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New Formulation of Allergan's Alphagan P Receives U.S. FDA Approval
IRVINE, CA -- August 19, 2005 -- Allergan, Inc. today announced it has received approval from the U.S. Food and Drug Administration (FDA) to market AlphaganŽ P (brimonidine tartrate ophthalmic solution) 0.1%, indicated for the lowering of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.
The new product is an optimized formulation of Alphagan (brimonidine tartrate ophthalmic solution) 0.2%, and was developed to further minimize drug exposure while maintaining the drug's favorable efficacy profile. This FDA approval is the latest advance in the Alphagan Franchise, which includes Alphagan P 0.15%, and currently reflects the third-largest selling glaucoma franchise in the world(1).
"Our goal in developing Alphagan P 0.1% has been to ensure maximal efficacy of brimonidine with the least drug exposure possible," said Dr. Scott Whitcup, Allergan's Executive Vice President, Research & 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% was proven to have IOP-lowering efficacy equivalent to Alphagan 0.2%, effectively lowering IOP in patients with open-angle glaucoma or ocular hypertension by approximately 2-6 mmHg. Alphagan P 0.1% is contraindicated in patients receiving monoamine oxidase (MAO) inhibitor therapy. The most frequently reported adverse events included allergic conjunctivitis, conjunctival hyperemia and eye pruritus.
SOURCE: Allergan, Inc.
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