Swiss pharmaceutical giant Novartis AG (NVS) Monday announced that its eye care division Alcon's Simbrinza eye drops suspension has received approval by the European Commission.
The company said 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. In the US, Simbrinza was approved by the US Food and Drug Administration or FDA and has been available in the market since 2013.
Simbrinza (brinzolamide 10mg/mL and brimonidine tartrate 2mg/mL) has been approved by the EU to decrease elevated intraocular pressure or IOP in adult patients with open-angle glaucoma or ocular hypertension, for which monotherapy provides insufficient IOP reduction.
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, offering a simplified schedule compared to brinzolamide and brimonidine administered separately, the company said.
Simbrinza is also the only fixed-combination glaucoma treatment without a beta-blocker. Beta blockers are commonly prescribed to lower IOP, but are contraindicated for many glaucoma patients suffering from certain respiratory or cardiac conditions.
Glaucoma is a group of chronic diseases with no cure and one of the leading causes of blindness worldwide.
The company noted that the results of these two studies will be presented at the 32nd Congress of the European Society of Cataract and Refractive Surgeons (ESCRS) in London, UK, on September 13-17, 2014 and during the ESCRS Glaucoma Day Programme on September 12, 2014.
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