Washington -- The FDA has approved the glaucoma drug bimatoprost for treatment of eyelash hypotrichosis -- lashes that are not long, thick or dark enough.
The drug, which will be marketed by Irvine, Calif.-based Allergan under the name Latisse for the new indication, is applied to the base of the upper eyelashes and increases growth within eight to 16 weeks, according to an Allergan press release.
The approval comes after a phase III, multicenter, double-blind, placebo-controlled trial of 278 patients with no baseline ocular disease in which all endpoints—eyelash prominence, length, thickness and darkness—were met. Common adverse events included redness of the eyes (3.6 percent of subjects), itchy eyes (3.6 percent) and skin hyperpigmentation (2.9 percent).
The drug is a structural prostaglandin analog, that is, a lipid compound derived from fatty acids that binds to prostaglandin (PG) receptors. These receptors are present in hair, particularly in the dermal papilla and outer root sheath.
Although the precise mechanism is unknown, PG receptors are thought to be involved in the development and regrowth of the hair follicle, according to Allergan.
Bimatoprost should not be applied to the lower eyelid, the company said, and patients using other products in the same class for elevated intraocular pressure should use bimatoprost under close physician supervision. If the drug is discontinued, eyelashes will return to normal length within the average eyelash hair cycle of a few weeks to a few months.
