Available only through a doctor, LATISSE® is a once-daily prescription treatment
applied to the base of the upper eyelashes with a sterile, single-use-per-eye disposable
applicator. LATISSE® users can expect to experience longer, fuller and darker
eyelashes in as little as eight weeks, with full results in 16 weeks. To maintain
effect, continued treatment with LATISSE® is required. If use of LATISSE®
is discontinued, eyelashes will gradually return to where they were prior to treatment
over a period of weeks to months (average eyelash hair cycle).
Similar to Allergan's other medical aesthetic offerings, the benefits of LATISSE®
are derived from scientific evidence, its quality formulation, and medical origin.
LATISSE® was clinically tested in a pivotal Phase III, multi-center, double-masked,
placebo-controlled study to assess its safety and efficacy in which all endpoints
(improved eyelash prominence, length, thickness and darkness) were met. In addition,
like BOTOX® (botulinum toxin type A), which was first approved by
the FDA as a medical treatment for eye disorders and was later found to have an
aesthetic benefit, bimatoprost, the active ingredient in LATISSE®, was first
approved in 2001 as a medical product to lower intraocular pressure in people with
open-angle glaucoma or ocular hypertension. Patients treated with bimatoprost for
this specific eye condition experienced eyelash growth as a side effect. The long-term
safety of bimatoprost for therapeutic use has been recognized by the medical community
and well established based on use in 32 clinical trials involving more than 5,700
glaucoma patients and more than 13 years of clinical trial experience. Given the
existing and substantial clinical and post-marketing safety data with bimatoprost
solution 0.03%, coupled with the positive results from the Phase III LATISSE®
study, LATISSE® provides patients a clinically meaningful aesthetic benefit
with a favorable safety profile.
Bimatoprost is the active pharmaceutical ingredient in the formulation of LATISSE®
and is a structural prostaglandin analog, a lipid compound derived from fatty acids
designed to bind to prostaglandin (PG) receptors. PG receptors are present in hair,
particularly in the dermal papilla and outer root sheath. Although the precise mechanism
of action is unknown, PG receptors are thought to be involved in the development
and regrowth of the hair follicle,i by increasing the percent of hairs
in, and the duration of, the anagen or growth phase.
"As an oculoplastic surgeon who has treated both medical eye conditions as well
as aesthetic needs, I have extensive knowledge of and experience with the established
therapeutic safety profile for bimatoprost," said Steven Fagien, M.D., F.A.C.S.,
in private practice at Aesthetic Eyelid Plastic Surgery in Boca Raton, Florida,
and LATISSE® clinical investigator. "In the clinical study with LATISSE®,
I observed statistically significant differences in eyelash growth and resulting
patient satisfaction. Now that LATISSE® is FDA approved, I look forward to
prescribing it to my patients who will enjoy the benefits of more prominent eyelashes
while I remain confident in the treatment's favorable safety profile."
LATISSE® will be available in the United States by prescription only and is
subject to all U.S. guidelines applicable to dispensing a prescription product.
Based on today's FDA approval, Allergan expects to launch the product nationwide
in the first quarter of 2009. Doctors and consumers are encouraged to visit www.latisse.com for further product
and prescribing information.
Allergan estimates global peak sales of LATISSE® could exceed $500 million
per year. As the exclusive U.S. and foreign patent owner, Allergan obtains the rights
to the use of bimatoprost and other prostaglandins and prostaglandin analogs as
a treatment to stimulate eyelash growth.
LATISSE® Clinical Development Program
In the pivotal Phase III study, 278 healthy adult patients with no active ocular
disease and with baseline minimal or moderate eyelash prominence were randomized
to apply either LATISSE® or vehicle to both upper eyelid margins once daily
for 16 weeks. The primary efficacy endpoint was overall eyelash prominence at the
end of the 16-week treatment period as measured by a ≥1-grade improvement on a 4-point
Global Eyelash Assessment Scale. Secondary efficacy endpoints were eyelash length,
thickness, and darkness as determined by Digital Image Analysis of patient photographs
taken in a standardized manner.
All of the endpoints in the LATISSE® pivotal trial were met. By the end of
the 16-week treatment period, patients treated with LATISSE® experienced statistically
significant greater improvement (p < 0.0001 for each endpoint) than those in the
vehicle group in the measurements of eyelash prominence, length, thickness and darkness.
LATISSE® was also well tolerated with the most commonly reported adverse events
being non-serious and cosmetic in nature. Common adverse events observed in the
clinical trial included eye redness (3.6%), itchy eyes (3.6%) and skin hyperpigmentation
(2.9%).
Important LATISSE® Safety Information
LATISSE® solution is intended for use on the skin of the upper eyelid margins
at the base of the eyelashes. DO NOT APPLY to the lower eyelid. If you are using
LUMIGAN® or other products in the same class for elevated intraocular
pressure (IOP), or if you have a history of abnormal IOP, you should only use LATISSE®
under the close supervision of your doctor.
LATISSE® use may cause darkening of the eyelid skin which may be reversible.
Although not reported in clinical studies, LATISSE® use may also cause increased
brown pigmentation of the colored part of the eye which is likely to be permanent.
It is possible for hair growth to occur in other areas of your skin that LATISSE®
frequently touches. Any excess solution outside the upper eyelid margin should be
blotted with a tissue or other absorbent material to reduce the chance of this from
happening. It is also possible for a difference in eyelash length, thickness, fullness,
pigmentation, number of eyelash hairs, and/or direction of eyelash growth to occur
between eyes. These differences, should they occur, will usually go away if you
stop using LATISSE®.
The most common side effects after using LATISSE® solution are an itching
sensation in the eyes and/or eye redness. This was reported in approximately 4%
of patients. LATISSE® solution may cause other less common side effects which
typically occur on the skin close to where LATISSE® is applied, or in the
eyes. These include skin darkening, eye irritation, dryness of the eyes, and redness
of the eyelids.
If you develop a new ocular condition (e.g., trauma or infection), experience a
sudden decrease in visual acuity, have ocular surgery, or develop any ocular reactions,
particularly conjunctivitis and eyelid reactions, you should immediately seek your
doctor's advice concerning the continued use of LATISSE® solution.
Full prescribing information is available at www.latisse.com and www.allergan.com.
Important BOTOX® and BOTOX® Cosmetic (Botulinum
Toxin Type A) Information
BOTOX® is approved for the treatment of cervical dystonia in adults
to decrease the severity of abnormal head position and neck pain associated with
cervical dystonia.
BOTOX® is approved for the treatment of strabismus and blepharospasm
associated with dystonia, including benign essential blepharospasm or VII nerve
disorders in patients 12 years of age and above.
The efficacy of BOTOX® treatment in deviations over 50 prism diopters,
in restrictive strabismus, in Duane's syndrome with lateral rectus weakness, and
in secondary strabismus caused by prior surgical over-recession of the antagonist
has not been established. BOTOX® is ineffective in chronic paralytic
strabismus except when used in conjunction with surgical repair to reduce antagonist
contracture.
And BOTOX® is approved for the treatment of severe primary axillary
hyperhidrosis that is inadequately managed with topical agents.
BOTOX® Cosmetic is approved for the temporary treatment of moderate
to severe frown lines between the brows in people ages 18 – 65.
Important Safety Information
Who should not be treated with BOTOX® and BOTOX®
Cosmetic
BOTOX® injections should not be given to people who have an infection
where the physician proposes to inject. They should not be given to people who are
known to be sensitive to any ingredient in the BOTOX® product.
Warnings
Serious heart problems and serious allergic reactions have been reported rarely.
If you think you're having an allergic reaction or other reaction, such as difficulty
swallowing, speaking, or breathing, call your doctor immediately.
Patients with certain neuromuscular disorders such as ALS, myasthenia gravis, or
Lambert-Eaton syndrome may be at increased risk of serious side effects.
Patients with neuromuscular disorders may be at increased risk of clinically significant
systemic effects including severe dysphagia (difficulty swallowing) and respiratory
compromise from typical doses of BOTOX® and BOTOX®
Cosmetic.
Dysphagia (difficulty swallowing) is a commonly reported adverse event following
treatment of cervical dystonia patients with all botulinum toxins. In these patients,
there are reports of rare cases of dysphagia severe enough to warrant the insertion
of a gastric feeding tube.
Precautions
Patients or caregivers should be advised to seek immediate medical attention if
swallowing, speech, or respiratory disorders arise.
Side Effects
Localized pain, infection, inflammation, tenderness, swelling, redness and/or bruising
may be associated with the injection.
In cervical dystonia, the most common side effects following injection include difficulty
swallowing (19%), upper respiratory infection (12%), neck pain (11%), and headache
(11%).
In blepharospasm, the most common side effects following injection include ptosis
(20.8%), inflammation of the cornea (6.3%), and eye dryness (6.3%).
In strabismus, the most common side effects following injection include ptosis (15.7%)
and vertical deviation (16.9%).
In severe primary axillary hyperhidrosis, the most common side effects (3-10% of
patients) include injection-site pain and bleeding, non-underarm sweating, infection,
sore throat, flu, headache, fever, neck or back pain, itching and anxiety.
The most common side effects following BOTOX® Cosmetic injections
include temporary eyelid droop and nausea.
Please see full product information at www.botox.com and www.botoxcosmetic.com.
Forward-Looking Statements
This press release contains "forward-looking statements," including the statements
by Dr. Whitcup, Dr. Fagien and other statements regarding the safety, effectiveness,
approval and market potential associated with LATISSE®, BOTOX®
and BOTOX® Cosmetic. These statements are based on current expectations
of future events. If underlying assumptions prove inaccurate or unknown risks or
uncertainties materialize, actual results could vary materially from Allergan's
expectations and projections. Risks and uncertainties include, among other things,
general industry, biologic and pharmaceutical market conditions; technological advances
and patents attained by competitors; challenges inherent in the research and development
and regulatory processes; inconsistency of treatment results among patients; potential
difficulties in manufacturing; general economic conditions; and governmental laws
and regulations affecting domestic and foreign operations. Allergan expressly disclaims
any intent or obligation to update these forward-looking statements except as required
by law. Additional information concerning these and other risk factors can be found
in press releases issued by Allergan, as well as Allergan's public periodic filings
with the Securities and Exchange Commission, including the discussion under the
heading "Risk Factors" in Allergan's 2007 Form 10-K and subsequently filed Forms
10-Q. Copies of Allergan's press releases and additional information about Allergan
are available on the World Wide Web at www.allergan.com or you can contact the
Allergan Investor Relations Department by calling 1-714-246-4636.
About Allergan, Inc.
Founded in 1950, Allergan, Inc., with headquarters in Irvine,
California, is a multi-specialty health care company that discovers, develops and
commercializes innovative pharmaceuticals, biologics and medical devices that enable
people to live life to its greatest potential — to see more clearly, move more freely,
express themselves more fully. The Company employs more than 8,500 people worldwide
and operates state-of-the-art R&D facilities and world-class manufacturing plants.
In addition to its discovery-to-development research organization, Allergan has
global marketing and sales capabilities with a presence in more than 100 countries.
Allergan Medical, a division of Allergan, Inc., offers the most comprehensive, science-based,
aesthetic product offerings under its Total Facial Rejuvenation™ portfolio,
including BOTOX® Cosmetic; hyaluronic acid and collagen-based dermal
fillers; and physician-dispensed skin care products. Allergan Medical also offers
the industry's widest range of silicone gel-filled and saline-filled breast implant
options for reconstructive and aesthetic breast surgery, and leading minimally invasive
devices for obesity intervention treatment.
Allergan Contacts
Caroline Van Hove (714) 227-5911 (media)
Heather Katt (714) 697-2981 (media)
Crystal Cienfuegos (714) 425-3454 (media)
Jim Hindman (714) 246-4636 (investors)
Joann Bradley (714) 246-4766 (investors)
Emil Schultz (714) 246-4474 (investors)
i Tosti et al., 2004
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