<p>Maximum Medical Therapy: Brinzolamide/Brimonidine And Travoprost/Timolol Fixed-Dose Combinations In Glaucoma And Ocular Hypertension</p>

Abstract

IntroductionMaximal medical therapy (MMT) is the use of ≥3 classes of topical anti-glaucoma agents to achieve maximal intraocular pressure (IOP) reduction while minimizing adverse effects and compliance challenges.PurposeTo evaluate the additive IOP-lowering effect of twice-daily brinzolamide 1%/brimonidine 0.2% fixed-dose combination (BBFC) used adjunctively with once daily travoprost 0.004%/timolol 0.5% fixed-dose combination (TTFC) in patients with open-angle glaucoma (OAG)/ocular hypertension (OHT).MethodsIn this phase IV, double-masked study, patients on TTFC for ≥28 days, aged ≥18 years, with mean IOP ≥19 and ≤28 mmHg in at least 1 eye were randomized to receive BBFC+TTFC (n=67) or vehicle+TTFC (n=67) for 6 weeks. The primary endpoint was mean change in diurnal IOP from baseline (BL, averaged over 09:00 and 11:00) at Week 6.ResultsThe study was terminated prematurely due to recruitment challenges. BL mean IOP was similar in both groups (BBFC+TTFC: 21.6±1.78 mmHg; vehicle+TTFC: 21.8±1.90 mmHg). Mean change in diurnal IOP from BL at Week 6 was greater with BBFC+TTFC (−4.25 mmHg, 95% confidence interval [CI]: −4.7, −3.8) than with vehicle+TTFC (−2.11 mmHg, 95% CI: −2.6, −1.6, treatment difference, −2.15 mmHg (95% CI: −2.8, −1.5; P<0.001). Ocular adverse events (AEs) were reported in 11.9% of patients given BBFC+TTFC and 7.5% of patients given vehicle+TTFC. The AE with highest frequency was punctate keratitis (3%) in the BBFC+TTFC group; eye irritation (3%) in the vehicle+TTFC group.ConclusionBBFC+TTFC as MMT demonstrated clinically relevant and statistically significant reductions in mean diurnal IOP in patients with OAG/OHT. AEs were consistent with known safety profiles of individual medications.

Evaluation of the Use of Brinzolamide-Brimonidine Fixed Combination in Maximum Medical Therapy

“…Previous studies in the literature reported adverse drug reactions similar to those in our study after BBFC. 7 , 15 , 16 , 17 , 18 , 19 , 20 Similar to our study, Lerner et al 7 , reported that the rate of ocular adverse effects was 11.9% in patients who received maximum medical therapy in the form of BBFC and a beta-blocker/PG analog. In the same study, ocular adverse effects were observed in 7.5% of the control group given the beta-blocker/PG analog combination alone.…”

“…In a few recent studies, patients received a maximum medical therapy regimen of BBFC together with a beta-blocker/PG combination. Lerner et al 7 evaluated maximum medical therapy by investigating the additive efficacy of BBFC with travoprost/timolol fixed combination in 67 open-angle glaucoma and OHT patients and observed a statistically significant reduction in IOP in the group to which BBFC was added. Joh and Jin 18 divided patients who received maximum medical therapy into two groups, triple (dorzolamide-timolol combination + brimonidine + latanoprost) and double (tafluprost/timolol combination + BBFC) maximum therapy.…”

“…In maximum medical therapy, the use of three or more different classes of antiglaucoma agents is required to achieve a sufficient reduction in IOP. 7 In the treatment of glaucoma, two, three, or four-component glaucoma therapies can be applied separately, or they can be used as fixed combinations of two drugs in a single bottle to improve ease of use and reduce the adverse effects associated with preservatives. The use of fixed combinations is known to be more comfortable and more advantageous than the use of multiple drugs in terms of patient compliance, posology, ease of use, and adverse effects.…”

Efficacy and safety of a fixed combination of 1% brinzolamide and 0.1% brimonidine as treatment for glaucoma: a retrospective study focusing on the number of ingredients

“…Jin and Lee 15 reported that in a study involving cases of normal tension glaucoma treated with BBFC, the mean IOP decreased from 17.1±1.4 mm Hg to 12.4±1.8 mm Hg. In a study of the efficacy of a combination of travoprost/timolol with the addition of BBFC, Lerner et al 19 found a 4.25 mm Hg reduction of IOP after 6 weeks of treatment from baseline of 21.6 mm Hg, which was significantly better than that of the control group. Topouzis et al 20 added a combination of brinzolamide (1%)/brimonidine (0.2%) to PG and reported that the IOP reduced to 5.59 mm Hg from the baseline of 22.8 mm Hg after 6 weeks of treatment, as compared with that of the control group, showing a significant difference.…”

Frequent self-monitoring of intraocular pressure can determine effectiveness of medications in eyes with normal tension glaucoma: A case report

“…[ 12 ] The additional IOP lowering effect of BBFC on the existing therapy (0.004% travoprost/0.5 % timolol fixed-dose combination) was reported to be 2.15 mm Hg. [ 13 ] Because these IOP-lowering effects were measured by GAT and the baseline IOP was over 18 mm Hg, they cannot be directly compared to our NTG case. However, it is generally believed that even if the measurement device was the iCare HOME, the drug effects similar to those evaluated by the GAT could be obtained in individual cases by increasing the frequency of measurements.…”