European Commission approves combination eye drops

August 7, 2014

The European Commission has approved the eye drop suspension of brinzolamide 10 mg/mL and brimonidine tartrate 2 mg/mL to decrease elevated intraocular pressure (IOP) in adult patients who have open-angle glaucoma or ocular hypertension.

The European Commission has approved the eye drop suspension of brinzolamide 10 mg/mL and brimonidine tartrate 2 mg/mL (Simbrinza, Alcon) to decrease elevated intraocular pressure (IOP) in adult patients who have open-angle glaucoma or ocular hypertension and for whom monotherapy has provided insufficient IOP reduction.

By combining two well-established treatments for elevated IOP into one multi-dose bottle, Simbrinza offers a simplified schedule for patients compared to brinzolamide and brimonidine administered separately.

In clinical studies, Simbrinza lowered IOP by 23% to 37% from baseline and provided sustained IOP control throughout the day. In addition, the safety profile of brinzolamide 10 mg/mL and brimonidine tartrate 2 mg/mL eye drops suspension dosed twice daily 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.

"Based on the literature, up to 80% of [glaucoma or ocular hypertension] patients deviate from their treatment regimen, resulting in poor adherence and the increased risk of progressive vision loss", said Dr 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, 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 launch of Simbrinza in the EU is expected to start in the UK in the third quarter of 2014, followed by other European markets later in 2014 and in 2015.