Brimonidine/timolol receives FDA approval

Irvine, CA-Brimonidine tartrate 0.2%/timolol maleate 0.5% ophthalmic solution (Combigan, Allergan Inc.), an alpha adrenergic receptor agonist with a beta adrenergic receptor inhibitor, has been approved by the FDA for the reduction of elevated IOP in patients with glaucoma or ocular hypertension who require adjunctive or replacement therapy due to inadequately controlled IOP. The company expects the prescription eye drop to be available to physicians in the fourth quarter of this year.

“Many patients require more than one medication to meet their target IOP,” said E. Randy Craven, MD, director, Glaucoma and Cataract Consultants of Colorado, Littleton, and associate clinical professor of ophthalmology, University of Colorado School of Medicine, Denver. “With [brimonidine/timolol], it is exciting to be able to offer patients two strong agents in one bottle.”

In the 12-month pivotal trials in which Dr. Craven was involved, brimonidine/timolol significantly reduced mean IOP up to 7.6 mm Hg from baseline and was well-tolerated. Clinical studies found that the fixed-combination therapy provided additional IOP lowering versus either brimonidine or timolol used alone. The new drug, 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 the new drop 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.

The eye drop is contraindicated in patients with bronchial asthma, a history of bronchial asthma, or severe chronic obstructive pulmonary disease; in patients with sinus bradycardia, second- or third-degree atrioventricular block, overt cardiac failure, or cardiogenic shock; and in patients with hypersensitivity to any component of the product. The most common adverse reactions, occurring in approximately 5% to 15% of patients, included allergic conjunctivitis, conjunctival folliculosis, conjunctival hyperemia, eye pruritus, and ocular burning and stinging.