Allergan Ltd announced 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 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 David Endicott, president, Allergan Ltd, Europe, Africa and the Middle East. “Clinical studies have shown that the new Lumigan 0.01% formulation provides 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 to 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 three 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.
Glaucoma, a group of eye diseases characterized by damage to the optic nerve, is a leading cause of preventable blindness in the European Union2.
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.