Simbrinza approved in EU to treat patients living with glaucoma

Tuesday, July 29, 2014

Basel (Switzerland): Alcon, a global leader in eye care and a division of Novartis, on Monday announced that Simbrinza eye drops suspension (brinzolamide 10mg/mL and brimonidine tartrate 2mg/mL) has been approved by the European Commission to decrease elevated intraocular pressure (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. 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, according to a statement by Novartis.

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, the statement said.

“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 Barbara Cvenkel, 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.”

The safety and efficacy of Simbrinza is based on two, pivotal six-month Phase III studies evaluating the safety and efficacy of Simbrinza administered twice daily, and enrolled a total of 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 through six months. Both studies met their primary endpoints, according to the statement.

In clinical studies, the most frequently reported adverse drug reactions in patients treated with Simbrinza were ocular hyperaemia and ocular allergic type reactions. The safety profile of brinzolamide 10 mg/mL and brimonidine tartrate 2 mg/mL eye drops suspension dosed twice daily (brinzolamide/brimonidine) was similar to that of the individual components and did not result in additional risk to patients relative to the known risks of the individual components, the statement said.

According to Novartis, 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 (FDA) and has been available in the market since 2013.

Largely underdiagnosed, glaucoma is the second cause of blindness after cataract and affects more than 60 million people worldwide. Glaucoma is a group of eye diseases that lead to progressive damage of the optic nerve and can result in gradual, irreversible loss of vision and eventually blindness. There is no cure for glaucoma and vision lost cannot be restored. Medications can lower eye pressure, the only known modifiable risk factor for glaucoma, but must be taken life-long and regularly. The exact cause of glaucoma is unknown.

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