Biosimilar versus InnovAtor MoLecule of RAnibizumab in Neovascular Age-Related MaCular DEgeneration (The BALANCE Trial): Real-World Evidence

Figures & data

Figure 1 Flowchart of the selection process.

Table 1 Demographic and Baseline Characteristics of Patients

Characteristics	IRM (n = 87)	BRM (n = 77)	P value
Age (Years)	66.95±8.44, 64 (14)	66.27±8.43, 64 (11)	0.6357
Sex (Male)	40	36	1
BCVA (1st visit)	0.6 (0.3)	0.6 (0.3)	0.2937
CMT (1st visit)	401 (75) µm	400 (52) µm	0.2043
SRF (1st visit)	72 (82.76%)	59 (76.62%)	0.4337
IRF (1st visit)	63 (72.41%)	58 (75.32%)	0.8064

Table 2 Improvement in BCVA and CMT of Patients After Treatment

BCVA	IRM (n = 87)	BRM (n = 77)	P value
3 months	0.17 (0.3)	0.17 (0.13)	0.9158
6 months	0.3 (0.3)	0.3 (0.13)	0.06658
9 months	0.3 (0.24)	0.3 (0.3)	0.3576
12 months	0.3 (0.17)	0.3 (0.17)	0.857
CMT
3 months	259 (27)	260 (22)	0.9382
6 months	270 (26.5)	267 (23)	0.2187
9 months	276 (26)	276 (31)	0.916
12 months	283 (22)	284 (17)	0.1472

Figure 2 (A) Box plot showing Baseline and Treatment Period Visual Acuity (BCVA) for IRM. (B) Box plot showing Baseline and Treatment Period Visual Acuity (BCVA) for BRM.

Table 3 SRF and IRF Levels in Patients After Treatment

SRF	IRM (n = 87)	BRM (n = 77)	P value
3 months	23 (26.44%)	11 (14.29%)	0.08494
6 months	25 (28.74%)	14 (18.18%)	0.1613
9 months	36 (41.38%)	21 (27.27%)	0.08381
12 months	35 (40.23%)	27 (35.06%)	0.6035
IRF
3 months	15 (17.24%)	11 (14.29%)	0.7619
6 months	20 (22.99%)	13 (16.88%)	0.4365
9 months	27 (31.03%)	22 (28.57%)	0.8627
12 months	38 (43.68%)	32 (41.56%)	0.9079

Figure 3 (A) Box plot showing Baseline and Treatment Period CMT for IRM. (B) Box plot showing Baseline and Treatment Period CMT for BRM.

Table 4 Distribution of IRM and BRM Doses During 12 Months Study

Number of Doses	IRM (n = 87)	BRM (n = 77)	P value
5	6 (6.9%)	2 (2.3%)	0.615
6	27 (31.03%)	28 (32.18%)
7	45 (51.72%)	40 (45.98%)
≥8	9 (10.34%)	7 (8.05%)

Table 5 Adverse Events

Adverse Event	Frequency (%)
nsAE	IRM	BRM
Mild ocular pain	8	9
Burning sensation	9	10
Subconjunctival hemorrhage	3	4
Watering	9	9
sADR (Ocular)
RPE tears	2	1
Vitreous hemorrhage	1	–

Abbreviations: nsAE, non-serious adverse events; sADR, serious adverse drug reaction; RPE, retinal pigment epithelium.