Allergan, Inc. has received approval from the US FDA to market Alphagan P (brimonidine tartrate ophthalmic solution) 0.1%, indicated for the lowering of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.
According to a company release, 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 favourable 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.
"Our goal in developing Alphagan P 0.1% has been to ensure maximal efficacy of brimonidine with the least drug exposure possible," Dr. Scott Whitcup, Allergan's executive vice president, Research & Development said adding, "By improving bioavailability compared to the original Alphagan 0.2%, we have managed to decrease drug concentration by half without sacrificing efficacy."
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.