This article is more than 5 years old. Information may no longer be current.
Alphagan P 0.1% receives U.S. marketing approval
Click Here to Manage Email Alerts
IRVINE, Calif. — U.S. regulators have granted marketing approval to an “optimized” formulation of the glaucoma drug Alphagan P, its maker stated in a press release.
Alphagan P (brimonidine tartrate, Allergan) 0.2% is already on the U.S. market, indicated for the lowering of IOP in patients with open-angle glaucoma or ocular hypertension. The new formulation of Alphagan P was “developed to further minimize drug exposure while maintaining the drug's favorable efficacy profile,” Allergan stated in the release.
"Our goal in developing Alphagan P 0.1% has been to ensure maximal efficacy of brimonidine with the least drug exposure possible," said Scott Whitcup, MD, Allergan's executive vice president for research and development. "By improving bioavailability compared to the original Alphagan 0.2%, we have managed to decrease drug concentration by half without sacrificing efficacy. This milestone underscores Allergan's commitment to providing eye care specialists and patients with safe and efficacious medicines."
In a clinical trial, Alphagan P ophthalmic solution 0.1% demonstrated IOP-lowering efficacy equivalent to Alphagan 0.2%, lowering IOP in patients with open-angle glaucoma or ocular hypertension by approximately 2 mm Hg to 6 mm Hg, Allergan stated in its release.
According to Allergan, the most frequently reported adverse events were allergic conjunctivitis, conjunctival hyperemia and eye pruritis. The company did not state when it expects to launch the new formulation.