Twice-daily brinzolamide 1%/brimonidine 0.2% fixed-dose combination as adjunctive to prostaglandin analogue in patients with open-angle glaucoma or ocular hypertension: a multinational, multicenter, Phase IV, randomised, 6 week study

Session Details

Session Title: Presented Poster Session: Glaucoma

Venue: Poster Village: Pod 2

First Author: : F.Topouzis GREECE

Co Author(s): :    M. Nicolela   F. Lerner   K. Bell   A. Tatham   P. Denis   I. Goldberg   A. Ridolfi   D. Hubatsch  

Abstract Details

Purpose:

Adjunctive treatment with prostaglandin analogue (PGA) and brinzolamide 1%/brimonidine 0.2% fixed-dose combination (BBFC), dosed thrice-daily, has been previously shown to provide clinically meaningful reduction in intraocular pressure (IOP) in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT) inadequately controlled with PGA monotherapy. The primary objective of this study was to determine the additive IOP-lowering effect of BBFC, when administered twice-daily (BID) as an adjunctive to PGA, in patients whose IOP was insufficiently controlled with PGA monotherapy [travoprost, latanoprost, or bimatoprost].

Setting:

A 6-week, multicenter (33 sites), randomized (1:1), double-masked, 2-arm, parallel-group study (NCT02419508).

Methods:

Adult OAG/OHT patients previously on PGA monotherapy for ≥28 days, with a mean IOP of ≥19 and <32mmHg (after washout from other medications) at 9:00h at 2 consecutive visits in at least one eye were randomized to receive BBFC+PGA or vehicle+PGA for 6 weeks. PGA was instilled once-daily (bedtime); BBFC/vehicle BID (9:00 and 21:00h). Primary endpoint: mean change in diurnal IOP from baseline (average of 9:00 and 11:00h measurements of both eligibility visits) at week 6. Secondary endpoints: mean percentage change in diurnal IOP from baseline; mean percentage change from baseline in IOP at each time-point, at week 6.

Results:

In total, 188 patients were randomized to the BBFC+PGA (n=96) and vehicle+PGA (n=92) groups, respectively; 187 (99.5%) were included in the full analysis set (FAS). The median age of patients was 68 years, 52.4% were female and 92% were Caucasian. The mean±SD diurnal IOP at baseline in the BBFC+PGA (22.8±2.39 mmHg) and vehicle+PGA (22.9±2.32 mmHg) groups were similar. The primary endpoint was met; the estimated mean change in diurnal IOP from baseline at week 6 was greater with BBFC+PGA (−5.59 mmHg) than with vehicle+PGA (−2.15 mmHg), with the treatment difference being statistically significant (−3.44 mmHg, 95% confidence interval, −4.2; −2.7; P<0.001). At week 6, the difference in mean percentage change (−15.1%; P<0.001) and mean change from baseline at the 09:00 h (−2.34 mmHg; P<0.001) and 11:00 h (−4.60 mmHg; P<0.001) time-points were also in favor of the BBFC+PGA group. Ocular AEs were reported in 21.1% and 8.7% of patients in the BBFC+PGA and vehicle+PGA groups, respectively. The most common ocular AE was ocular hyperemia (5.3%) in the BBFC+PGA group and blurred vision (2.2%) in the vehicle+PGA group.

Conclusions:

Adjunctive treatment with BBFC (BID) and PGA provided a significantly greater reduction in mean diurnal IOP from baseline than PGA alone, at week 6, in patients with OAG and OHT. The AEs with BBFC+PGA were consistent with the known safety profile of the individual medications.

Financial Disclosure:

is employed by a for-profit company with an interest in the subject of the presentation, research is funded, fully or partially, by a competing company, research is funded, fully or partially, by a company producing, developing or supplying the product or procedure presented, receives non-monetary benefits from a competing company., receives consulting fees, retainer, or contract payments from a competing company, receives consulting fees, retainer, or contract payments from a company producing, developing or supplying the product or procedure presented