FDA Approves Bimatoprost 0.01% Eye Drops for Glaucoma Patients

Washington, D.C. – The Food and Drug Administration (FDA) has recently approved bimatoprost 0.01% ophthalmic solution for the treatment of elevated intraocular pressure in individuals suffering from open-angle glaucoma or ocular hypertension. Bimatoprost 0.01% solution is sold under the brand name Lumigan and is manufactured by Allergan.

This new product presents patients with an alternative glaucoma treatment to Allergan’s 0.03% bimatoprost solution, which has been on the market for years. Both medications are administered once a day in the evening by applying one drop in each affected eye.

The FDA approved Lumigan 0.01% after a three-month study demonstrated that the drug lowered intraocular pressure by as much as 7.5 mm Hg from an average baseline of 23.5 mm Hg. This reduction is similar to the results achieved by the 0.03% solution, which has been shown to lower intraocular pressure by as much as 8 mm Hg.

The main upside of taking the new formulation is that patients can achieve almost identical results with only one third of the drug exposure. This reduction in drug exposure has resulted in greater tolerability of the treatment by patients as well as a decrease in adverse side effects such as:

  • Hyperemia
  • Eyelash growth
  • Ocular pruritus

An additional benefit of this new formulation is a significant drop in the discontinuation rate after one year of usage. Patients taking Lumigan 0.01% experienced an 8.1% discontinuation rate compared to 13.4% for patients taking Lumigan 0.03%.

Other adverse effects of bimatoprost solution include increased pigmentation in the iris, eyelid, and eyelashes. While the pigmentation changes experienced in the eyelid and eyelashes are generally reversible once treatment is discontinued, the pigmentation changes in the iris are often permanent. Hopefully, the new reduced-dosage formulation will reduce the risks of pigmentation changes as well.

Lumigan 0.01% should be available by prescription by the end of 2010.