Safety, Effectiveness, and Safety, Effectiveness, and Subjective Experience With Subjective Experience With Topical Bimatoprost 0.03% for Topical Bimatoprost 0.03% for Eyelash Growth Eyelash Growth Steven G. Yoelin, MD, John G. Walt, MBA Steven G. Yoelin, MD, John G. Walt, MBA Financial disclosures: Financial disclosures: Steven G. Yoelin, MD, received an unrestricted research grant from Steven G. Yoelin, MD, received an unrestricted research grant from Allergan, Inc. to support the study. Allergan, Inc. to support the study. John G. Walt is Health Outcomes Researcher at Allergan, Inc. John G. Walt is Health Outcomes Researcher at Allergan, Inc.
Transcript
Safety, Effectiveness, and Subjective Safety, Effectiveness, and Subjective Experience With Topical Bimatoprost Experience With Topical Bimatoprost 0.03% for Eyelash Growth0.03% for Eyelash Growth
Steven G. Yoelin, MD, John G. Walt, MBASteven G. Yoelin, MD, John G. Walt, MBA
Financial disclosures:Financial disclosures:
Steven G. Yoelin, MD, received an unrestricted research grant from Allergan, Inc. to support the Steven G. Yoelin, MD, received an unrestricted research grant from Allergan, Inc. to support the study.study.John G. Walt is Health Outcomes Researcher at Allergan, Inc.John G. Walt is Health Outcomes Researcher at Allergan, Inc.
Eyelashes help protect the eye Eyelashes help protect the eye from debris and excessive from debris and excessive sunlight sunlight
Eyelash prominence has been Eyelash prominence has been described as having a positive described as having a positive psychological effectpsychological effect1,21,2
– Prominent eyelashes are widely Prominent eyelashes are widely considered to be a desirable considered to be a desirable physical attributephysical attribute1,21,2
– Eyelash prominence is defined Eyelash prominence is defined by length, fullness (thickness), by length, fullness (thickness), and darkness (intensity) based and darkness (intensity) based on a validated measureon a validated measure33
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.
Background: Bimatoprost Ophthalmic Background: Bimatoprost Ophthalmic Solution 0.03% for Eyelash GrowthSolution 0.03% for Eyelash Growth Bimatoprost is a structural prostaglandin Bimatoprost is a structural prostaglandin
analoganalog11
– Prostaglandins act as local regulators that Prostaglandins act as local regulators that mediate a variety of physiological functions, mediate a variety of physiological functions, including vasoconstriction/vasodilation, including vasoconstriction/vasodilation, platelet aggregation, and bronchoconstriction/ platelet aggregation, and bronchoconstriction/ bronchodilationbronchodilation22
Bimatoprost likely penetrates the hair follicle Bimatoprost likely penetrates the hair follicle via the dermisvia the dermis
– Physicochemical properties favor its effective Physicochemical properties favor its effective skin absorption to the dermis where hair skin absorption to the dermis where hair follicles residefollicles reside
– Eyelid-margin application delivers approximately Eyelid-margin application delivers approximately 5% of the applied dose compared with an 5% of the applied dose compared with an eyedropeyedrop33
Long-term safety profile of bimatoprost Long-term safety profile of bimatoprost ophthalmic solution 0.03% has been ophthalmic solution 0.03% has been established since its approval in the United established since its approval in the United States (March 2001) for the treatment of States (March 2001) for the treatment of elevated intraocular pressure/ocular elevated intraocular pressure/ocular hypertensionhypertension4-64-6
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. Surv Ophthalmol. 2004;49:S45-S52; 6. Williams RD et al.Br J Ophthalmol. 2008;92:1387-1382.
Molecular Structure of Bimatoprost
Background: Mechanism of Action HypothesisBackground: Mechanism of Action Hypothesis
Increases the percent of eyelashes in anagenIncreases the percent of eyelashes in anagen11
Prolongs anagen5
Normal Eyelash Cycle2-4 Effect of Bimatoprost Ophthalmic Solution 0.03%
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.
~1-2 months
~15 days
~5 months(4-9 months)
Stimulates transition from telogen to anagen5
ObjectiveObjective
To investigate the safety, efficacy and subjective To investigate the safety, efficacy and subjective experience of bimatoprost ophthalmic solution 0.03% for experience of bimatoprost ophthalmic solution 0.03% for the treatment of hypotrichosis*the treatment of hypotrichosis*
*Hypotrichosis is another name for having inadequate or not enough eyelashes.
Methods: Study DesignMethods: Study Design
A prospective, open-label study of healthy female subjects who desired A prospective, open-label study of healthy female subjects who desired longer, thicker (fuller), and darker natural eyelasheslonger, thicker (fuller), and darker natural eyelashes– Subjects were at least 18 years old, and had an intraocular pressure (IOP) no Subjects were at least 18 years old, and had an intraocular pressure (IOP) no
higher than 22 mm Hghigher than 22 mm Hg
Subjects were instructed to apply bimatoprost ophthalmic solution 0.03% Subjects were instructed to apply bimatoprost ophthalmic solution 0.03% bilaterally to the upper eyelid margin once daily for 12 weeksbilaterally to the upper eyelid margin once daily for 12 weeks– Subjects were instructed to wipe the areas immediately around the eyelid Subjects were instructed to wipe the areas immediately around the eyelid
afterward to remove excess medicationafterward to remove excess medication
All subjects (16/16) indicated that their eyelashes were All subjects (16/16) indicated that their eyelashes were “improved” or “much improved” compared to before “improved” or “much improved” compared to before treatmenttreatment
Most subjects (94%; 15/16) “much” or “very much” Most subjects (94%; 15/16) “much” or “very much” agreed that bimatoprost ophthalmic solution 0.03% was agreed that bimatoprost ophthalmic solution 0.03% was helpful and that they had done something positive for helpful and that they had done something positive for their appearance (75%; 12/16)their appearance (75%; 12/16)
All subjects agreed that they felt more attractive at the All subjects agreed that they felt more attractive at the end of the treatment periodend of the treatment period
Results: Bimatoprost Ophthalmic Solution Results: Bimatoprost Ophthalmic Solution 0.03% Was Generally Well Tolerated0.03% Was Generally Well Tolerated
Common AEs reported: eye redness, pigmentation changes or Common AEs reported: eye redness, pigmentation changes or redness, mild itchiness, burning, eye drynessredness, mild itchiness, burning, eye dryness
No AEs resulted in study discontinuationNo AEs resulted in study discontinuation
No serious or unexpected AEs were reported No serious or unexpected AEs were reported
Skin darkening in the general application area was noted at least Skin darkening in the general application area was noted at least once for 5 subjects once for 5 subjects – For 4 subjects: noted as “possible,” “slight,” “small,” or “a little” For 4 subjects: noted as “possible,” “slight,” “small,” or “a little”
– For 1 subject: noted as “yes”For 1 subject: noted as “yes”
Hyperemia not observed on biomicroscopy at any visitHyperemia not observed on biomicroscopy at any visit
No AEs related to visual acuity or IOPNo AEs related to visual acuity or IOP– Mean changes from baseline <1 mm Hg at any time point, indicating Mean changes from baseline <1 mm Hg at any time point, indicating
The increased growth correlated with increased The increased growth correlated with increased patient satisfactionpatient satisfaction
Bimatoprost ophthalmic solution 0.03% was generally Bimatoprost ophthalmic solution 0.03% was generally well toleratedwell tolerated
Bimatoprost ophthalmic solution 0.03% is the first and Bimatoprost ophthalmic solution 0.03% is the first and only treatment approved by the US Food and Drug only treatment approved by the US Food and Drug Administration indicated to treat hypotrichosis of the Administration indicated to treat hypotrichosis of the eyelashes by increasing their growth including length, eyelashes by increasing their growth including length, thickness, and darknessthickness, and darkness
