Efficacy of a preservative-free formulation of fixed-combination bimatoprost and timolol (Ganfort PF) in treatment-naïve patients vs previously treated patients

Figures & data

Figure 1 Patient disposition in the Phase III study comparing FCBT PF with FCBT.

Abbreviations: FCBT PF, preservative-free formulation of fixed-combination bimatoprost 0.03%/timolol 0.5%; FCBT, fixed-combination bimatoprost 0.03%/timolol 0.5%; ITT, intent-to-treat; PP, per protocol.

Figure 2 Changes in average eye IOP from baseline in treatment-naïve vs previously treated patients who received FCBT PF.

Note: *P≤0.05 vs previously treated.
Abbreviations: IOP, intraocular pressure; FCBT PF, preservative-free formulation of fixed-combination bimatoprost 0.03%/timolol 0.5%.

Figure 3 Changes in average eye IOP from baseline in treatment-naïve vs previously treated patients who received FCBT.

Abbreviations: IOP, intraocular pressure; FCBT, fixed-combination bimatoprost 0.03%/timolol 0.5%.

Table 1 Patients’ baseline characteristics that affect IOP lowering in the post hoc analysis

Characteristic	FCBT PF			FCBT
	Treatment-naïve (N=50)	Previously treated (N=228)	P-valuea	Treatment-naïve (N=60)	Previously treated (N=221)	P-valuea
Mean age, y (range)	59.0 (20–81)	64.6 (29–85)	<0.001	58.2 (29–81)	65.0 (23–86)	<0.001
Diagnosis, N (%)			<0.001			<0.001
OHT	22 (44.0)	33 (14.5)		23 (38.3)	32 (14.5)
Glaucoma	27 (54.0)	193 (84.6)		36 (60.0)	183 (82.8)
1 diagnosis in each eye	1 (2.0)	2 (0.9)		1 (1.7)	6 (2.7)
Corneal thickness, µm (SD)b	556 (25)	551 (27)	0.484	564 (24)	553 (28)	0.007
IOP, mmHg (SD)b
Hour 0	25.4 (1.9)	24.8 (2.2)	0.66	25.1 (1.8)	24.8 (2.2)	0.62
Hour 2	25.1 (2.0)	24.1 (2.6)	0.40	24.5 (2.0)	24.2 (2.5)	0.79
Hour 8	23.9 (2.2)	23.3 (3.0)	0.19	23.7 (2.2)	23.3 (2.8)	0.68

Notes:

a Comparison of treatment-naïve vs previously treated patients.

b Mean average eye IOP.

Abbreviations: IOP, intraocular pressure; FCBT PF, preservative-free formulation of fixed-combination bimatoprost 0.03%/timolol 0.5%; FCBT, fixed-combination bimatoprost 0.03%/timolol 0.5%; y, years; OHT, ocular hypertension; SD, standard deviation.

Table 2 Adverse events in treatment-naïve and previously treated patients

Adverse event, N (%)	FCBT PF		FCBT
	Treatment-naïve (N=50)	Previously treated (N=228)	Treatment-naïve (N=60)	Previously treated (N=220)
Conjunctival hyperemia	11 (22.0)	48 (21.1)	10 (16.7)	45 (20.5)
Eye pruritus	4 (8.0)	8 (3.5)	2 (3.3)	3 (1.4)
Skin hyperpigmentation	4 (8.0)	7 (3.1)	2 (3.3)	2 (0.9)
Dry eye	4 (8.0)	5 (2.2)	2 (3.3)	1 (0.5)
Eye pain	4 (8.0)a	3 (1.3)	1 (1.7)	4 (1.8)
Punctate keratitis	2 (4.0)	6 (2.6)	2 (3.3)	5 (2.3)
Growth of eyelashes	2 (4.0)	2 (0.9)	4 (6.7)	4 (1.8)
Influenza	2 (4.0)a	0	0	0
Eye irritation	1 (2.0)	5 (2.2)	2 (3.3)	3 (1.4)
Foreign body sensation	1 (2.0)	5 (2.2)	2 (3.3)	4 (1.8)

Notes: All adverse events with an incidence >2.0% in either subgroups are reported.

a P≤0.032 vs previously treated patients.

Abbreviations: FCBT PF, preservative-free formulation of fixed-combination bimatoprost 0.03%/timolol 0.5%; FCBT, fixed-combination bimatoprost 0.03%/timolol 0.5%.