FDA-Approved Treatment for Eyelash Hypotrichosis

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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age.1,2
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
Baseline.
3. Data on file, Allergan, Inc., 2008; Study No. 192042-032.
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age.1,2
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
Baseline.
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age.1,2
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
Baseline.
2 Data on file Allergan Inc 2011; Pooled Baseline Analyses Memo2. Data on file, Allergan, Inc., 2011; Pooled Baseline Analyses Memo.
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There is significant opportunity to discuss hypotrichosis, since only 21% of MDs are
currently discussing eyelash changes.
Reference
1. 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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solution) 0.03%.
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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 in
darker 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. Ophthal
Plast 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 byp g y p y
the 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 the
data points.
*Patent pending.
R fReferences
1. LATISSE® [package insert]. Irvine, CA: Allergan, Inc., 2012.
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 Eyelashoe 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 as
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.
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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
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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 their
previous 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
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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,
growth.
References
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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,
growth.
References
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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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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

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 approximately
5% 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 Investig
Dermatol. 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.

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
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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level.
References
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level.
References
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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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References
1. Data on file, Allergan, Inc., 2008; Studies No. 192024-032, 192024-038, 192024-051:
Digital Image Analysis at Baseline.
3. LATISSE® [package insert]. Irvine, CA: Allergan, Inc. 2012.
4. Data on file, Allergan, Inc., 2008; Study No. 192024-032: Full Clinical Study Report.
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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