Allergen receives FDA approval for eyelash enhancement product

IRVINE, Calif. Pharmaceutical company Allergen has received Food and Drug Administration approval for a new prescription product that increases the length, thickness and darkness of eyelashes.

Latisse is a once-daily prescription treatment that is applied to the base of the upper eyelashes with a single-use-per-eye disposable applicator.

Users can expect to see longer, fuller and darker eyelashes in as little as eight weeks, with full results in 16 weeks. To maintain the effect, continued treatment with Latisse is required, according to the company. If a patient stops using the product, eyelashes will gradually return to where they were prior to treatment over a period of weeks to months.

The product will be available with a prescription only and is expected to launch nationwide in the first quarter of 2009. Allergen estimates global peak sales of Latisse could exceed $500 million a year.

Latisse was clinically tested in a Phase III, multi-center, double-masked, placebo-controlled study to assess its safety and efficacy. In addition, like Botox, 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.