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FDA Approves New Eye Drop Formulation

Washington, DC, September 7, 2010 - The FDA approved a new formulation of the drug bimatoprost (Lumigan) in a 0.01% solution as a first-line treatment to reduce elevated intraocular pressure in patients with open-angle glaucoma.

Approval was based on a three-month clinical trial of patients with open-angle glaucoma or ocular hypertension, with an average baseline intraocular pressure of 23.5 mm Hg.

The trial found intraocular pressure was reduced by up to 7 mm Hg with the 0.01% formulation with only one-third of the drug exposure compared with the 0.03% formulation of the same drug when the two were compared head-to-head.

The drug is taken once daily as an eye drop during the evening.

Side Effects and Risks

Bimatoprost may increase pigmentation of the iris, eyelid, and eyelashes. The drug may cause macular edema, especially in aphakic patients, pseudophakic patients with a torn posterior lens capsule, and patients at risk for macular edema. Adverse events associated with the drug include conjuctival hyperemia, eyelash growth, and ocular pruritus.

The drug Lumigan is manufactured by Allergan, Inc. based in Irvine, California.

Last reviewed on May 17, 2011

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