Allergan has announced that the FDA has approved Combigan 0.2%/0.5% for the reduction of elevated intraocular pressure in glaucoma or ocular hypertension patients, requiring adjunctive or replacement therapy due to inadequately controlled intraocular pressure.
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Combigan is a prescription eye drop that works in two ways to reduce elevated intraocular pressure (IOP) and will be available to physicians in the fourth quarter of 2007.
In the 12-month pivotal trials, Combigan significantly reduced mean IOP up to 7.6mm Hg from baseline and was well tolerated.
Scott Whitcup, executive vice president of R&D at Allergan, said: “Combigan ophthalmic solution is a medication that provides well-documented safety and efficacy for patients with inadequately controlled IOP. The development of Combigan, which has included five key clinical studies, underscores Allergan’s commitment to provide new treatment options for patients with glaucoma.”
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