The U.S. Food and Drug Administration (FDA) has approved LATISSE(TM)(bimatoprost ophthalmic solution) 0.03% as a novel treatment forhypotrichosis of the eyelashes. Eyelash hypotrichosis is another name forhaving inadequate or not enough eyelashes. LATISSE(TM) is the first and onlyFDA-approved, science-based treatment to enhance eyelash prominence asmeasured by increases in length, thickness and darkness of eyelashes.
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Available only through a doctor, LATISSE(TM) is a once-daily prescriptiontreatment applied to the base of the upper eyelashes with a sterile,single-use-per-eye disposable applicator. LATISSE(TM) users can expect toexperience longer, fuller and darker eyelashes in as little as eight weeks,with full results in 16 weeks. To maintain effect, continued treatment withLATISSE(TM) is required. If use of LATISSE(TM) is discontinued, eyelasheswill gradually return to where they were prior to treatment over a period ofweeks to months (average eyelash hair cycle).
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LATISSE(TM) will be available in the United States by prescription onlyand is subject to all U.S. guidelines applicable to dispensing a prescriptionmedical product. Based on today's FDA approval, Allergan expects to launchthe product nationwide in the first quarter of 2009. Doctors and consumersare encouraged to visit www.latisse.com for further product and prescribinginformation.
IMPORTANT LATISSE(TM) SAFETY INFORMATION
LATISSE(TM) solution is intended for use on the skin of the upper eyelidmargins at the base of the eyelashes. DO NOT APPLY to the lower eyelid. Ifyou are using LUMIGAN(R) or other products in the same class for elevatedintraocular pressure (IOP), or if you have a history of abnormal IOP, youshould only use LATISSE(TM) under the close supervision of your doctor.
LATISSE(TM) use may cause darkening of the eyelid skin which may bereversible. Although not reported in clinical studies, LATISSE(TM) use mayalso cause increased brown pigmentation of the colored part of the eye whichis likely to be permanent.
It is possible for hair growth to occur in other areas of your skin thatLATISSE(TM) frequently touches. Any excess solution outside the upper eyelidmargin should be blotted with a tissue or other absorbent material to reducethe chance of this from happening. It is also possible for a difference ineyelash 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 anitching sensation in the eyes and/or eye redness. This was reported inapproximately 4% of patients. LATISSE(TM) solution may cause other lesscommon side effects which typically occur on the skin close to whereLATISSE(TM) is applied, or in the eyes. These include skin darkening, eyeirritation, 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, ordevelop any ocular reactions, particularly conjunctivitis and eyelidreactions, you should immediately seek your doctor's advice concerning thecontinued use of LATISSE(TM) solution.
Full prescribing information is available at www.latisse.com andwww.allergan.com.
NEWS: U.S Food and Drug Administration (FDA) Approves LATISSE(TM) --First and Only FDA Approved Treatment to Enhance Eyelash Prominence,including Length, Thickness and Darkness.
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SOURCE Allergan, Inc.