Allergan, Inc. announced that the US Food and Drug Administration has approved Combigan (brimonidine tartrate/timolol maleate ophthalmic solution) 0.2 per cent/0.5 per cent, an alpha adrenergic receptor agonist with a beta adrenergic receptor inhibitor, for the reduction of elevated intraocular pressure (IOP) in patients with glaucoma or ocular hypertension who require adjunctive or replacement therapy due to inadequately controlled IOP.
Combigan is the newest addition to Allergan's comprehensive glaucoma portfolio, which also includes Lumigan (bimatoprost ophthalmic solution) 0.03 per cent and Alphagan P (brimonidine tartrate ophthalmic solution) 0.1 per cent and 0.15 per cent.
"Combigan ophthalmic solution is a medication that provides well documented safety and efficacy for patients with inadequately controlled IOP," said Scott Whitcup, M.D., executive vice president, Research and Development, Allergan. "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 per cent dosed twice a day and brimonidine tartrate ophthalmic solution 0.2 per cent 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. The total number of glaucoma cases worldwide is estimated to be 65 million.
Combigan may potentiate syndromes associated with vascular insufficiency. While taking beta-blockers, patients may be more reactive to allergens. Beta-adrenergic blockade has been reported to potentiate muscle weakness consistent with certain myasthenic symptoms. Beta-adrenergic receptor blocking agents may mask hypoglycaemic symptoms in patients with diabetes mellitus. Beta-adrenergic blocking agents may mask certain clinical signs (e.g., tachycardia) of hyperthyroidism. Patients suspected of developing thyrotoxicosis should be managed carefully to avoid abrupt withdrawal of beta-adrenergic blocking agents that might precipitate a thyroid storm. Adverse reactions: The most common adverse reactions occurring in approximately 5 to 15 percent of patients included allergic conjunctivitis, conjunctival folliculosis, conjunctival hyperaemia, eye pruritus, and ocular burning and stinging.
With more than 55 years of experience providing high-quality, science-based products, Allergan, Inc., with headquarters in Irvine, California, discovers, develops and commercializes products in the ophthalmology, neurosciences, medical dermatology, medical aesthetics, obesity intervention, urologics and other specialty markets that deliver value to its customers, satisfy unmet medical needs, and improve patients' lives.