Download Safety, Effectiveness, and Subjective Experience With Topical

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.
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.
Background: Bimatoprost Ophthalmic
Solution 0.03% for Eyelash Growth

Bimatoprost is a structural prostaglandin
analog1
–

Molecular Structure of
Bimatoprost
Bimatoprost likely penetrates the hair follicle
via the dermis
–
–

Prostaglandins act as local regulators that
mediate a variety of physiological functions,
including vasoconstriction/vasodilation,
platelet aggregation, and bronchoconstriction/
bronchodilation2
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
1. LATISSE™ [package insert]. Irvine, CA: Allergan, Inc.; 2008; 2. Smyth EN et al. In: Brunton LL et al, eds. Goodman & Gilman’s
The 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.
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
~1-2 months
Prolongs
anagen5
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.
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.
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
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
Results: Subject Reported Eyelash
Improvement and Onset of Action
100
90
80
70
60
50
40
30
20
10
0
13/16
3/16
0/16
No Change
Improved
Much
Improved
Change in Eyelashes From Baseline
Subject-Reported Onset
of Improvement
Subjects Responding (%)
Subjects Responding (%)
Subject-Reported Effectiveness
at Week 12
100
90
80
70
60
50
40
30
20
10
0
16/16
13/16
4/16
Within 1
Month
Within 2
Months
Time of Onset
Within 3
Months
Results: Representative Eyelash Effects with
Bimatoprost Ophthalmic Solution 0.03%
Pretreatment
Bimatoprost 0.03%
Photographs courtesy of Steve Yoelin, MD.
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
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
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