Allergan receives OK to market new formulation to lower IOP

September 6, 2005

The FDA has granted approval to Allergan to market its brimonidine tartrate ophthalmic solution 0.1% (Alphagan P), indicated to lower IOP in patients with primary open-angle glaucoma (POAG) or ocular hypertension.

The FDA has granted approval to Allergan to market its brimonidine tartrate ophthalmic solution 0.1% (Alphagan P), indicated to lower IOP in patients with primary open-angle glaucoma (POAG) or ocular hypertension.

The new solution is an optimized formulation of brimonidine tartrate ophthalmic solution 0.2% (Alphagan) to minimize drug exposure further while maintaining the drug’s favorable efficacy profile, the company said. The product is the latest advance in the company’s glaucoma franchise, which also includes brimonidine tartrate ophthalmic solution 0.15% (Alphagan P), according to Allergan.

According to clinical trial results, the 0.1% ophthalmic solution was proven to have IOP-lowering efficacy equivalent to the 0.2% ophthalmic solution, effectively lowering IOP in patients with POAG or ocular hypertension by about 2 to 6 mm Hg.

The new approved solution is contraindicated in patients receiving monoamine oxidase inhibitor therapy, according to Allergan.