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FDA approves 0.01% formulation of Lumigan
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IRVINE, Calif. — The U.S. Food and Drug Administration has approved the 0.01% formulation of Lumigan for reducing IOP in patients with open-angle glaucoma or ocular hypertension, according to a press release from Allergan, the manufacturer of the drug.
In a 3-month study among patients with open-angle glaucoma or ocular hypertension with an average baseline IOP of 23.5 mm Hg, the once-daily bimatoprost ophthalmic solution 0.01% formulation lowered IOP up to 7 mm Hg with one-third the drug exposure of the 0.03% formulation of the drug. Commonly reported side effects included hyperemia, eyelash growth and ocular pruritus, according to the release.
"The approval of Lumigan 0.01% provides doctors with an efficacious, safe and well-tolerated IOP-lowering medication for glaucoma patients who are either starting treatment or are changing their medication regimen," Scott Whitcup, MD, Allergan's executive vice president, research and development, and chief scientific officer, said in the release. "Lumigan 0.01% exemplifies Allergan's commitment to developing medications for glaucoma patients that maximize efficacy while minimizing drug exposure."
Allergan plans to officially launch the 0.01% formulation of Lumigan during the fourth quarter.