October 24, 2009
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European authorities recommend granting Lumigan marketing approval in Europe

MARLOW, UK — The Committee for Medicinal Products for Human Use (CHMP) has recommended granting Allergan marketing authorization for a 0.01% formulation of Lumigan in the European Union, the company announced.

The once-daily bimatoprost ophthalmic solution 0.01% formulation has been suggested as a first-line therapy for reducing IOP in patients with open-angle glaucoma and ocular hypertension, according to a press release form the company.

This follows positive results from a randomized clinical trial that found the 0.01% formulation to be as effective as the 0.03% formulation for reducing IOP among 373 patients with chronic open-angle glaucoma or ocular hypertension, the release said. During the 12-month study period, the 0.01% formulation demonstrated superior tolerability with less conjunctival hyperaemia, and statistically significantly less treatment-related adverse events.

"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," David Endicott, president of Allergan Ltd., Europe, Africa and the Middle East, said in the release.

Pending the final approval by the European Medicines Agency (EMA) , Allergan expects to initiate a European launch of the 0.01% formulation during the fourth quarter of 2009. Although the European Commission is not required to follow CHMP recommendations, it generally does.