Bimatoprost 0.01% approved for reduction of IOP

Irvine, CA-Allergan Inc. announced the approval by the FDA of bimatoprost ophthalmic solution 0.01% (Lumigan) as a first-line therapy indicated for the reduction of elevated IOP in patients with open-angle glaucoma or ocular hypertension.

The solution is an optimized reformulation of bimatoprost 0.03% solution already on the market.

The once-daily prescription eye drop was tested over a 3-month period in patients with open-angle glaucoma or ocular hypertension with an average baseline of 23.5 mm Hg. The bimatoprost ophthalmic solution 0.01% lowered IOP up to 7 mm Hg from baseline.

Scott Whitcup, MD, Allergan’s executive vice president, research and development, and chief scientific officer, said, “[Bimatoprost ophthalmic solution 0.01%] exemplifies Allergan’s commitment to developing medications for glaucoma patients that maximize efficacy while minimizing drug exposure.”

Bimatoprost has been reported to cause changes in pigmented tissues, most frequently reported as the increased pigmentation of the iris, periorbital tissue, and eyelashes. Macular edema, including cystoid macular edema, has been reported during treatment with bimatoprost. Other common adverse reactions include conjunctival hyperemia, growth of eyelashes, and ocular pruritus.

According to Allergan, bimatoprost ophthalmic solution 0.01% will be available in the fourth quarter of 2010.