Approximately 27 million women between the ages of 18 and 65 place importance on their eyelashes. This is an exciting opportunity to offer LATISSE® to women with inadequate or not enough eyelashes. LATISSE® is the first and only FDA-approved product indicated to treat hypotrichosis of the eyelashes by increasing their growth, including length, thickness, and darkness.
Not all consumers are potential LATISSE®patients. Only a physician can determine who is an appropriate patient.
Upon discontinuation of treatment, eyelash growth is expected to return to its pretreatment level. Patients should be informed of the possibility of disparity between eyes in length, thickness, pigmentation, number of eyelashes or vellus hairs, and/or direction of eyelash growth.
LATISSE® was studied in a multicenter, randomized, double-masked, vehicle-controlled, parallel-group study (N = 278). Patients applied LATISSE® nightly for 16 weeks:
The primary efficacy end point in the LATISSE® study was an increase in overall eyelash prominence as measured by at least a 1-grade increase on the Global Eyelash Assessment (GEA) scale* from baseline to the end of treatment period (week 16). In the clinical trial, 78% of LATISSE® patients experienced ≥ 1-grade increase vs 18% for vehicle and 33% experienced ≥ 2-grade increase vs 1% for vehicle at week 16.
Full dramatic effects in 16 weeks! Measurable improvements in length, fullness and darkness!
Important Safety Information
Warnings and Precautions: In patients using LUMIGAN® (bimatoprost ophthalmic solution) or other prostaglandin analogs for the treatment of elevated intraocular pressure (IOP), the concomitant use ofLATISSE® 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 bimatoprost solution was administered. 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.
There is the potential for hair growth to occur in areas where LATISSE® solution comes in repeated contact with skin surfaces. Apply LATISSE® only to the skin of the upper eyelid margin at the base of the eyelashes.
LATISSE® solution should be used with caution in patients with active intraocular inflammation (eg, uveitis) because the inflammation may be exacerbated.
LATISSE® contains benzalkonium chloride, which may be absorbed by soft contact lenses. Contact lenses should be removed prior to application of solution and may be reinserted 15 minutes following its administration.
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.
Postmarketing Experience: The following reactions have been identified during postmarketing use of LATISSE® in clinical practice: burning sensation (eyelid), erythema periorbital, eye swelling, eyelid irritation, eyelid edema, eyelid pruritus, iris hyperpigmentation, lacrimation increased, madarosis and trichorrhexis (temporary loss of a few eyelashes to loss of sections of eyelashes, and temporary eyelash breakage, respectively), rash (including macular, erythematous, and pruritic limited to the eyelids and periorbital region), skin discoloration (periorbital), and vision blurred.
Use in Specific Populations: Use in pediatric patients below the age of 16 years is not recommended because of potential safety concerns related to increased pigmentation following long-term chronic use.