New Prescription Product Increases Length, Thickness and Darkness
of Eyelashes IRVINE, Calif., Dec. 26 /PRNewswire-FirstCall/ --
Allergan, Inc. (NYSE: AGN) today announced the U.S. Food and Drug
Administration (FDA) has approved LATISSE(TM) (bimatoprost
ophthalmic solution) 0.03% as a novel treatment for hypotrichosis
of the eyelashes. Eyelash hypotrichosis is another name for having
inadequate or not enough eyelashes. LATISSE(TM) is the first and
only science-based treatment approved by the FDA to enhance eyelash
prominence as measured by increases in length, thickness and
darkness of eyelashes. To view the Multimedia News Release, go to:
http://www.prnewswire.com/mnr/latisse/36439/ "LATISSE(TM) fulfills
a significant and previously unmet need in the medical aesthetic
marketplace with a product approved by the FDA that increases the
growth of eyelashes, making them longer, thicker and darker," said
Scott Whitcup, M.D., Allergan's Executive Vice President of
Research and Development. "As the global leader in medical
aesthetics, LATISSE(TM) exemplifies our continuing commitment to
developing innovative treatments that are studied in
well-controlled clinical trials, manufactured to pharmaceutical
standards, appropriately labeled for use, and available to
consumers as a prescription product." Available only through a
doctor, LATISSE(TM) is a once-daily prescription treatment applied
to the base of the upper eyelashes with a sterile,
single-use-per-eye disposable applicator. LATISSE(TM) 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(TM) is required. If use of
LATISSE(TM) 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(TM) are derived from
scientific evidence, its quality formulation, and medical origin.
LATISSE(TM) 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(R) (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(TM), 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(TM) study,
LATISSE(TM) provides patients a clinically meaningful aesthetic
benefit with a favorable safety profile. Bimatoprost is the active
pharmaceutical ingredient in the formulation of LATISSE(TM) 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(TM) clinical investigator. "In the clinical
study with LATISSE(TM), I observed statistically significant
differences in eyelash growth and resulting patient satisfaction.
Now that LATISSE(TM) 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(TM) 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 http://www.latisse.com/ for further product and prescribing
information. Allergan estimates global peak sales of LATISSE(TM)
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(TM) 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(TM) 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 > or = 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(TM) pivotal trial were met. By the
end of the 16-week treatment period, patients treated with
LATISSE(TM) 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(TM) 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(TM) Safety Information
LATISSE(TM) 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(R) 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(TM) under
the close supervision of your doctor. LATISSE(TM) use may cause
darkening of the eyelid skin which may be reversible. Although not
reported in clinical studies, LATISSE(TM) 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(TM) 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(TM). The most common side effects after
using LATISSE(TM) solution are an itching sensation in the eyes
and/or eye redness. This was reported in approximately 4% of
patients. LATISSE(TM) solution may cause other less common side
effects which typically occur on the skin close to where
LATISSE(TM) 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(TM)
solution. Full prescribing information is available at
http://www.latisse.com/ and http://www.allergan.com/. Important
BOTOX(R) and BOTOX(R) Cosmetic (Botulinum Toxin Type A) Information
BOTOX(R) 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(R) 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(R) 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(R)
is ineffective in chronic paralytic strabismus except when used in
conjunction with surgical repair to reduce antagonist contracture.
And BOTOX(R) is approved for the treatment of severe primary
axillary hyperhidrosis that is inadequately managed with topical
agents. BOTOX(R) 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(R) and BOTOX(R) Cosmetic BOTOX(R) 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(R) 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(R) and BOTOX(R) 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(R) Cosmetic injections include temporary eyelid
droop and nausea. Please see full product information at
http://www.botox.com/ and http://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(TM), BOTOX(R) and BOTOX(R) 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 http://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(TM)
portfolio, including BOTOX(R) 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. (i) Tosti et
al., 2004 http://www.prnewswire.com/mnr/latisse/36439DATASOURCE:
Allergan CONTACT: Caroline Van Hove, +1-714-227-5911, Heather Katt,
+1-714-697-2981, Crystal Cienfuegos, +1-714-425-3454; or investors,
Jim Hindman, +1-714-246-4636, Joann Bradley, +1-714-246-4766, or
Emil Schultz, +1-714-246-4474, all of Allergan, Inc. Web Site:
http://www.allergan.com/ http://www.latisse.com/
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