Allergan, Inc. (NYSE: AGN) today announced 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.
LATISSE(TM) Clinical Development Program
In the pivotal Phase III study, 278 healthy adult patients with no active ocular disease and with baseline minimal or moderate eyelash prominence were randomized to apply either LATISSE(TM) or vehicle to both upper eyelid margins once daily for 16 weeks. The primary efficacy endpoint was overall eyelash prominence at the end of the 16-week treatment period as measured by a a%JPY 1-grade improvement on a 4-point 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 LATISSE(TM) pivotal trial were met. By the end of the 16-week treatment period, patients treated with LATISSE(TM) experienced statistically significant greater improvement (p < 0.0001 for each endpoint) than those in the vehicle group in the measurements of eyelash prominence, length, thickness and darkness. LATISSE(TM) was also 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%).
LATISSE(TM) Safety Information
LATISSE(TM) solution is intended for use on the skin of the upper eyelid margins at the base of the eyelashes. DO NOT APPLY to the lower eyelid. If you are using LUMIGAN(R) or other products in the same class for elevated intraocular pressure (IOP), or if you have a history of abnormal IOP, you should only use LATISSE(TM) under the close supervision of your doctor.
LATISSE(TM) use may cause darkening of the eyelid skin which may be reversible. Although not reported in clinical studies, LATISSE(TM) 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 your skin that LATISSE(TM) 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 from 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 you stop using LATISSE(TM).
The most common side effects after using LATISSE(TM) solution are an itching sensation in the eyes and/or eye redness. This was reported in approximately 4% of patients. LATISSE(TM) solution may cause other less common side effects which typically occur on the skin close to where LATISSE(TM) is applied, or in the eyes. These include skin darkening, eye irritation, dryness of the eyes, and redness of the eyelids.
If you develop a new ocular condition (e.g., trauma or infection), experience a sudden decrease in visual acuity, have ocular surgery, or develop any ocular reactions, particularly conjunctivitis and eyelid reactions, you should immediately seek your doctor's advice concerning the continued use of LATISSE(TM) solution.
Full prescribing information is available at www.latisse.com and www.allergan.com.