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EU Approves Alcon’s Simbrinza to Treat Patients with Glaucoma, Ocular Hypertension

Alcon, the global leader in eye care and a division of Novartis, has announced that their Simbrinza® eye drops have been approved by the European Co...

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|Jul 29|magazine7 min read

Alcon, the global leader in eye care and a division of Novartis, has announced that their Simbrinza® eye drops have been approved by the European Commission (EU) to decrease elevated intraocular pressure (IOP) in adult patients with open-angle glaucoma or ocular hypertension.

Simbrinza combines brinzolamide and brimonidine, two well-established treatments for elevated IOP, and is the only fixed-combination glaucoma treatment without a beta-blocker.

“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, in a news release.

“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 the second cause of blindness after cataract and affects more than 60 million people worldwide, according to the European Glaucoma Society. Less than 50 percent of those with glaucoma are even aware of their disease prior to 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. In severe cases, surgery is the only option.

“Based on the literature, up to 80 percent of patients deviate from their treatment regimen, resulting in poor adherence and the increased risk of progressive vision loss,” said Barbara Cvenkel, MD, Head of Glaucoma Unit, Eye Hospital Ljubljana, Slovenia and member of the Executive Committee of the European Glaucoma Society (EGS). “When appropriate, the EGS recommends the use of combination therapies, such as Simbrinza, which provides a less complicated administration routine by decreasing the number of eye drops to handle and reducing the treatment burden for patients affected by this eye disease.”

Two six-month studies were conducted by Alcon to evaluate the safety and efficacy of Simbrinza administered twice daily. A total of 1,450 patients with open-angle glaucoma or ocular hypertension were enrolled. Results of the studies are expected to be presented at the 32nd Congress of the European Society of Cataract and Refractive Surgeons in London, United Kingdom, on September 13-14, 2014, and during the Glaucoma Day Programme on September 12, 2014.

The launch of Simbrinza in the EU will begin in the UK in the third quarter of 2014, followed by other European markets in 2014 and 2015. In the US, Simbrinza was approved by the US Food and Drug Administration (FDA) and has been available in the market since 2013.