New Formulation for LUMIGAN® Eyedrops Receives Positive Opinion in Europe

Important step towards approval of enhanced glaucoma medication LUMIGAN^® (bimatoprost ophthalmic solution) 0.01% in 27 countries within the European Union
Amsterdam, The Netherlands, 23 October, 2009 – Allergan Ltd. announced today that the Committee for Medicinal Products for Human Use (CHMP) has recommended granting a Marketing Authorisation for a new version of LUMIGAN^® (bimatoprost ophthalmic solution) 0.01% in the 27 member states of the European Union. LUMIGAN^® 0.01% is being evaluated as first-line therapy for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma and ocular hypertension.

“We are pleased with the decision reached by the Committee today to recommend LUMIGAN^® 0.01% for Marketing Authorization in Europe, which is an important step in the regulatory review process and one step closer to offering glaucoma patients an additional and enhanced treatment option.” said Mr. David Endicott, President, Allergan Ltd., Europe, Africa and the Middle East.  “The new LUMIGAN^® 0.01% formulation is expected to provide the same efficacy physicians have come to rely on with the original LUMIGAN^® formulation with enhanced tolerability, resulting in lower treatment-related discontinuation rates.”

LUMIGAN^® 0.01% is a once-daily prescription eye drop that delivers effective IOP-lowering results with just one-third of the active ingredient found in LUMIGAN^® 0.03%.  In a large, well-controlled clinical trial, 373 patients with chronic open-angle glaucoma or ocular hypertension were randomised receive either LUMIGAN^® 0.01% or 0.03% over a period of 12 months to assess efficacy and safety. This study showed LUMIGAN 0.01% controls IOP as effectively as LUMIGAN 0.03% but is better tolerated and associated with less conjunctival hyperaemia.  Overall, treatment related adverse events were significantly lower in patients treated with LUMIGAN^® 0.01% (p=0.016).

Significantly, there were 3 times less patients who discontinued treatment due to ocular adverse events in the LUMIGAN 0.01% group compared to the LUMIGAN 0.03% treatment group (p=0.043) .¹

The European Committee for Medicinal Products for Human Use (CHMP) is the scientific committee of the European Medicines Agency (EMEA) that makes recommends for Marketing Authorization across 27 member states of the European Union. The European Commission generally follows the CHMP recommendation and grants final Marketing Authorization within a few months following a positive recommendation. Pending the final approval by the European authorities, Allergan anticipates launching LUMIGAN^® 0.01% across the region in the fourth quarter of 2009.

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Notes to Editor

About Glaucoma

Glaucoma, a group of eye diseases characterized by damage to the optic nerve, is a leading cause of preventable blindness in the European Union².  It is estimated that more than 100,000 persons in the Netherlands suffer from glaucoma, with more than 70 million people affected across the world.3  A well established risk factor for glaucoma is elevated intraocular eye pressure (IOP), or pressure inside the eye.  A healthy eye produces fluids, called aqueous humor, at the same rate fluids are drained. If the aqueous humor is not removed rapidly enough or the eye fills too rapidly, pressure builds up in the eye, which can result in glaucoma.  This high pressure distorts the shape of the eye and damages the optic nerve.  Maintaining healthy IOP levels may slow the progression of the disease and help prevent loss of vision.

About Allergan

Founded in 1950, Allergan, Inc., with headquarters in Irvine, California, is a multi-specialty health care company that discovers, develops and commercializes innovative pharmaceuticals, biologics and medical devices that enable people to live life to its greatest potential – to see more clearly, move more freely, express themselves more fully. The Company employs more than 8,000 people worldwide and operates state-of-the-art R&D facilities and world-class manufacturing plants. In addition to its discovery-to-development research organization, Allergan has global marketing and sales capabilities with a presence in more than 100 countries.

Bron: ® and ™ Marks owned by Allergan, Inc.