In addition, like BOTOX® (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™, 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,1 by increasing the percent of hairs in, and the duration of, the anagen or growth phase.
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™ 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 =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™ pivotal trial were met. By the end of the 16-week treatment period, patients treated with LATISSE™ 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™ 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%).