09/01/2010 0 Comments

Allergan has received approval from the U.S. Food and Drug Administration for Lumigan 0.01% as a first-line therapy indicated for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension.

Lumigan 0.01% is an optimized reformulation of Lumigan 0.03%. In a three-month study of patients with open-angle glaucoma or ocular hypertension with an average baseline of 23.5 mmHg, Lumigan 0.01% lowered IOP up to 7 mmHg from baseline. The new formula achieved these results with only one-third the drug exposure of Lumigan 0.03%, the company reported in a press 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,” said Scott Whitcup, executive vice president of R&D and chief scientific officer at Allergan. “Lumigan 0.01% exemplifies Allergan's commitment to developing medications for glaucoma patients that maximize efficacy while minimizing drug exposure."

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