Novartis’ Alcon Gains EU Approval for Combination Eye-Care DrugBy
Alcon, the eye-car division of Novartis, reports that the European Commission has approved Simbrinza eye drops suspension (brinzolamide 10mg/mL and brimonidine tartrate 2mg/mL) to decrease elevated intraocular pressure (IOP) in adult patients with open-angle glaucoma or ocular hypertension, for which monotherapy provides insufficient IOP reduction.
The launch of Simbrinza in the EU will start in the UK in the third quarter of 2014, followed by other European markets later in 2014 and in 2015. Simbrinza was approved by the US Food and Drug Administration in 2013 and has been available in the US market since 2013.
Simbrinza, administered with one drop into the affected eye(s) twice daily, combines two well-established treatments for elevated IOP into one multi-dose bottle, to provide a simplified schedule compared to brinzolamide and brimonidine administered separately. Simbrinza is also the only fixed-combination glaucoma treatment without a beta-blocker, according to Novartis. Beta blockers are commonly prescribed to lower IOP, but are contraindicated for many glaucoma patients suffering from certain respiratory or cardiac conditions.