Common Frequently Asked Questions for Latisse
Q: How is LATISSE® solution different from other eyelash growth products?
A: Over-the-counter products condition eyelashes. Only LATISSE® has been approved by the FDA as a prescription treatment to grow eyelashes in people with inadequate or not enough eyelashes.
Q: What does FDA approved mean?
A: The US Food and Drug Administration (FDA) is the federal government agency charged with protecting the health and welfare of the US public by regulating prescription products. FDA regulations are extremely stringent, and when a drug is FDA approved, that means its efficacy and safety have been scientifically studied in valid clinical trials. FDA approval also requires the sponsoring pharmaceutical company to record all adverse events reported after the drug is approved.
LATISSE® received its FDA approval in December 2008.
Q. How can lashes change over time?
A: Initial data from a group of women diagnosed with eyelash hypotrichosis in the LATISSE® clinical studies suggest that eyelashes may change over time. These are the trends that were suggested:
• Length decreased with increasing age (based on an assessment of 607 women)
• Fullness decreased with increasing age (based on an assessment of 468 women)
• Darkness decreased with increasing age (based on an assessment of 568 women)
Q: What is hypotrichosis of the eyelashes?
A: Hypotrichosis is another name for having inadequate or not enough eyelashes.
Q. Does LATISSE® really work?
A: In a clinical study of 278 participants, 78% of LATISSE® users (107/137) experienced a significant increase in overall eyelash prominence (including elements of length, fullness, and darkness) at week 16, versus 18% for the vehicle (26/141).* Lashes were:
• 25% longer (2% for vehicle*)
• 106% fuller (12% for vehicle*)
• 18% darker (3% for vehicle*)
*Vehicle is the same solution as LATISSE® without the active ingredient.
Q: How does it work?
A: LATISSE® is believed to prolong the anagen (active growth) phase. The exact way it works is unknown.
Q: How do patients apply the product?
A: Patients should be informed that LATISSE® should be applied every night using only the accompanying sterile applicators. They should start by ensuring their face is clean, all makeup is removed, and their contact lenses are removed (if applicable). Then carefully place one drop of LATISSE® solution on the disposable sterile applicator and brush cautiously along the skin of the upper eyelid margin at the base of the eyelashes. If any LATISSE® solution gets into the eye, it is not expected to cause harm. The eye should not be rinsed. Patients should be informed not to apply to the lower eyelash line. Any excess solution outside the upper eyelid margin should be blotted with a tissue or other absorbent material.
Q: How should patients handle the bottle and applicators?
A: Patients should be instructed that the LATISSE® bottle must be maintained intact and to avoid allowing the tip of the bottle or applicator to contact surrounding structures, fingers, or any other unintended surface in order to avoid contamination of the bottle or applicator by common bacteria known to cause ocular infections. Patients should also be instructed to only use the applicator supplied with the product once and then discard it since reuse could result in using a contaminated applicator. Serious infections may result from using contaminated solutions or applicators.
Q: Who should not use LATISSE® solution?
A: Patients should not use LATISSE® solution if they are allergic to one of its ingredients.
Q: Whom should patients tell if they’re using LATISSE®?
A: Patients should tell their physician they are using LATISSE® especially if they have a history of eye pressure problems. They should also tell anyone conducting an eye pressure screening that they are using LATISSE® solution.
Q: Are there any special warnings associated with LATISSE® use?
A: LATISSE® solution is intended for use on the skin of the upper eyelid margin at the base of the eyelashes. DO NOT APPLY to the lower lid. If patients are using LUMIGAN® (bimatoprost ophthalmic solution) or other products in the same class used for elevated intraocular pressure (IOP), or if they have a history of abnormal IOP, they should only use LATISSE® under the close supervision of their physician.
LATISSE® use may cause darkening of the eyelid skin, which may be reversible. LATISSE® 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 the skin that LATISSE® 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 happening. It is also possible for a difference in eyelash length, thickness, fullness, pigmentation, number of eyelash hairs, and/or direction of eyelash growth to occur between eyes. These differences, should they occur, will usually go away if the patient stops using LATISSE® solution.A. 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.
Q: Is there potential for iris darkening?
A: 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.
Q. Is there potential for eyelid skin darkening?
A: Skin hyperpigmentation (or skin darkening) is a less common side effect that typically occurs close to where the solution is applied. The eyelid skin may look a little darker due to an increase of melanin in the skin. This is expected to reverse after several weeks to months if the patient stops using the product.
Q: What if patients stop using LATISSE®?
A: Patients’ lashes are expected to return to their previous appearance over several weeks to months.
Q: Why do contact lenses need to be removed before applying?
A: It’s recommended that patients remove their contact lenses because LATISSE® solution contains benzalkonium chloride (BAK), and this may be absorbed by soft contact lenses. Contacts may be reinserted 15 minutes following LATISSE® administration.
Q: Can patients continue to use mascara while using LATISSE®?
A: Yes, patients can use mascara in addition to LATISSE® solution.
Q: How soon can patients expect results?
A: It’s important for patients to remember that LATISSE® solution works gradually. While they may start seeing longer lashes after 4 weeks, they must use LATISSE® every day for 16 weeks for full results. They should not reduce or stop daily application of LATISSE® solution when they first notice results. After 16 weeks, they should talk to their doctor about ongoing use. Individual results may vary.
Q: Can patients use cotton swabs or other cosmetic brushes to apply LATISSE®?
A: No, LATISSE® should only be used with its FDA-approved sterile applicators, designed to help patients apply the product properly.
Q: What if LATISSE® gets in a patient’s eye?
A: It is not expected to cause harm. Patients don’t need to rinse their eye. Reinforce the proper application instructions.