It’s official, as we reported a little over 2 weeks ago about pending approval of LATISSE(TM) to increase the length, number and darkness of a patient’s eyelashes Allergan made the announcement today that the FDA approved LATISSE(TM) (bimatoprost ophthalmic solution 0.03%), allowing it to be prescribed by doctors.
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).
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.
In studies LATISSE(TM) was 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%). 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.
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