Allergan, Inc. (NYSE:AGN) today announced the United States Food and Drug Administration (FDA) has approved LUMIGAN® (bimatoprost ophthalmic solution) 0.01% as a first-line therapy indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. LUMIGAN® 0.01% is an optimized reformulation of LUMIGAN® (bimatoprost ophthalmic solution) 0.03%.
“Based on its efficacy and tolerability, LUMIGAN® 0.01% should be considered early in the treatment continuum as an alternative to other prostaglandins or therapies.”
"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, M.D., Allergan's Executive Vice President, Research and Development, Chief Scientific Officer. "LUMIGAN® 0.01% exemplifies Allergan's commitment to developing medications for glaucoma patients that maximize efficacy while minimizing drug exposure."
LUMIGAN® 0.01% is a once-daily prescription eye drop that provides effective and sustained IOP lowering. In a three-month study of patients with open-angle glaucoma or ocular hypertension with an average baseline of 23.5 mm Hg, LUMIGAN® 0.01% lowered IOP up to 7 mm Hg from baseline, with only one-third the drug exposure of LUMIGAN® 0.03%.1 The most common side effects of LUMIGAN® 0.01% are hyperemia (red eyes), eyelash growth and ocular pruritis (itchy eyes).
"Once-a-day prostaglandins are becoming a therapy of choice based on their efficacy, systemic safety and ease of use," said L. Jay Katz, M.D., Director of the Glaucoma Service at Wills Eye Hospital and Professor of Ophthalmology at Jefferson Medical College. "Based on its efficacy and tolerability, LUMIGAN® 0.01% should be considered early in the treatment continuum as an alternative to other prostaglandins or therapies."
LUMIGAN® 0.01% will be available in the fourth quarter of 2010, and is the newest addition to Allergan's comprehensive glaucoma portfolio.