Simbrinza, from Novartis, approved by the FDA for glaucoma

April 22, 2013 | By Márcio Barra

The FDA approved last friday Simbrinza, from Novartis eye care division Alcon, for glaucoma treatment.

Simbrinza’s indication is for the reduction of elevated intraocular pressure in patients with primary open – angle galucome or ocular hypertension, where the optic nerve is damaged slowly and gradually until patients lose vision. Elevated intraocular pressure is the only modifiable risk factor for glaucoma, which affects more than 67 million people worldwide and is the second-leading cause of preventable blindness.

This drug is a combination of brinzolamide – a carbonic anhydrase inhibitor which inhibits the carbonic anhydrase in the ciliary processes of the eye, decreasing aqueous humor secretion and thus lowering the intraocular pressure – and brimonidine, an α2 adrenergic agonist which decreases the synthesis of aqueous humor. It’s the only fixed-dose combination therapy for glaucoma in the US without a beta blocker. Patients have to administer one drop of Simbrinza into the affected eye(s) three times per day.

In Phase III clinical studies, Simbrinza showed that this combination is more effective that either of the two agents taken alone, decreasing elevated IOP by 21- 35%.  By combining these two agents in a single bottle, it helps to reduce the medication burden for glaucoma patients. The most frequently reported adverse reactions, which affected approximately 3-5% of patients in descending order of incidence were blurred vision, eye irritation, dysgeusia (bad taste), dry mouth and eye allergy


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