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22-11-2018 | Ophthalmology | News | Article

Fixed-combination BBFC improves 24-hour intraocular pressure after 4 weeks

medwireNews: Treatment with fixed-combination brinzolamide 1%/brimonidine 0.2% (BBFC) for 4 weeks significantly reduces 24-hour intraocular pressure (IOP) in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT), US researchers report.

Robert Weinreb (University of California, San Diego) and colleagues believe that their study is the “first large, multicenter, randomized, double-masked trial to evaluate the effect of an IOP-lowering medication over a 24-hour period in subjects diagnosed with either OAG or OHT.”

It included 123 individuals with OAG or OHT aged 18 years or older, with mean baseline IOP measurements in at least one eye of 21 mmHg or higher but below 28 mmHg.

Prior to treatment initiation, mean pneumatonometer IOP measurements were collected in each eye every 2 hours over a 24-hour period under controlled light conditions. Measurements were taken in a sitting position during daytime hours (08:00–20:00) and in a supine position during nocturnal hours (22:00–06:00).

The measurements were repeated under the same conditions at the end of 4 weeks of treatment with either BBFC (n=62) or vehicle (n=61), given as one drop three times daily (08:00, 15:00, 22:00).

The researchers report that 24-hour least squares mean reduction in IOP at 4 weeks was significantly greater among the individuals who were randomly assigned to receive BBFC than among those assigned to receive vehicle, at 3.1 versus 0.6 mmHg.

The reduction was significant for all seven daytime measurements and for three of the five nighttime ones (22:00, 0:00, 06:00).

The overall reduction in daytime IOP at 4 weeks was therefore significantly greater with BBFC than with vehicle (3.9 vs 0.5 mmHg), while the difference between the groups was of borderline significance for the nocturnal measurements (1.9 vs 0.7 mmHg). These equated to reductions from baseline of 14–22% during the daytime period and 6–9% during the nocturnal period.

During the study, 23% of participants in the BBFC group and 18% of those in the vehicle group experienced at least one treatment-emergent adverse event. In the BBFC arm these were most commonly ocular hyperaemia, corneal abrasion and dysgeusia, whereas conjunctival hyperaemia and eye pruritus were most common in the vehicle group.

Writing in Ophthalmology, Weinreb and co-authors conclude that BBFC “demonstrated superior 24-hour IOP-lowering efficacy compared with Vehicle over 4 weeks in subjects with OAG or OHT […] with no new safety signals identified.”

 By Laura Cowen

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