Efficacy and tolerability of the fixed combination of brinzolamide 1% and timolol 0.5% in daily practice

Abstract

Introduction:The purpose of this study was to document the efficacy and tolerability of the new fixed-combination (FC) brinzolamide 1%/timolol 0.5% as used in daily practice throughout Germany.Methods:An open-label, multicenter, observational study of patients was performed that evaluated the transition from prior medication to brinzolamide/timolol FC for the reduction of intraocular pressure (IOP). Ophthalmologists measured IOP at baseline and 4–6 weeks after transition and assessed their satisfaction with brinzolamide/timolol FC. Patients assessed the tolerability of both their previous and new regimens, judged their satisfaction with brinzolamide/timolol, and reported their preference between their previous and new regimens. Patients transitioning from other FC products to brinzolamide/timolol FC were analyzed separately.Results:Data from 14,025 patients from 1161 centers were analyzed. Four to 6 weeks after transition to brinzolamide/timolol, patients experienced a mean IOP decrease of 3.9 ± 4.3 mm Hg (P < 0.0001). All of the predefined patient subgroups (grouped by previous therapy) demonstrated a significant mean IOP reduction following transition to brinzolamide/timolol (P < 0.0001). Patients judged brinzolamide/timolol tolerability more positively than they did their previous therapies (87.2% vs 53.7% favorable assessments) and reported a high satisfaction rating with brinzolamide/timolol (93.4%). Brinzolamide/timolol was preferred over previous therapy at a ratio of almost 9:1. Patients who transitioned from dorzolamide/timolol to brinzolamide/timolol (n = 2937) demonstrated a significant decrease in mean IOP (P < 0.0001), rated brinzolamide/timolol more tolerable than dorzolamide/timolol (88.9% vs 28.9%), and preferred brinzolamide/timolol at a ratio of more than 9:1. Patients who transitioned from brimonidine/timolol (n = 209) demonstrated a significant decrease in mean IOP (P < 0.0001), rated brinzolamide/timolol more tolerable (86.5% vs 32.1%), and preferred brinzolamide/timolol at a ratio of 11.5:1.Conclusions:The FC brinzolamide 1%/timolol 0.5% produced better IOP control than all previous therapies analyzed and demonstrated favorable tolerability and a high satisfaction rating, resulting in a strong patient preference for brinzolamide/timolol over previous therapies.

Safety and efficacy of a fixed versus unfixed brinzolamide/timolol combination in Japanese patients with open-angle glaucoma or ocular hypertension

“…The safety and efficacy of BRINZ/TIM-FC and BRINZ + TIM in this study were consistent with those reported in previous studies of these agents as combination therapy and monotherapy in other patient populations 10,11,18,19,21,22,30,31. Similar to the current study, which demonstrated comparable efficacy of BRINZ/TIM-FC and unfixed concomitant BRINZ + TIM, other clinical assessments of fixed-combination therapies have demonstrated that fixed-combination pharmacotherapies containing TIM and dorzolamide, a carbonic anhydrase inhibitor, or latanoprost, a prostaglandin analog, have efficacy similar to that of concomitant treatment with their active components 32–35.…”

Efficacy and safety of brinzolamide/timolol fixed combination compared with timolol in Japanese patients with open-angle glaucoma or ocular hypertension

“…One study of more than 10,000 German patients demonstrated the IOP-lowering efficacy of BRINZ/TIM-FC, with IOP reductions from baseline of nearly 4 mmHg; however, this was an open-label clinical trial in a study population that included previously untreated patients 38. A double-masked study compared the IOP-lowering efficacy of TIM monotherapy versus BRINZ/TIM-FC in patients from the United States who were previously untreated or who had undergone a sufficient washout of any prior ocular hypotensives before initiation of the study 23.…”

Phase III safety and efficacy study of long-term brinzolamide/timolol fixed combination in Japanese patients with open-angle glaucoma or ocular hypertension

“…BRINZ/TIM-FC has been shown to reduce IOP effectively in patients with open-angle glaucoma and ocular hypertension and to be noninferior to an alternative fixed-combination therapy comprising dorzolamide 2% and timolol 0.5% 16–18. In a double-masked, 52-week clinical trial comparing BRINZ/TIM-FC with a fixed combination of dorzolamide/timolol in patients with glaucoma or ocular hypertension, both fixed-combination agents decreased IOP and had safety profiles similar to those observed in the current study 17.…”

“…Brinzolamide 1%, a reversible carbonic anhydrase inhibitor, and timolol 0.5%, a β1/β2-blocker, effectively reduce IOP when used individually as topical monotherapy and exhibit increased efficacy when used in combination 16. A fixed combination of brinzolamide 1% and timolol 0.5% (BRINZ/TIM-FC) was demonstrated to be noninferior to a fixed-combination therapy of timolol plus an alternative carbonic anhydrase inhibitor, dorzolamide, and to be preferred over patients’ previous monotherapies and combined therapies 17,18…”