the chart above the data points.1,2

Individual results may vary. If discontinued, lashes will gradually return to theirprevious appearanceprevious appearance.

Patients should also be informed of the possibility of disparity between eyes in length, thickness, pigmentation, number of eyelashes or vellus hairs, and/or direction of eyelash growth.

References

1. LATISSE® [package insert]. Irvine, CA: Allergan, Inc., 2012.

2. Data on file, Allergan, Inc., 2008; Study No. 192024-032.

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In the LATISSE® (bimatoprost ophthalmic solution) 0.03% pivotal clinical trial, a statistically significant increase in length was seen as early as week 4 (P = .0025). A statistically significant difference was maintained for the duration of the treatment. By week 16, the percentage change from baseline was 25% for LATISSE® patients and 2% for vehicle (P < .0001). Percentage changes are noted in the chart above the data points.1,2

Individual results may vary. If discontinued, lashes will gradually return to their previous appearance.

Patients should also be informed of the possibility of disparity between eyes in lengthPatients should also be informed of the possibility of disparity between eyes in length, thickness, pigmentation, number of eyelashes or vellus hairs, and/or direction of eyelash growth.

References

1. LATISSE® [package insert]. Irvine, CA: Allergan, Inc., 2012.

2. Data on file, Allergan, Inc., 2008; Study No. 192024-032.

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In the LATISSE® (bimatoprost ophthalmic solution) 0.03% pivotal clinical trial, a statistically significant increase in darkness was seen as early as week 8 (P < .0001). A statistically significant difference was maintained for the duration of the treatment. By week 16, the percentage change from baseline was 18% for LATISSE® patients and 3% for vehicle (P < .0001). Percentage changes are noted in the chart above the data points.1,2

Individual results may vary. If discontinued, lashes will gradually return to their previous appearance.

Patients should also be informed of the possibility of disparity between eyes in lengthPatients should also be informed of the possibility of disparity between eyes in length, thickness, pigmentation, number of eyelashes or vellus hairs, and/or direction of eyelash growth.

References

1. LATISSE® [package insert]. Irvine, CA: Allergan, Inc., 2012.

2. Data on file, Allergan, Inc., 2008; Study No. 192024-032.

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The most commonly affected system organ class was the eye, with adverse events of the eye reported by 20.4% (28/137) and 11.3% (16/141) of subjects in the LATISSE® (bimatoprost ophthalmic solution) 0.03% and vehicle groups, respectively (P = .038).1

These adverse events included eye pruritus, conjunctival hyperemia, skin hyperpigmentation, ocular irritation, dry eye, and erythema of the eyelid.

Conjunctival hyperemia was the only adverse event to be reported by a statistically significantly higher number of subjects in the LATISSE® treated group compared with the vehicle group(P 028) All cases of conjunctival hyperemia were fully resolved by the end of the study(P = .028). All cases of conjunctival hyperemia were fully resolved by the end of the study.

LATISSE® solution adverse events are related to the pharmacological effects of bimatoprost.

• Conjunctival hyperemia: vasodilation

• Hyperpigmentation: increases in melanin with no cell proliferation or atypia

All of the treatment-related adverse events reported by subjects in the LATISSE® treated group were mild in severity, except for one incidence of contact dermatitis and one of dry eye, both beingmild in severity, except for one incidence of contact dermatitis and one of dry eye, both being described as moderate. All treatment-related adverse events reported by subjects in the vehicle group were mild in severity, except for one incidence of severe IOP reduction, which resulted in study discontinuation.

References

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1. LATISSE® [package insert]. Irvine, CA: Allergan, Inc., 2012.

2. Data on file, Allergan, Inc., 2008; Study No. 192024-032.

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Reference

1. LATISSE® [package insert]. Irvine, CA: Allergan, Inc.; 2012.

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• Subjects were instructed to carefully apply one drop of study medication to a disposable single-use-per-eye applicator and brush it along the upper eyelid margin once daily

• Subjects were instructed to repeat for the opposite eyelid margin using a new sterile applicator

• They were also instructed not to apply study medication to the lower eyelash line

• If excess study medication came off the lid, subjects were instructed to dab or blot any excess study medication with a tissuey

• Study medication was applied on a clean face after all makeup was removed and after any other facial-care products were applied (eg, lotion)

• Subjects were instructed to remove contact lenses before applying study medication and keep them out for at least 15 minutes

• Applying bimatoprost solution more than once a day will not increase the growth of eyelasheseyelashes

• Don’t allow the tip of the bottle or applicator to touch fingers or any other unintended surface, as contamination by common bacteria is known to cause infections

• Remember, if you stop using LATISSE®, lashes will gradually return to their previous appearance

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Reference

1. LATISSE® [package insert]. Irvine, CA: Allergan, Inc., 2012.

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In an ocular splash experiment, a drop of LATISSE® (bimatoprost ophthalmic solution) 0.03% was instilled directly into one eye and the same volume was applied to the upper eyelid margin of the other eye via the applicator in a LATISSE® kit.1 The images demonstrate the amount of solution near the eye when applied as an eyedrop vs dermal application to the upper eyelid margin. The results reinforce how important it is for patients to apply LATISSE® to the upper eyelid margin with the provided FDA-approved sterile applicators.

Lissamine green 28- to 30-uL drop size, produced by placing sterile saline onto sterile strip.

For dermal application a 28 to 30 uL drop of lissamine green dye was placed using sterile salineFor dermal application, a 28- to 30-uL drop of lissamine green dye was placed using sterile saline onto a sterile strip, then transferred to a sterile brush. The brush was handed to the subject for self-application, and postdose photos were taken.

For direct ocular application, lissamine green was applied via a strip and applied to the eye using standard clinical technique. The subject was instructed to blink, and postdose photos were taken.

The volume of bimatoprost when applied to the eyelid margin with the applicator is approximately5% of the volume used as an eyedrop5% of the volume used as an eyedrop.

References

1. Fagien S. Management of hypotrichosis of the eyelashes: Focus on bimatoprost. Clin Cosmet InvestigDermatol. 2010;3:39-48.

2. Dermatologic and Ophthalmic Drug Advisory Committee Briefing Document for New Drug Application (NDA) 22 369 Bi t t S l ti 0 03% f th I t f N t l E l h P i

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(NDA) 22-369. Bimatoprost Solution 0.03% for the Improvement of Natural Eyelash Prominence. http://www.fda.gov/ohrms/dockets/AC/08/briefing/2008-4397b1-04-Allergan.pdf. Published October 29, 2008. Accessed March 19, 2012.

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Now that we’ve discussed the efficacy and safety of LATISSE® (bimatoprost ophthalmic solution) 0.03%, here are photos showing the results obtained in the clinical study. You can present this 16-week timeline of results to patients to help manage their expectations.

Individual results may vary. This timeline is provided in the Staff Consult Guide and on the LATISSE® website for healthcare professionals at professional.latisse.com.

Upon discontinuation of treatment, eyelash growth is expected to return to its pretreatment level.

Patients should be informed of the possibility of disparity between eyes in length, thickness, pigmentation, number of eyelashes or vellus hairs, and/or direction of eyelash growth.

References

1. LATISSE® [package insert]. Irvine, CA: Allergan, Inc., 2012.

2. Data on file, Allergan, Inc., 2008; Study No. 192024-032.

3. Smith S, Fagien S, Whitcup SM, et al. Eyelash growth in subjects treated with bimatoprost: a multicenter, randomized, double-masked, vehicle-controlled, parallel-group study. J Am Acad Dermatol. 2012;66(5):801-806.

4. Yoelin S, Wu J, Somogyi C, Beddingfield FC III. Inter-rater and intra-rater reliability of the Global Eyelash Assessment scale for assessment of overall eyelash prominence. Poster presented at: 33rd Annual Hawaii Dermatology Seminar of the Skin Disease Education Foundation; February 7-13, 2009; Maui, HI.Foundation; February 7 13, 2009; Maui, HI.

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Page 27: Pirch_Latisse Core Deck Final

Now that we’ve discussed the efficacy and safety of LATISSE® (bimatoprost ophthalmic solution) 0.03%, here are photos showing the results obtained in the clinical study. You can present this 16-week timeline of results to patients to help manage their expectations.

Individual results may vary. This timeline is provided in the Staff Consult Guide and on the LATISSE® website for healthcare professionals at professional.latisse.com.

Upon discontinuation of treatment, eyelash growth is expected to return to its pretreatment level.

Patients should be informed of the possibility of disparity between eyes in length, thickness, pigmentation, number of eyelashes or vellus hairs, and/or direction of eyelash growth.

References

1. LATISSE® [package insert]. Irvine, CA: Allergan, Inc., 2012.

2. Data on file, Allergan, Inc., 2008; Study No. 192024-032.

3. Smith S, Fagien S, Whitcup SM, et al. Eyelash growth in subjects treated with bimatoprost: a multicenter, randomized, double-masked, vehicle-controlled, parallel-group study. J Am Acad Dermatol. 2012;66(5):801-806.

4. Yoelin S, Wu J, Somogyi C, Beddingfield FC III. Inter-rater and intra-rater reliability of the Global Eyelash Assessment scale for assessment of overall eyelash prominence. Poster presented at: 33rd Annual Hawaii Dermatology Seminar of the Skin Disease Education Foundation; February 7-13, 2009; Maui, HI.Foundation; February 7 13, 2009; Maui, HI.

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Page 28: Pirch_Latisse Core Deck Final

Now that we’ve discussed the efficacy and safety of LATISSE® (bimatoprost ophthalmic solution) 0.03%, here are photos showing the results obtained in the clinical study. You can present this 16-week timeline of results to patients to help manage their expectations.

Individual results may vary. This timeline is provided in the Staff Consult Guide and on the LATISSE® website for healthcare professionals at professional.latisse.com.

Upon discontinuation of treatment, eyelash growth is expected to return to its pretreatment level.

Patients should be informed of the possibility of disparity between eyes in length, thickness, pigmentation, number of eyelashes or vellus hairs, and/or direction of eyelash growth.

References

1. LATISSE® [package insert]. Irvine, CA: Allergan, Inc., 2012.

2. Data on file, Allergan, Inc., 2008; Study No. 192024-032.

3. Smith S, Fagien S, Whitcup SM, et al. Eyelash growth in subjects treated with bimatoprost: a multicenter, randomized, double-masked, vehicle-controlled, parallel-group study. J Am Acad Dermatol. 2012;66(5):801-806.

4. Yoelin S, Wu J, Somogyi C, Beddingfield FC III. Inter-rater and intra-rater reliability of the Global Eyelash Assessment scale for assessment of overall eyelash prominence. Poster presented at: 33rd Annual Hawaii Dermatology Seminar of the Skin Disease Education Foundation; February 7-13, 2009; Maui, HI.Foundation; February 7 13, 2009; Maui, HI.

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To get your office started with LATISSE® (bimatoprost ophthalmic solution) 0.03%, we have several resources available at professional.latisse.com.

Office assets are available at Allergan BrandBox, a resource for product and before-and-after images for your website or other practice marketing materials. You’ll also find printable PDFs of office materials such as a patient brochure and display pieces for your waiting room and consultation rooms.

We also offer LashLiaisons, an online course where staff members can learn about how lashes may thin with age and the role of LATISSE® (bimatoprost ophthalmic solution)lashes may thin with age and the role of LATISSE® (bimatoprost ophthalmic solution) 0.03% in treating hypotrichosis. With their knowledge, staff members will be able to start conversations with patients, answer frequently asked questions, explain safety information, and more.

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References1. Data on file, Allergan, Inc., 2008; Studies No. 192024-032, 192024-038, 192024-051:

Digital Image Analysis at Baseline. 2. Data on file, Allergan, Inc., 2011; Pooled Baseline Analyses Memo. 3. LATISSE® [package insert]. Irvine, CA: Allergan, Inc. 2012.4. Data on file, Allergan, Inc., 2008; Study No. 192024-032: Full Clinical Study Report. 5. Smith S, Fagien S, Whitcup SM, et al. Eyelash growth in subjects treated with

bimatoprost: a multicenter, randomized, double-masked, vehicle-controlled, parallel-t d J A A d D t l 2012 66(5) 801 806group study. J Am Acad Dermatol. 2012;66(5):801-806.

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