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FDA Approves Latisse
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The U.S. Food and Drug Administration (FDA) has approved Latisse (bimatoprost ophthalmic solution) 0.03% as a novel treatment for hypotrichosis of the eyelashes. Eyelash hypotrichosis is another name for having inadequate or not enough eyelashes.

Latisse is a once-daily prescription treatment applied to the base of the upper eyelashes with a sterile, single-use-per-eye disposable applicator. Latisse users can expect to experience longer, fuller and darker eyelashes in as little as eight weeks, with full results in 16 weeks. To maintain effect, continued treatment with Latisse is required. If use of Latisse is discontinued, eyelashes will gradually return to where they were prior to treatment over a period of weeks to months (average eyelash hair cycle).

Latisse was clinically tested in a pivotal Phase III, multi-center, double-masked, placebo-controlled study to assess its safety and efficacy in which all endpoints (improved eyelash prominence, length, thickness and darkness) were met. Bimatoprost, the active ingredient in Latisse, was first approved in 2001 as a medical product to lower intraocular pressure in people with open-angle glaucoma or ocular hypertension. Patients treated with bimatoprost for this specific eye condition experienced eyelash growth as a side effect. The long-term safety of bimatoprost for therapeutic use has been recognized by the medical community and well established based on use in 32 clinical trials involving more than 5,700 glaucoma patients and more than 13 years of clinical trial experience. Given the existing and substantial clinical and post-marketing safety data with bimatoprost solution 0.03%, coupled with the positive results from the Phase III Latisse study, Latisse provides patients a clinically meaningful aesthetic benefit with a favorable safety profile.

Bimatoprost is the active pharmaceutical ingredient in the formulation of Latisse and is a structural prostaglandin analog, a lipid compound derived from fatty acids designed to bind to prostaglandin (PG) receptors. PG receptors are present in hair, particularly in the dermal papilla and outer root sheath. Although the precise mechanism of action is unknown, PG receptors are thought to be involved in the development and regrowth of the hair follicle by increasing the percent of hairs in, and the duration of, the anagen or growth phase.

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