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Brimonidine Tartrate/Timolol Maleate Solution Approved for Glaucoma or Ocular Hypertension
“COMBIGAN ophthalmic solution is a medication that provides well documented safety and efficacy for patients with inadequately controlled IOP,” said Scott Whitcup, M.D., Allergan’s Executive Vice President, Research and Development. “The development of COMBIGAN™, which has included five key clinical studies, underscores Allergan’s commitment to provide new treatment options for patients with glaucoma.”
COMBIGAN is a prescription eye drop that works in two ways to reduce elevated IOP and will be available to physicians in the fourth quarter of 2007. Elevated IOP is a leading risk factor for glaucoma, and the only risk factor that can currently be treated.
“There is no cure for glaucoma; however, lowering elevated IOP can slow the progression of the disease and help prevent further vision loss,” said E. Randy Craven, M.D., Director of Glaucoma Consultants of Colorado and Associate Clinical Professor of Ophthalmology, University of Colorado School of Medicine. “Many patients require more than one medication to meet their target IOP. With COMBIGAN, it is exciting to be able to offer patients two strong agents in one bottle.”
In the 12-month pivotal trials, COMBIGAN significantly reduced mean IOP up to 7.6 mm Hg from baseline and was well tolerated. Clinical studies found that COMBIGAN ophthalmic solution provided an additional IOP lowering versus either brimonidine or timolol, the two agents included in the formulation of COMBIGAN, used alone. COMBIGAN administered twice a day provided an additional 1 to 3 mm Hg decrease in IOP over brimonidine treatment three times a day and an additional 1 to 2 mm Hg decrease over timolol treatment twice a day. The IOP-lowering of COMBIGAN ophthalmic solution dosed twice a day was slightly less than that seen with the concomitant administration of timolol maleate ophthalmic solution 0.5% dosed twice a day and brimonidine tartrate ophthalmic solution 0.2% dosed three times per day.
Glaucoma, a group of eye diseases characterized by damage to the optic nerve, is a leading cause of preventable blindness in the United States. It is estimated that more than three million Americans have glaucoma, but only half of those know they have it.4 The total number of glaucoma cases worldwide is estimated to be 65 million. One of the risk factors of glaucoma is elevated IOP, or pressure inside the eye. A healthy eye produces fluids, called aqueous humor, at the same rate fluids are drained. If the aqueous humor is not removed rapidly enough or too rapidly, pressure builds up in the eye, which can result in glaucoma. This high pressure distorts the shape and damages the optic nerve. Maintaining healthy IOP levels may slow the progression of the disease and help prevent loss of vision.