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G. Manni, P. Denis, T. Zeyen, T. Aung, I. Filatori, J. James, C. Salem, T. Smoot; Comparison of Safety and Efficacy of Brinzolamide/Timolol (AZARGATM) vs. COSOPT® in Patients With Open-Angle Glaucoma or Ocular Hypertension. Invest. Ophthalmol. Vis. Sci. 2008;49(13):1211.
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To compare the intraocular pressure (IOP)-lowering efficacy of Brinzolamide 1%Timolol 0.5% ophthalmic Suspension (Brinz/Tim) and Dorzolamide 2%Timolol 0.5% ophthalmic Solution (COSOPT), each dosed twice-daily in patients with open-angle glaucoma or ocular hypertension in need of additional therapy
This was a 12-month multi-center, randomized, double-masked, active controlled parallel group study. Efficacy assessments included mean IOP and mean IOP change from baseline (after wash-out) at 8 AM & 10 AM at Week 2 & Months 3 & 9; and at 8 AM, 10 AM & 4 PM at Months 6 & 12. Primary efficacy was prospectively planned for the Month 6 IOP assessments at 8 AM, 10 AM & 4 PM. Month 9 & 12 were primarily for safety.
437 patients were enrolled; 220 were randomized to Brinz/Tim and 217 to COSOPT. Brinz/Tim produced IOP-lowering efficacy that is non-inferior to COSOPT with mean treatment-group differences numerically favoring Brinz/Tim at 9 of 12 assessment times. All upper 95% confidence limits were less than the protocol specified margin of +1.5 mmHg including the Month 6 primary efficacy time points. Brinz/Tim produced mean IOP reductions from baseline that were statistically significant at all measurement times, and ranged from 7 to 9 mmHg with up to 60% of patients achieving IOP levels <18 mmHg. While a similar overall safety profile was observed between the two treatment groups, Brinz/Tim showed an ocular comfort advantage over COSOPT in terms of adverse events for ocular irritation (2.7% vs 10.6%) and ocular pain (2.7% vs 6.5%).
Brinzolamide 1%/Timolol 0.5% Eye Drops, Suspension provides statistically significant and clinically relevant IOP-lowering efficacy that is non inferior to COSOPT. Additionally, Brinz//Tim provides an ocular comfort advantage over COSOPT.
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