Simbrinza approved in EU for treatment of glaucoma
The European Commission has approved brinzolamide and brimonidine tartrate eye drops suspension for the treatment of elevated IOP in adults with open-angle glaucoma or ocular hypertension, according to a press release.
Brinzolamide 10 mg/mL and brimonidine tartrate 2 mg/mL (Simbrinza, Alcon/Novartis) is indicated for one drop into the affected eye(s) twice daily, allowing for a simpler schedule compared with separate doses of brinzolamide and brimonidine.
The agent is also the only fixed-combination glaucoma therapy without a beta-blocker, according to the press release.
In clinical studies, the suspension significantly lowered the IOP level from baseline by 23% while providing sustained IOP control throughout the day, according to the release.
The most common adverse events were ocular hyperemia and ocular allergic type reactions.
Complete study data will be presented at the 32nd Congress of the European Society of Cataract and Refractive Surgeons in London in September.
The fixed combination was approved by the U.S. Food and Drug Administration and has been available in the U.S. since 2013.