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23 May 2014

Alcon Receives Positive CHMP Opinion for Simbrinza, a New Fixed-Dose Combination Medicine to Treat Patients with Glaucoma

Alcon, a global leader in eye care and division of Novartis, has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion for Simbrinza eye drops suspension (brinzolamide 10 mg/mL and brimonidine tartrate 2 mg/mL) to decrease elevated intraocular pressure (IOP) in adult patients with open-angle glaucoma or ocular hypertension, for whom monotherapy provides insufficient IOP reduction[1].


Simbrinza combines two medicines already approved for the treatment of elevated IOP into one multi-dose bottle, to be dosed with one drop into the affected eye(s) twice daily. If approved, this fixed-dose combination therapy will offer a simplified eye drop schedule and reduce the treatment burden for patients suffering from open-angle glaucoma or ocular hypertension.


"We are pleased by the positive CHMP opinion for Simbrinza. Glaucoma is a progressive eye disease that must be treated every day over the course of a patient's life. By combining two therapies in one, Simbrinza will help patients to effectively manage high eye pressure, with a simple dosing regimen", said Jeff George, Division Head, Alcon. "Alcon is committed to the research and development of medical and surgical solutions to treat this cause of irreversible blindness."



[1] Alcon data on file, 2013.

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