September 05, 2013
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Preservative-free Ganfort formulation gains marketing authorization for glaucoma in EU

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A preservative-free, single-dose formulation of Ganfort ophthalmic solution has been granted marketing authorization covering all 27 European Union countries by the European Medicines Agency, according to a news release.

Ganfort (bimatoprost 0.03% / timolol 0.5%, Allergan) is indicated for reduction of IOP in patients with open-angle glaucoma or ocular hypertension that is insufficiently responsive to topical beta-blockers or prostaglandin analogues.

The new unit dose formulation was shown in a 12-week study to be noninferior to the multi-dose formula while maintaining equivalent efficacy, the release said. Because it is in a single dose, preservatives are not needed, refrigeration is not required and patients are able to decide whether to use the medication in the morning or evening.

Ganfort unit dose should be available by mid-September, the release said.