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New Lumigan Formulation Approved

Allergan, Inc. received approval from the FDA for Lumigan (bimatoprost ophthalmic solution) 0.01% as a first-line therapy for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.

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By: Tim Wright

Editor-in-Chief, Contract Pharma

Allergan, Inc. received approval from the FDA for Lumigan (bimatoprost ophthalmic solution) 0.01% as a first-line therapy for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. Lumigan 0.01% is an optimized reformulation of Lumigan 0.03%. The drug will be available in 4Q10.

A three-month study of patients with open-angle glaucoma or ocular hypertension with an average baseline of 23.5 mm Hg, showed Lumigan 0.01% lowered IOP as much as 7 mm Hg from baseline, with only one-third the drug exposure. The most common side effects are red eyes, eyelash growth and itchy eyes.

“The approval of Lumigan 0.01% provides doctors with an efficacious, safe and well-tolerated IOP-lowering medication for glaucoma patients who are either starting treatment or are changing their medication regimen,” said Scott Whitcup, M.D., Allergan’s executive vice president, R&D, chief scientific officer. “Lumigan 0.01% exemplifies Allergan’s commitment to developing medications for glaucoma patients that maximize efficacy while minimizing drug exposure.”

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