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FDA approves bimatoprost 0.03% for treatment of hypotrichosis of eyelashes
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IRVINE, Calif. — The U.S. Food and Drug Administration has granted full approval to a 0.03% formulation of bimatoprost ophthalmic solution for the treatment of hypotrichosis of eyelashes, according to a press release from Allergan, the developer of the drug.
According to results from a multicenter, double-masked, placebo-controlled phase 3 clinical trial, when the once-daily treatment of Latisse (bimatoprost 0.03%) was applied to the base of the upper eyelashes, patients exhibited more prominent and thicker, longer and darker eyelashes. The trial also showed the safety of bimatoprost 0.03% in this application, according to the release.
Additional safety data on bimatoprost 0.03% for treatment of hypotrichosis of eyelashes was extracted from experience with its primary ingredient, bimatoprost, in the treatment of other ocular disorders. Bimatoprost was first approved in 2001 for lowering IOP in patients with open-angle glaucoma or ocular hypertension; some patients treated for glaucoma with bimatoprost experienced eyelash growth as a side effect.
Subsequently, the safety of bimatoprost was established in 32 clinical trials that enrolled more than 5,700 patients over 13 years, according to Allergan.
Allergan expects to launch bimatoprost 0.03% for treatment of hypotrichosis of eyelashes in the U.S. during the first quarter of 2009.