Allergan, Inc. (NYSE: AGN) announced that the U.S. Food and Drug Administration (FDA) has approved LATISSE(TM) (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(TM) is the first and only science-based treatment approved by the FDA to enhance eyelash prominence as measured by increases in length, thickness and darkness of eyelashes.
“LATISSE(TM) fulfills a significant and previously unmet need in the medical aesthetic marketplace with a product approved by the FDA that increases the growth of eyelashes, making them longer, thicker and darker,” said Scott Whitcup, M.D., Allergan’s Executive Vice President of Research and Development. “As the global leader in medical aesthetics, LATISSE(TM) exemplifies our continuing commitment to developing innovative treatments that are studied in well-controlled clinical trials, manufactured to pharmaceutical standards, appropriately labeled for use, and available to consumers as a prescription product.”
Available only through a doctor, LATISSE(TM) is a once-daily prescription treatment applied to the base of the upper eyelashes with a sterile, single-use-per-eye disposable applicator. LATISSE(TM) 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(TM) is required. If use of LATISSE(TM) is discontinued, eyelashes will gradually return to where they were prior to treatment over a period of weeks to months (average eyelash hair cycle).
Similar to Allergan’s other medical aesthetic offerings, the benefits of LATISSE(TM) are derived from scientific evidence, its quality formulation, and medical origin. LATISSE(TM) 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. In addition, like BOTOX(R) (botulinum toxin type A), which was first approved by the FDA as a medical treatment for eye disorders and was later found to have an aesthetic benefit, bimatoprost, the active ingredient in LATISSE(TM), 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(TM) study, LATISSE(TM) provides patients a clinically meaningful aesthetic benefit with a favorable safety profile.
Bimatoprost is the active pharmaceutical ingredient in the formulation of LATISSE(TM) 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,1 by increasing the percent of hairs in, and the duration of, the anagen or growth phase.
“As an oculoplastic surgeon who has treated both medical eye conditions as well as aesthetic needs, I have extensive knowledge of and experience with the established therapeutic safety profile for bimatoprost,” said Steven Fagien, M.D., F.A.C.S., in private practice at Aesthetic Eyelid Plastic Surgery in Boca Raton, Florida, and LATISSE(TM) clinical investigator. “In the clinical study with LATISSE(TM), I observed statistically significant differences in eyelash growth and resulting patient satisfaction. Now that LATISSE(TM) is FDA approved, I look forward to prescribing it to my patients who will enjoy the benefits of more prominent eyelashes while I remain confident in the treatment’s favorable safety profile.”
LATISSE(TM) will be available in the United States by prescription only and is subject to all U.S. guidelines applicable to dispensing a prescription product. Based on today’s FDA approval, Allergan expects to launch the product nationwide in the first quarter of 2009. Doctors and consumers are encouraged to visit www.latisse.com for further product and prescribing information.
Allergan estimates global peak sales of LATISSE(TM) could exceed $500 million per year. As the exclusive U.S. and foreign patent owner, Allergan obtains the rights to the use of bimatoprost and other prostaglandins and prostaglandin analogs as a treatment to stimulate eyelash growth.
Source: Allergan, USA