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September 1, 2010

FDA Clears Allergan’s Lumigan 0.01% Eye Drops for Lowering Intraocular Pressure

  • FDA has approved Allergan’s Lumigan® 0.01% bimatoprost solution as first-line therapy for reducing intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. The once-daily eye-drop product is an optimized reformulation of Lumigan 0.03%. Allergan says the drug will be available during the fourth quarter of 2010.

    A three-month study with Lumigan 0.01% showed that treatment lowered IOP up to 7 mmHg from baseline in patients with an average baseline of 23.5 mmHg, despite using only one-third of the drug concentration in Lumigan 0.03%.

    Allergan’s eyecare pharmaceuticals portfolio made net sales of $2.1 billion in the year to December 31 2010, up about $100,000 on sales in 2008. During May 2010 the firm reported FDA approval of Zymaxid™ 0.5%, a topical fluoroquinolone anti-infective indicated for the treatment of bacterial conjunctivitis. The firm projects to achieve Lumigan franchise product net sales of $490-$510 million  in 2010.

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