A combined analysis of four observational studies evaluating the intraocular pressure-lowering ability and tolerability of bimatoprost 0.01% in patients with primary open-angle glaucoma or ocular hypertension

Figures & data

Table 1 Patients’ demographic data at baseline

Patient characteristics	Mean ± SD	n	%*
Age (years)	66.7±12.5	2,495
Male		1,169	45.1
Female		1,407	54.3
Diagnosis
POAG		1,826	66.4
Both eyes		1,428	78.2
Right eye		110	6.0
Left eye		108	5.9
Not specified		180	9.9
OHT		925	33.6
Both eyes		712	77.0
Right eye		90	9.7
Left eye		65	7.0
Not specified		58	6.3
Mean IOP at baseline (mmHg)
Right eye	21.2±5.3	2,572
Left eye	21.2±5.2	2,575
Patients on prior therapy		1,386	53.5
Reason to prescribe bimatoprost 0.01%
Insufficient IOP control on prior therapy		917	31.4
Insufficient tolerability on prior therapy		414	14.2
Evidence of disease progression		331	11.3
Lack of adherence to prior therapy		101	3.5
Other		1,157	39.6

Note:

* Percentages may total more or less than 100% because of missing data or selection of more than one option for some patients.

Abbreviations: IOP, intraocular pressure; OHT, ocular hypertension; POAG, primary open-angle glaucoma; SD, standard deviation.

Figure 1 Mean IOP reductions at the final visit in (A) all patients; (B) patients without prior therapy, patients on a prior monotherapy, and patients on a prior fixed-combination therapy who continued on bimatoprost 0.01% monotherapy; and (C) patients switching from prior monotherapies to bimatoprost 0.01% monotherapy.

Notes: ^*P<0.0001 and ^**P<0.0003 comparing IOP from baseline with final visit. Error bars indicate standard deviations. Data from patients with complete data are shown.
Abbreviations: CAI, carbonic anhydrase inhibitor; IOP, intraocular pressure; PGA, prostaglandin analog.

Table 2 IOP data for study population and sub-populations

	Right eye					Left eye
	Patients with complete data (n)	Mean ± SD baseline IOP (mmHg)	Mean ± SD final IOP (mmHg)	Change in IOP from baseline to final visit (%)	P-value	Patients with complete data (n)	Mean ± SD baseline IOP (mmHg)	Mean ± SD final IOP (mmHg)	Change in IOP from baseline to final visit (%)	P-value
Total study population	2,446	21.2±5.3	16.2±3.7	−23.6	<0.0001	2,460	21.3±5.2	16.2±3.8	−23.9	<0.0001
No prior therapy*	1,119	23.3±5.0	16.6±3.7	−28.8	<0.0001	1,129	23.2±5.1	16.5±3.8	−28.9	<0.0001
Prior therapy*	737	19.2±4.5	16.0±3.6	−16.7	<0.0001	738	19.2±4.4	16.2±3.8	−15.6	<0.0001
Prior monotherapy*	596	19.2±4.6	15.9±3.3	−17.2	<0.0001	597	19.3±4.3	16.1±3.5	−16.7	<0.0001
Prior FC monotherapy*	95	19.0±4.0	16.3±4.3	−14.2	<0.0001	95	18.8±4.4	16.3±4.4	−13.3	<0.0001
Prior PGA monotherapy*	363	18.7±4.9	15.8±3.6	−15.5	<0.0001	361	18.6±5.4	15.9±3.5	−14.5	<0.0001
Prior latanoprost monotherapy*	186	19.0±4.7	16.0±3.7	−15.8	<0.0001	185	18.7±4.1	16.0±3.6	−14.4	<0.0001
Prior travoprost monotherapy*	99	18.9±5.4	15.7±3.5	−16.9	<0.0001	98	18.9±5.2	15.7±3.5	−16.9	<0.0001
Prior beta-blocker monotherapy*	185	20.1±3.8	16.2±3.0	−19.4	<0.0001	188	20.5±3.8	16.6±3.5	−19.0	<0.0001
Prior CAI monotherapy*	22	19.6±6.3	14.5±2.6	−26.0	<0.0003	22	19.3±4.3	14.9±3.1	−22.8	<0.0003

Notes:

* Patients switching to bimatoprost 0.01 monotherapy. Data from patients with complete data are shown.

Abbreviations: CAI, carbonic anhydrase inhibitor; FC, fixed combination; IOP, intraocular pressure; PGA, prostaglandin analog; SD, standard deviation.

Table 3 Adverse events experienced by ≥0.5% of patients in the total population (n=2,593)

Adverse event	n	%*
Conjunctival hyperemia	134	5.2
Eye irritation	123	4.7
Ocular hyperemia	77	3.0
Eye pruritus	63	2.4
Eye pain	24	0.9
Blepharal pigmentation	23	0.9
Increased growth of eyelashes	23	0.9
Headache	13	0.5
Dry eye disease	12	0.5
All adverse events	434	16.7

Note:

* Some patients (n=161) recorded >1 adverse event.