 | Increases overall eyelash prominence
LATISSE™ 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 | | | | |  | Statistically significant differences vs vehicle seen at 8, 12, and 16 weeks2 | | | | |  | 78% of patients experienced an improvement in overall eyelash prominence by week 16 vs 18% for vehicle2 | | | | |  | Most frequently reported adverse events were:
- Eye pruritus, conjunctival 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 Contraindications: LATISSE™ is contraindicated in patients with hypersensitivity to bimatoprost or any other ingredient in this product. Warnings and Precautions: Bimatoprost ophthalmic solution (LUMIGAN®)
lowers intraocular pressure (IOP) when instilled directly to the eye in
patients with elevated IOP. In clinical trials, in patients with or
without elevated IOP, LATISSE™ lowered IOP, however, the magnitude of
the reduction was not cause for clinical concern. In ocular
hypertension studies with LUMIGAN®, it has been shown that
exposure of the eye to more than one dose of bimatoprost daily may
decrease the intraocular pressure lowering effect. In patients using
LUMIGAN® or other prostaglandin analogs for the treatment of
elevated intraocular pressure, the concomitant use of LATISSE™ may
interfere with the desired reduction in IOP. Patients using
prostaglandin analogs including LUMIGAN® for IOP reduction
should only use LATISSE™ after consulting with their physician and
should be monitored for changes to their intraocular pressure.
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.
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