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Allergan granted FDA approval for combination glaucoma medication
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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.