Just before the New Year began, the FDA approved a new prescription product that significantly enhances eyelashes.

 

Developed by Irvine, Calif.-based Allergan, Inc. (NYSE: AGN), Latisse (bimatoprost ophthalmic solution) 0.03 percent is the first and only FDA-approved prescription treatment for eyelash hypotrichosis, which grows eyelashes longer, darker and thicker.

 

Earlier this year, Latisse was launched nationwide. Encouraged by the early response, Allergan estimates global peak sales could top $500 million per year.

 

"Latisse has benefited my patients because it works so well to lengthen and darken the eyelashes, complementing the results of Botox Cosmetic," said Mary Lupo, MD, a dermatologist from New Orleans. "Botox opens the eyes by relaxing muscles that pull the brows down. When you add Latisse, the eyes are further defined for a 'wow' effect."

Lupo began using Lumigan "off label" several months before Allergan rolled out Latisse and was astounded by the results. Within four weeks, her lashes were dramatically longer, fuller and darker, prompting her husband to ask, "Have your eyelashes always been this long?"

Latisse has been well-accepted as a prescription drug because it fulfills a significant and previously unmet need in the medical aesthetic marketplace, said Scott Whitcup, MD, Allergan's executive vice president of research and development.

 

A once-daily prescription treatment of Latisse applied to the base of the upper eyelashes with sterile, single-use-per-eye disposable applicators nets noticeable results in eight weeks, and significant improvement in 16 weeks. However, studies have shown that if use is discontinued, eyelashes will gradually return to pre-Latisse condition after the average eyelash growth cycle.

 

Steven Fagien, MD, an oculoplastic surgeon from Boca Raton, Fla., served as clinical investigator of Latisse, which was clinically tested in a Phase III, multi-center, double-masked, placebo-controlled study of 278 healthy adult patients with no active ocular disease and with baseline minimal or moderate eyelash prominence to assess its safety and efficacy. All endpoints (improved eyelash prominence, length, thickness and darkness) were met.

 

"In the clinical study with Latisse, I observed statistically significant differences in eyelash growth and resulting patient satisfaction," he said.

 

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 since the mid-1990s.

 

"Allergan is assessing the use of Latisse in other patient populations, including a planned study in patients who have undergone chemotherapy and lost their eyelashes," said Deborah Sherman, MD, an oculoplastic surgeon from Nashville, Tenn.

 

Bimatoprost 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, especially in the dermal papilla and outer root sheath. Even though 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 percentage of hairs in, and the duration of, the anagen or growth phase.

 

The most common side effects after using Latisse solution include an itching sensation in the eyes and/or eye redness, as reported in approximately 4 percent of patients. These may occur immediately after use, but usually last only a short period. Eye itching and eye redness are not allergic reactions, and do not mean that the patient's eyes are being harmed.

 

Latisse solution may cause other less common side effects, which typically occur on the skin close to where the drug is applied, or in the eyes. These include eye irritation, dryness of the eyes, and redness of the eyelids. The potential for increased brown iris pigmentation is noted in the Latisse label:
Patients should also be advised about the potential for increased brown iris pigmentation, which could be permanent.

 

"This was rarely seen when Lumigan (bimatoprost) was used as a topical eye drop (applied directly into the eye instead of topically like Latisse) in the clinical trials for its use for the treatment of glaucoma," said Fagien. "In the many thousands of patients that were effectively treated for glaucoma with the instillation of this drug directly onto the eye with approximately 20 times the effective dose that is used for eyelash enhancement, less than 2 percent of patients in these glaucoma studies had detectable changes in iris color. In the five-year study of this drug, this incidence dropped even further. When used appropriately as a topical application to the eyelid skin, the incidence of bimatoprost (Latisse) causing any detectable change in iris color should approach zero. In fact, during the FDA trials for the use of bimatoprost for the treatment of hypotrichosis (to enhance the appearance of the eyelashes making them longer, thicker, and darker), there were no reported cases of this problem."

 

Sherman, whose hazel eyes have reflected no color change since using Latisse, said the results are much better than she expected. "My lashes look as thick and long as they did in high school," she said, "two strokes of mascara and my eyelashes pop!"

 

Fagien said it's important for doctors to discuss with their patients the appropriate way to administer Latisse "to maximize the positive aesthetic effects while effectively minimizing any chance of them developing any problems related to treatment."

 

Even though a two-month supply of Latisse costs roughly $120 and is not covered by insurance, most patients have not voiced concern with the price.

 

"If they want longer lashes, they're willing to pay the price," said Lupo.

 

Sherman said many patients receive two months of therapy from one bottle of Latisse.

 

"Patients love that they have an alternative to a less expensive way to have their own natural lashes being bold and beautiful, compared to more expensive and time consuming procedures like lash extensions," she said.

 

Allergan developed Latisse in-house and markets it via consumer advertising with spokesperson Brooke Shields and directly to doctors through company representatives.