FDA Approves IOP-Lowering Combination Drop

FDA Approves IOP-Lowering Combination Drop

The FDA recently approved Simbrinza, a fixed-dose combination of the carbonic anhydrase inhibitor brinzolamide (1.0%) and the alpha 2 adrenergic receptor agonist brimonidine tartrate (0.2%), for the reduction of elevated IOP in patients with open-angle glaucoma or ocular hypertension. We expect the new medication to be a valuable addition to our treatment arsenal, particularly for patients whose intraocular pressure is not well-controlled with a prostaglandin analog alone.

Simbrinza’s individual components have a long track record of efficacy, and having them together in one bottle should help to improve patient compliance by simplifying the treatment regimen. Also, Simbrinza is the only currently available combination formulation that doesn’t contain a beta blocker, which allows us to avoid the potential systemic side-effects associated with that drug class.

The FDA’s approval of Simbrinza was based on two 3-month clinical trials that compared its IOP-lowering effect with the effect of brinzolamide and brimonidine administered individually. Alcon, which developed the new medication, reported that the combination drop was superior to both components, reducing IOP by an additional 1-3 mmHg and achieving a mean IOP reduction of 21-35% by month 3. Adverse reactions and the rates at which they occurred in the trials were comparable to those of the individual components. The recommended dosing for Simbrinza is one drop in the affected eye three times per day.

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