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FDA approves new version of Allergan's Lumigan
Wednesday, September 01 2010 | Comments
What's This?
Allergan Inc. received approval from the Food and Drug Administration for Lumigan (bimatoprost) 0.01% ophthalmic solution 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%, which is intended to be used once daily, is an optimized reformulation of Lumigan 0.03% ophthalmic solution. Allergan said it could serve as a treatment option for patients who are either initiating treatment or switching medications.
In a three-month study that involved patients with open-angle glaucoma or ocular hypertension with an average baseline IOP of 23.5 mm Hg, Lumigan 0.01% lowered IOP up to 7 mm Hg from baseline, with only one third the drug exposure of Lumigan 0.03%, Allergan said.
The new product will be available starting in the fourth quarter.
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