Video: Allergan Announces U.S. Food and Drug Administration (FDA) Approval of Latisse(TM) -- First and Only Treatment Approved by the FDA for Hypotrichosis of...(ry efficacy endpoint was overall eyelash...)

Date:12/26/2008

ry 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
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SOURCE Allergan Copyright©2008 PR Newswire. All rights reserved

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