LATISSE® Gains FDA Approval as First Treatment for Hypotrichosis of Eyelashes

In December 2008, LATISSE® (bimatoprost ophthalmic solution) 0.03% from Allergan (Irvine, Calif.), was approved by the U.S. Food and Drug Administration as the first science-based treatment for hypotrichosis of the eyelashes.

LATISSE fulfills a significant and previously unmet need in the medical aesthetic marketplace. With once daily application, to the base of the upper eyelashes, the solution enhances eyelash prominence, as measured by increases in length, thickness and darkness.

The benefits of LATISSE are derived from scientific evidence, its quality formulation and medical origin. Bimatoprost, the active pharmaceutical ingredient in LATISSE, is a structural prostaglandin analog . A lipid compound derived from fatty acids designed to bind to prostaglandin (PG) receptors.

Prostaglandin 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.

Bimatoprost, synthesized in 1992, was first approved in 2001 as a medication to decrease elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. Initially in clinical studies and later in broad scale use for this indication, it became apparent that bimatoprost increased the growth of eyelashes.
Allergan embarked on a clinical development program with bimatoprost for eyelash growth based on this observation, along with a market need for safe and effective products to enhance eyelash prominence, and a large safety database . 32 clinical trials involving more than 5,700 glaucoma patients and more than 13 years of clinical trial experience. The intent of the LATISSE development program was to minimize drug exposure via topical application of a small dose of solution applied directly to the eyelid margin at the base of the eyelashes to achieve the desired efficacy and enhance the tolerability of what was already a well-characterized and acceptable safety profile.

LATISSE was clinically tested in a pivotal Phase III, multi-center, double-masked, placebo-controlled study to assess safety and efficacy. In this study, 278 healthy adult patients with no active ocular disease and with baseline minimal or moderate eyelash prominence were randomized to apply either the LATISSE solution or a placebo vehicle to both upper eyelid margins once daily for 16 weeks. The primary efficacy endpoint was an increase in overall eyelash prominence at the end of the 16 week treatment period as measured by a .1 grade improvement on a validated four point visual evaluation tool called a Global Eyelash Assessment Scale. Secondary efficacy endpoints were eyelash length, thickness and darkness as determined by digital image analysis of patient photographs taken in a standardized manner.

All of the endpoints in the pivotal trial were met. By the end of the 16 week period, patients treated with LATISSE solution experienced statistically greater improvement (p < 0.0001 for each endpoint) than those in the vehicle group based on the measurement of eyelash prominence, including increased length (25%), thickness (106%) and darkness (18%).Patient Satisfaction was enhanced in subjects treated with LATISSE as well. It was well tolerated with the most commonly reported adverse events being non-serious and cosmetic in nature.

Common adverse events observed in the clinical trial included eye redness (3.6%), itchy eyes (3.6%) and skin hyperpigmentation (2. 9%) but only eye redness was observed at a statistically higher amount than the vehicle group.

Many patients in the clinical study saw improvement as early as week eight with the full effect achieved in 16 weeks.

Nonetheless, it is important to let patients know that the onset of effect with the LATISSE solution is gradual. Application more than once a day is not recommended. Explaining the hair growth cycle to patients can be a useful way to set realistic expectations around the onset of action and to encourage compliance as daily use of LATISSE is necessary for continued effect on the hair cycle and optimal results. If use of the product is discontinued, eyelashes will gradually return to where they were prior to treatment over a period of several weeks to months.

Clinical trial patient, Cindy Ross, has experienced the benefit of continued use of LATISSE and has reported satisfaction with her results now that it is on the market. “Before using LATISSE my eyelashes were very short and I’ve always admired people with long, beautiful eyelashes. Now I can have them too,” she conveyed.When used under a physician’s supervision, LATISSE solution provides patients with a clinically meaningful aesthetic benefit and a favorable safety profile.



Important Safety Information

Contraindications: LATISSE is contraindicated in patients with hypersensitivity to bimatoprost or any other ingredient in this product.

Warnings and Precautions: In patients using LUMIGAN®, also from Allergan, or other prostaglandin analogs for the treatment of elevated IOP, 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.

There is the potential for hair growth to occur in areas where LATISSE solution comes in repeated contact with skin surfaces.

LATISSE solution should be used with caution in patients with active intraocular inflammation (e.g., uveitis) because the inflammation may be exacerbated.

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.

See full prescribing information at www.LATISSE.com