EC approval for Allergan

California, USA-based Allergan says that it has received a license from the European Commission to market Ganfort, its Lumigan (bimatoprost ophthalmic solution) for the treatment of glaucoma, in the European Union.

\"We are extremely pleased with the European Commission\'s approval of Ganfort, which enables Allergan to provide physicians and patients throughout Europe with a once-daily, highly-effective and well-tolerated form of combination therapy for glaucoma,\" said Scott Whitcup, the firm\'s executive vice president, R&D.

Ganfort is indicated for the reduction of intraocular pressure in patients with open-angle glaucoma or ocular hypertension who are insufficiently responsive to topical beta blockers or prostaglandin analogs. A fixed combination of bimatoprost 0.03% and timolol maleate 0.5%, the product offers powerful IOP-lowering efficacy comparable to the free combination of these two agents, and greater efficacy than monotherapy with either agent used alone, says Allergan. It also provides clinically important IOP control in a once-daily dose, which is important for enhancing patient compliance - a key factor in controlling glaucoma, a leading cause of preventable blindness worldwide. In clinical trials, Ganfort also had a superior tolerability profile, including 40% less hyperemia compared to bimatoprost monotherapy, the company noted.