Allergan granted FDA approval for combination glaucoma medication
IRVINE, Calif. The U.S. Food and Drug Administration has approved Allergan's Combigan for reducing elevated IOP in patients with glaucoma or ocular hypertension, the company announced in a press release.
Combigan (0.2% brimonidine tartrate, 0.5% timolol maleate) is an alpha adrenergic receptor agonist with a beta adrenergic receptor inhibitor. The solution will be available to physicians as a prescription eye drop in the fourth quarter of this year, the release said.
In the 12-month pivotal trials, Combigan significantly reduced mean IOP up to 7.6 mm Hg from baseline and was well-tolerated by patients. Also, clinical studies found that Combigan provided an additional IOP-lowering effect over treatment with either brimonidine or timolol alone. Specifically, Combigan administered twice daily reduced IOP an additional 1 mm Hg to 3 mm Hg compared with brimonidine administered three times daily and an additional 1 mm Hg to 2 mm Hg compared with timolol administered twice daily.
However, the IOP-lowering effect of Combigan administered twice daily was slightly less than that seen with the concomitant use of 0.5% timolol administered twice daily and 0.2% brimonidine administered three times daily, according to the release.