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Combigan receives ‘positive opinions’ from EU regulators
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IRVINE, Calif. — A combination drug for the treatment of glaucoma received positive opinions from European Union regulators, a step that will lead to the product’s availability across Europe, according to the drug’s developer, Allergan.
Combigan (0.2% brimonidine tartrate, 0.5% timolol maleate) is indicated for the reduction of IOP in patients with chronic open-angle glaucoma or ocular hypertension who are insufficiently responsive to topical beta-blockers, according to a press release from Allergan.
Allergan received the notice of the positive opinions from the Medicines and Healthcare products Regulatory Agency of the United Kingdom, which acted as the reference state in the mutual recognition process employed by the EU.
The company said it expects marketing authorization and national licenses for Combigan to be issued “in the coming months.”
Combigan received regulatory approval in Switzerland in December 2004, but it has not yet been approved in the United States or in the Asia-Pacific region.
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