Alcon announces FDA approval of Simbrinza therapy for glaucoma patients

April 29, 2013

 

Basel, Switzerland-Novartis International AG/Alcon has received FDA approval of Simbrinza suspension, a new beta blocker-free, fixed-dose combination therapy for glaucoma patients. Simbrinza suspension is indicated for reducing elevated IOP in patients with primary open-angle glaucoma or ocular hypertension.

The new ophthalmic suspension offers many treatment possibilities because of its strong efficacy and ability to decrease elevated IOP by 21%-35%, according to study results. Also, it is the only available, fixed-dose combination therapy for glaucoma in the US without a beta blocker.

Simbrinza suspension combines a carbonic anhydrase inhibitor (brinzolamide 1.0%) with an alpha 2 adrenergic receptor agonist (brimonidine Tartrate 0.2%) in one multi-dose bottle, helping to reduce the medication burden for glaucoma patients. Patients are to administer one drop of Simbrinza into the affected eye(s) TID.

FDA approval of Simbrinza is based on data from two pivotal Phase III clinical trials with approximately 1,300 patients. The studies evaluated the safety and efficacy of a fixed-dose combination of Brinzolamide 1.0% and Brimonidine 0.2%, administered TID, compared to separate TID dosing of one or the other component. Both studies met their primary endpoint and demonstrated that Simbrinza is statistically superior compared to either component regarding mean IOP at month 3 for all time points. In both studies, Simbrinza achieved a 5mm Hg to 9mm Hg reduction from baseline to month 3. Patients’ mean IOP at baseline was 22mm Hg to 36mm Hg.

In the two trials, the most frequently reported adverse reactions in patients treated with Simbrinza, occurring in approximately 3%-5% of patients in descending order of incidence, were blurred vision, eye irritation, bad taste, dry mouth, and eye allergy. Treatment discontinuation mainly due to adverse reaction was reported in 11% of Simbrinza patients. The safety profile of the combination agent (Simbrinza) is comparable to each of the individual components.

Additionally, there were no significant cardiovascular or pulmonary events found with Simbrinza in either clinical study conducted.