Alcon’s Simbrinza approved in EU for glaucoma

Alcon’s Simbrinza eye drops suspension has been approved by the EC to decrease elevated intraocular pressure (IOP) in adult patients with open-angle glaucoma or ocular hypertension, for which monotherapy provides insufficient IOP reduction.

Simbrinza is the only fixed-combination glaucoma treatment without a beta-blocker, which is contraindicated for many glaucoma patients suffering from certain respiratory or cardiac conditions.

Simbrinza (brinzolamide 10mg/mL and brimonidine tartrate 2mg/mL), administered with one drop into the affected eye(s) twice daily, combines two established treatments for elevated IOP into one multi-dose bottle, which is a simpler option compared to brinzolamide and brimonidine administered separately.

“Simbrinza complements Alcon’s glaucoma portfolio by addressing a significant unmet patient need. We are pleased to introduce the only fixed combination therapy without a beta-blocker to help more glaucoma patients manage their progressive eye condition,” said Jeff George, global head of Alcon. “As the leader in eye care, Alcon will continue to invest in R&D to expand our broad portfolio of glaucoma treatment options and to further reduce the burden of this silent, sight-threatening disease.”

Glaucoma is a group of chronic diseases with no cure and one of the leading causes of blindness worldwide. Open-angle glaucoma accounts for 74 per cent of all cases worldwide. This eye condition is asymptomatic, and less than 50 per cent of those with glaucoma are aware of their disease before blindness. Elevated IOP is the only known modifiable risk factor for glaucoma and can typically be controlled with daily administration of eye drops several times a day or, in the most severe cases, with surgery. In clinical studies Simbrinza showed strong efficacy to lower the IOP level from baseline by 23-37 per cent, while providing sustained IOP control throughout the day.

“Based on the literature, up to 80 per cent of patients deviate from their treatment regimen, resulting in poor adherence and the increased risk of progressive vision loss,” said Prof Barbara Cvenkel, head of Glaucoma Unit, Eye Hospital Ljubljana, Slovenia and member of the executive committee of the European Glaucoma Society.

Two pivotal six-month phase III studies evaluated the safety and efficacy of Simbrinza administered twice daily, enrolling 1,450 patients with open-angle glaucoma or ocular hypertension who were insufficiently controlled on monotherapy or were already using multiple IOP-lowering medications. The primary endpoint for both studies was an assessment of mean diurnal IOP change from baseline at three months, with safety and supportive efficacy evaluated over six months. Both studies met their primary endpoints.

The launch of Simbrinza in the EU will start in the UK in Q3 2014, followed by other European markets later in 2014 and 2015. It has been available in the US since 2013.

Alcon is the second largest division of the Novartis Group with sales of US$10.5 billion in 2013.

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