Prophylactic effect of brinzolamide-brimonidine fixed combination on intraocular pressure spikes after intravitreal anti-VEGF injections.

PURPOSE: To evaluate the effect of topical prophylaxis with brinzolamide-brimonidine fixed combination on short-term intraocular pressure (IOP) elevation after intravitreal injections of anti-vascular endothelial growth factors (anti-VEGF). METHODS: This prospective comparative study included 56 eyes of 47 patients treated with intravitreal injections of anti-VEGF, and they were randomly divided into two groups. In control group (25 eyes), no prophylactic medication was used, whereas in case group (31 eyes) one drop of a fixed combination of brinzolamide-brimonidine was instilled two hours before the injection. IOP was measured before the injection and at 1 min, 10 min and 30 min post-injection in all eyes. RESULTS: The mean IOP before injection at 1 min, 10 min and 30 min post-injection was 16,6 ± 2,8 mmHg, 53,4 ± 12 mmHg, 26,4 ± 5,5 mmHg and 17,9 ± 4 mmHg, respectively, in control group and 15,1 ± 3,4 mmHg, 42,6 ± 8,4 mmHg, 21,4 ± 5,5 mmHg and 12,4 ± 3,5 mmHg, respectively, in case group. At 1 min, 10 min and 30 min post-injection, the mean IOP was significantly lower in case group compared with control group (p < 0,001, p = 0,0014 and p < 0,0001, respectively), but no difference at the pre-injection IOP between the two groups was found (p = 0,09). CONCLUSIONS: The prophylactic administration of one drop of brinzolamide-brimonidine fixed combination significantly reduces the IOP spikes during the first 30 min after the intravitreal anti-VEGF injection.

Real-life experience of using brinzolamide/brimonidine fixed drop combination in a tertiary glaucoma centre.

PURPOSE: To investigate the intraocular pressure (IOP)-lowering efficacy and tolerance of brinzolamide/brimonidine fixed combination (BBFC) under real-life conditions in a tertiary glaucoma centre. METHODS: Medical records of all ocular hypertensive and open-angle glaucoma patients (n = 52) treated with BBFC were retrospectively analysed. RESULTS: Thirty-nine patients had primary open-angle, 6 exfoliative, 2 pigment, 1 normal tension and 1 juvenile open-angle glaucoma and 3 ocular hypertension. The prior therapy was a prostaglandin analogue (PG) (n = 4), PG/timolol (n = 20), PG/timolol and topical carbonic anhydrase inhibitor (CAI; n = 19), timolol/CAI (n = 1), PG and CAI (n = 4), timolol/pilocarpine and PG (n = 1), timolol/brimonidine and PG (n = 1) and timolol/brimonidine, PG and CAI (n = 2). These were simplified to PG/timolol and BBFC (n = 41), PG and BBFC (n = 9), timolol and BBFC (n = 1) and timolol/pilocarpine, PG and BBFC (n = 1). The IOP on the study eyes was 21.2 ± 3.7 mmHg before and 16.9 ± 2.6, 16.0 ± 2.2, 17.6 ± 3.1 and 18.0 ± 3.1 mmHg after the introduction of BBFC at month 1, 3, 6 and 12, respectively (p < 0.0003 for all time points compared to baseline, p = 1.0 for all other comparisons). Thirty-one patients (59.6%) experienced no adverse event, 17 (32.7%) reported ocular and 6 (11.5%) systemic adverse events. BBFC therapy was terminated on 27 patients (51.9%): on 19 (36.5%) due to adverse events and on 8 (15.4%) due to insufficient IOP reduction. CONCLUSION: In real-life practice, the introduction of BBCF allows significant and clinically meaningful IOP reduction and therapy simplification in glaucoma patients requiring complex medication, but in more than one third of the patients it is not tolerated due to adverse events.

A Comparative Study on Efficacy of Intraocular Pressure Lowering of Two Fixed-Dose Antiglaucoma Drug Combination Brinzolamide-Brimonidine Versus Latanoprost-Timolol in Primary Open-Angle Glaucoma and Ocular Hypertension.

Purpose: To compare the efficacy of Brinzolamide-Brimonidine (BB) (1%+0.2%) with the gold standard Latanoprost-Timolol (LT) (0.005%+0.5%) in treating primary open-angle glaucoma (POAG) and ocular hypertension (OHT). Methods: A 1-year prospective study, spanning from May 2022 to May 2023, conducted at a tertiary eye-care hospital. Participants, aged 40-60, with a baseline intraocular pressure (IOP) >21 mm Hg, requiring a >30% reduction, were enrolled. Group A (n = 100) received BB, and Group B (n = 100) received LT. Outcomes were assessed at 1 month (IOP difference from baseline), 3 and 6 months (mean diurnal variations). Results: The mean age at presentation was 55.5 ± 4.5 years in Group A and 54.7 ± 4.2 years in Group B. At 1 month, Group A exhibited a mean IOP of 18.7 mm Hg, while Group B had 17.6 mm Hg, with no statistically significant difference (P = 0.53). No significant diurnal variation was observed in either group (P = 0.07). Target pressure was achieved in 88% of patients in Group A and slightly higher at 92% in Group B. Moreover, no serious side effects were reported, and compliance was higher in Group B (98%) compared to Group A (96%). Conclusion: Although LT showed slightly better and sustained IOP reduction, the difference was not statistically significant. Both BB and LT demonstrated comparable outcomes for managing POAG and OHT.

Brinzolamide/brimonidine fixed-dose combination bid as an adjunct to a prostaglandin analog for open-angle glaucoma/ocular hypertension.

PURPOSE: To evaluate the additive intraocular pressure-lowering effect of twice-daily brinzolamide 1%/brimonidine 0.2% fixed-dose combination (BBFC) as an adjunct to a prostaglandin analog (PGA) in patients with open-angle glaucoma or ocular hypertension insufficiently controlled with PGA monotherapy. METHODS: In this Phase 4, double-masked trial, patients aged ⩾18 years, with a mean intraocular pressure of ⩾19 and <32 mm Hg in at least one eye were randomized (1:1) to receive BBFC + PGA (n = 96) or vehicle + PGA (n = 92) for 6 weeks. The primary endpoint was the mean change in diurnal intraocular pressure from baseline (averaged over 09:00 and 11:00 h) at Week 6. RESULTS: The mean diurnal intraocular pressure at baseline was similar in the BBFC + PGA (22.8 mm Hg) and vehicle + PGA (22.9 mm Hg) groups. The least squares mean change in diurnal intraocular pressure from baseline at Week 6 was greater with BBFC + PGA (-5.59 mm Hg (95% confidence interval: -6.2 to -5.0)) than with vehicle + PGA (-2.15 mm Hg (95% confidence interval: -2.7 to -1.6)); the treatment difference was statistically significant in favor of BBFC + PGA (-3.44 mm Hg, (95% confidence interval: -4.2 to -2.7); p < 0.001). Ocular adverse events were reported in 21.1% and 8.7% of patients in the BBFC + PGA and vehicle + PGA groups, respectively. The most frequent ocular adverse event was ocular hyperemia (5.3%) in the BBFC + PGA group and blurred vision (2.2%) in the vehicle + PGA group. CONCLUSION: BBFC + PGA significantly reduced mean diurnal intraocular pressure than PGA alone in patients with open-angle glaucoma or ocular hypertension. The safety findings with BBFC + PGA were consistent with the known safety profile of the individual medications.

Brinzolamide-brimonidine fixed combination for the prevention of intraocular pressure elevation after phacoemulsification.

AIM: To evaluate the effectiveness of brinzolamide-brimonidine fixed combination to control the intraocular pressure elevation throughout the first 24 h following uncomplicated phacoemulsification cataract surgery. PATIENTS AND METHODS: A total of 62 patients who underwent phacoemulsification cataract surgery were included in this prospective randomized comparative case series. The brinzolamide-brimonidine fixed combination group (34 eyes) was administered a single dose of brinzolamide-brimonidine fixed combination immediately after phacoemulsification. No treatment was administered in the control group (28 eyes). Intraocular pressure was measured 1 day before surgery (baseline) and at 6, 12 and 24 h postoperatively. RESULTS: The brinzolamide-brimonidine fixed combination group had significantly lower intraocular pressure at 6, 12 and 24 h after phacoemulsification compared to baseline (p < 0.0001 for all comparisons), while in control group, intraocular pressure was significantly higher at 6 and 12 h after surgery compared to baseline (p < 0.001 and p < 0.0001, respectively). In control group, an intraocular pressure elevation ⩾ 5 mm Hg was noted in 32.4% of the eyes at 6 and 12 h and in 5.9% of eyes at 24 h after surgery, while in brinzolamide-brimonidine fixed combination group, only 8.8% of the eyes at 6 h postoperatively had such an intraocular pressure elevation. CONCLUSION: The administration of a single drop of brinzolamide-brimonidine fixed combination effectively prevented intraocular pressure elevations and intraocular pressure spikes during the first 24 h after uneventful phacoemulsification.

Comparison of the Intraocular Pressure-Lowering Efficacy and Safety of the Brinzolamide/Brimonidine Fixed-Dose Combination versus Concomitant Use of Brinzolamide and Brimonidine for Management of Open-Angle Glaucoma or Ocular Hypertension.

OBJECTIVE: To demonstrate that the intraocular pressure (IOP)-lowering efficacy of a twice-daily brinzolamide 10 mg/mL (BRINZ)/brimonidine 2 mg/mL (BRIM) fixed-dose combination (BBFC) was non-inferior to its individual components (BRINZ+BRIM) dosed concomitantly in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT). Safety was also evaluated. METHODS AND ANALYSIS: This was a Phase III, multicenter, observer-masked study in patients from China, Russia and Taiwan. Patients aged ≥18 years with a mean IOP ≥21 mmHg and ≤36 mmHg in the same eye after washout of other IOP-lowering medications were included. Eligible patients were randomized (1:1) to receive BBFC or BRIZ+BRIM eye drops twice daily for 3 months. The primary endpoint was the mean change in diurnal IOP (averaged over 09:00, +2 h, and +7 h) from baseline to Month 3. Adverse events (AEs) were recorded throughout the study. RESULTS: The per-protocol set included 349 patients (BBFC, n=172; BRINZ+BRIM, n=177). The mean±standard deviation diurnal IOP at baseline was 24.6±2.66 mmHg in both groups. At Month 3, the least square mean±standard error change in diurnal IOP from baseline was -7.2±0.34 mmHg and -7.3±0.34 mmHg with BBFC and BRINZ+BRIM, respectively (between-group difference: 0.1 mmHg [95% CI -0.5, 0.7]). In the BBFC and BRINZ+BRIM groups, 53.3% and 55.0% of patients achieved a diurnal IOP <18 mmHg, and 43.2% and 37.4% of patients, respectively, achieved a mean diurnal IOP reduction >30% from baseline at Month 3. Ocular AEs were reported in 28.7% (BBFC) and 22.5% (BRINZ+BRIM) of patients; conjunctival hyperemia was the most frequent ocular AE (BBFC, 6.4%; BRINZ+BRIM, 6.8%). Non-ocular AEs were reported in 32.4% (BBFC) and 30.4% (BRINZ+BRIM) of patients. CONCLUSION: The study findings demonstrate that the efficacy of twice-daily BBFC was non-inferior to BRINZ+BRIM in patients with OAG/OHT. The safety profile of BBFC was similar to that of BRINZ+BRIM.

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

INTRODUCTION: Maximal 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. PURPOSE: To 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). METHODS: In 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. RESULTS: The 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. CONCLUSION: BBFC+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.

Brinzolamide/Brimonidine Fixed Combination: Simplifying Glaucoma Treatment Regimens.

INTRODUCTION: To simplify the medical treatment of glaucoma for patients on multiple drops by introducing brinzolamide/brimonidine tartrate fixed combination (BBFC) ophthalmic suspension 1%/0.2% (SIMBRINZA®; Alcon Laboratories, Inc., Fort Worth, TX, USA) to the drop regimen and to establish its efficacy. To demonstrate that fixed combination (FC) therapies are associated with improvements in treatment adherence and persistence with reduced exposure to preservative-related ocular surface problems. METHODS: Retrospective study: 76 patients were identified as taking BBFC following a switch in treatment regimen. Intraocular pressure (IOP) prior to and 2-17.5 months (average 5.4 months) after the introduction of BBFC was measured. The change in the average number of bottles used per eye was recorded. The rate of adverse effects (AEs) of BBFC was recorded. A two-tailed paired sample t test was used to compare IOP prior to and after the introduction of BBFC for each eye. RESULTS: Mean change in IOP after BBFC introduction BBFC: - 2.76 mmHg (p < 0.0001). BBFC intolerance: 13%. On average there was a 0.24 reduction in the number of bottles of IOP-lowering medication used per eye (p < 0.0064). CONCLUSION: A switch to BBFC in the drop regimen is associated with a significant drop in IOP with reduced drop burden. Instead of a third IOP-lowering medication and bottle, a practitioner should consider using BBFC + prostaglandin analogue/FC drop for effective IOP control, reduced drop burden, reduced preservative load and increased likelihood of adherence. This study promotes the concept that any treatment should principally be assessed from the patients' perspective and quality of life.