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LATISSE™ (bimatoprost ophthalmic solution)
0.03%— LATISSE™ solution was evaluated for its effect on overall eyelash prominence in a multicenter, double-masked, randomized, vehicle-controlled, parallel study including 278 adult patients for 4 months of treatment. The primary efficacy endpoint in this study was an increase in overall eyelash prominence as measured by at least a 1 -grade increase on the 4-point Global Eyelash Assessment (GEA) scale* from baseline to the end of the treatment period (week 16).2 — LATISSE™ increased eyelash prominence — Statistically significant differences vs vehicle seen at 8, 1 2, and 16 weeks2 — 78% of patients experienced an improvement in overall eyelash prominence by week 16 vs 18% for vehicle2 — LATISSE™ improved eyelash growth from baseline as measured by digital-image analysis assessing eyelash length, fullness/thickness, and darkness2 — Statistically significantly more pronounced in the bimatoprost group at weeks 8, 12, and 162
At week 162:
increase in growth
(length) 25%
vs 2% for vehicle vs 3% for vehicle — The most frequently reported adverse events were: — Eye pruritus, conjunctiva! hyperemia, skin hyperpigmentation, ocular irritation, dry eye symptoms, and erythema of the eyelid2 — These events occurred in less than 4% of patients2 LATISSE™ solution is applied once nightly directly to the skin of the upper eyelid margin at the base of the eyelashes using supplied, FDA-approved sterile applicators2 Important Safety Information Warnings and Precautions (continued): Increased iris pigmentation has occurred when the same formulation of bimatoprost ophthalmic solution (LUMIGAN®) was instilled directly onto the eye. Although iridal pigmentation was not reported in clinical studies with LATISSE™ patients should be advised about the potential for increased brown iris pigmentation which is likely to be permanent. Bimatoprost has been reported to cause pigment changes (darkening) to periorbital pigmented tissues and eyelashes. The pigmentation is expected to increase as long as bimatoprost is administered, but has been reported to be reversible upon discontinuation of bimatoprost in most patients. Adverse Reactions: The most frequently reported adverse events were eye pruritus, conjunctival hyperemia, skin hyperpigmentation, ocular irritation, dry eye symptoms, and erythema of the eyelid. These events occurred in less than 4% of patients. Note to representative: Please provide full prescribing information when presenting this material. •Patent pending. I . Data on file, Allergan, Inc., 2008; Study No. 1 95024-032. 2. LATISSE"" Prescribing Information. |
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