Safety, Effectiveness, and Subjective Experience With Topical Bimatoprost 0.03% for Eyelash Growth

1. Safety, Effectiveness, and Subjective Experience With Topical Bimatoprost 0.03% for Eyelash Growth Steven G. Yoelin, MD, John G. Walt, MBA Financial disclosures: Steven G. Yoelin, MD, received an unrestricted research grant from Allergan, Inc. to support the study. John G. Walt is Health Outcomes Researcher at Allergan, Inc.

2. Background: Eyelash Functions • Eyelashes help protect the eye from debris and excessive sunlight • Eyelash prominence has been described as having a positive psychological effect1,2 • Prominent eyelashes are widely considered to be a desirable physical attribute1,2 • Eyelash prominence is defined by length, fullness (thickness), and darkness (intensity) based on a validated measure3 1. Holló G. Expert Opin Drug Saf. 2007;6:45-52; 2. Batchelor D. Eur J Cancer Care (Engl). 2001;10:147-163, 3. Yoelin S et al. Poster presented at: 33rd Hawaii Dermatology Seminar; February 7-13, 2009; Wailea, Hawaii.

3. Background: Bimatoprost Ophthalmic Solution 0.03% for Eyelash Growth • Bimatoprost is a structural prostaglandin analog1 • Prostaglandins act as local regulators that mediate a variety of physiological functions, including vasoconstriction/vasodilation, platelet aggregation, and bronchoconstriction/ bronchodilation2 • Bimatoprost likely penetrates the hair follicle via the dermis • Physicochemical properties favor its effective skin absorption to the dermis where hair follicles reside • Eyelid-margin application delivers approximately 5% of the applied dose compared with an eyedrop3 • Long-term safety profile of bimatoprost ophthalmic solution 0.03% has been established since its approval in the United States (March 2001) for the treatment of elevated intraocular pressure/ocular hypertension4-6 Molecular Structure of Bimatoprost 1. LATISSE™ [package insert]. Irvine, CA: Allergan, Inc.; 2008; 2. Smyth EN et al. In: Brunton LL et al, eds. Goodman & Gilman’sThe Pharmacological Basis of Therapeutics. 11th ed. New York, NY; McGraw-Hill Companies, Inc: 2006; 3. Data on file. Allergan Inc.; 4. Higginbotham EJ et al. Arch Ophthalmol. 2002;120:1286-1293; 5. Cohen JS et al. SurvOphthalmol. 2004;49:S45-S52; 6. Williams RD et al.Br J Ophthalmol. 2008;92:1387-1382.

4. Background: Mechanism of Action Hypothesis • Increases the percent of eyelashes in anagen1 Normal Eyelash Cycle2-4 Effect of Bimatoprost Ophthalmic Solution 0.03% ~5 months(4-9 months) Stimulates transition from telogen to anagen5 ~15 days Prolongs anagen5 ~1-2 months 1. LATISSE™ [package insert]. Irvine, CA: Allergan, Inc.; 2008; 2. Johnstone MA, Albert DM. Surv Ophthalmol. 2002;47(suppl 1):S185-S202; 3. Elder MJ. Ophthal Plast Reconstr Surg. 1997;13:21-25; 4. Na JI et al. Br J Derm. 2006;155:1170-1176; 5. Data on file. Allergan Inc.

5. Objective • To investigate the safety, efficacy and subjective experience of bimatoprost ophthalmic solution 0.03% for the treatment of hypotrichosis* *Hypotrichosis is another name for having inadequate or not enough eyelashes.

6. Methods: Study Design • A prospective, open-label study of healthy female subjects who desired longer, thicker (fuller), and darker natural eyelashes • Subjects were at least 18 years old, and had an intraocular pressure (IOP) no higher than 22 mm Hg • Subjects were instructed to apply bimatoprost ophthalmic solution 0.03% bilaterally to the upper eyelid margin once daily for 12 weeks • Subjects were instructed to wipe the areas immediately around the eyelid afterward to remove excess medication • Safety measures • Adverse events (AEs) • Visual acuity • IOP • Biomicroscopy • Periorbital darkening • Efficacy measure • Patient satisfaction questionnaire

7. Results: Patient Demographics • Enrolled population: 28 subjects • 100% female • 96% Caucasian • Average age of 49 years (range: 32 to 73) • In good health • 22 subjects completed the study

8. Results: Subject Reported Eyelash Improvement and Onset of Action Subject-Reported Effectivenessat Week 12 Subject-Reported Onset of Improvement Subjects Responding (%) Subjects Responding (%) Change in Eyelashes From Baseline Time of Onset

9. Results: Representative Eyelash Effects with Bimatoprost Ophthalmic Solution 0.03% Pretreatment Bimatoprost 0.03% Photographs courtesy of Steve Yoelin, MD.

10. Results: Patient Satisfaction Within 3 months • All subjects (16/16) indicated that their eyelashes were “improved” or “much improved” compared to before treatment • Most subjects (94%; 15/16) “much” or “very much” agreed that bimatoprost ophthalmic solution 0.03% was helpful and that they had done something positive for their appearance (75%; 12/16) • All subjects agreed that they felt more attractive at the end of the treatment period

11. Results: Bimatoprost Ophthalmic Solution 0.03% Was Generally Well Tolerated • Common AEs reported: eye redness, pigmentation changes or redness, mild itchiness, burning, eye dryness • No AEs resulted in study discontinuation • No serious or unexpected AEs were reported • Skin darkening in the general application area was noted at least once for 5 subjects • For 4 subjects: noted as “possible,” “slight,” “small,” or “a little” • For 1 subject: noted as “yes” • Hyperemia not observed on biomicroscopy at any visit • No AEs related to visual acuity or IOP • Mean changes from baseline <1 mm Hg at any time point, indicating no clinical significance

12. Conclusions • Bimatoprost ophthalmic solution 0.03% increased growth of natural eyelashes • The increased growth correlated with increased patient satisfaction • Bimatoprost ophthalmic solution 0.03% was generally well tolerated • Bimatoprost ophthalmic solution 0.03% is the first and only treatment approved by the US Food and Drug Administration indicated to treat hypotrichosis of the eyelashes by increasing their growth including length, thickness, and darkness