Efficacy of nepafenac ophthalmic suspension 0.1% in improving clinical outcomes following cataract surgery in patients with diabetes: an analysis of two randomized studies

Figures & data

Figure 1 Study design.

Abbreviation: NPDR, nonproliferative diabetic retinopathy.

Table 1 Demographic and baseline characteristics of patients in each treatment group by individual study and pooled data (FAS)

	Study 1		Study 2		Pooled
	Nepafenac 0.1%, n=126	Vehicle, n=125	Nepafenac 0.1%, n=80	Vehicle, n=80	Nepafenac 0.1%, n=205	Vehicle, n=206
Mean age, years (±SD)	66.6 (9.3)	66.4 (9.7)	68.1 (8.6)	69.4 (7.7)	67.2 (9.0)	67.5 (9.0)
Male, n (%)	42 (33.6)	51 (40.5)	51 (63.8)	44 (55.0)	93 (45.4)	95 (46.1)
Race, n (%)
White	97 (77.6)	108 (85.7)	69 (86.3)	71 (88.8)	166 (81.0)	179 (86.9)
Black/African–American	21 (16.8)	13 (10.3)	1 (1.3)	0 (0)	22 (10.7)	13 (6.3)
American Indian/Alaska Native	0 (0)	1 (0.8)	–	–	0 (0)	1 (0.5)
Asian	7 (5.6)	1 (0.8)	6 (7.5)	5 (6.3)	13 (6.3)	6 (2.9)
Native Hawaiian/other Pacific Islander	0 (0)	0 (0)	2 (2.5)	2 (2.5)	2 (1.0)	2 (1.0)
Other	0 (0)	3 (2.4)	2 (2.5)	2 (2.5)	2 (1.0)	5 (2.4)
CSMT, mean (±SD)	197.9 (26.6)	203.6 (24.8)	268.8 (29.0)	276.8 (23.2)	225.6 (44.2)	232.0 (43.1)
Mean BCVA (±SD)	68.2 (9.3)	66.7 (14.1)	62.5 (14.5)	64.3 (14.1)	65.9 (11.9)	65.8 (14.1)
Retinopathy severity, n (%)
Mild	19 (15.2)	26 (20.6)	58 (72.5)	57 (71.3)	77 (37.6)	83 (40.3)
Moderate	89 (71.2)	86 (68.3)	21 (26.3)	22 (27.5)	110 (53.7)	108 (52.4)
Severe	17 (13.6)	14 (11.1)	1 (1.3)	1 (1.3)	18 (8.8)	15 (7.3)

Abbreviations: BCVA, best-corrected visual acuity; CSMT, central subfield macular thickness; FAS, full analysis set; SD, standard deviation.

Figure 2 Percentage of patients with BCVA improvement of ≥15 letters from preoperative baseline to Day 14 and maintained through Day 90 in each treatment group by individual study and pooled data (FAS).

Notes: P-value (study 1: 0.003; study 2: 0.172; pooled: 0.001); *P<0.05.
Abbreviations: BCVA, best-corrected visual acuity; CI, confidence interval; FAS, full analysis set; OR, odds ratio; SE, standard error.

Figure 3 Percentage of patients with BCVA improvement of ≥15 letters from preoperative baseline and maintained through Day 90 in each treatment group by individual study and pooled data (FAS).

Notes: P-value (study 1: 0.001; study 2: 0.111; pooled: <0.001); *P<0.05.
Abbreviations: BCVA, best-corrected visual acuity; CI, confidence interval; FAS, full analysis set; OR, odds ratio; SE, standard error.

Figure 4 Percentage of patients with BCVA improvement of ≥15 letters from preoperative baseline and maintained through Day 60 in each treatment group by individual study and pooled data (FAS).

Notes: P-value (study 1: 0.046; study 2: 0.272; pooled: 0.025); *P<0.05.
Abbreviations: BCVA, best-corrected visual acuity; CI, confidence interval; FAS, full analysis set; OR, odds ratio; SE, standard error.

Table 2 Summary of BCVA outcomes in each treatment group by individual study and pooled data (FAS)

Endpoint	Nepafenac 0.1%, n (%)	Vehicle, n (%)	OR (95% CI)	P-value
Study 1	n=125	n=126
BCVA improvement of ≥15 letters from preoperative baseline to Day 14 and maintained through Day 90	48 (38.4)	27 (21.4)	2.4 (1.4, 4.2)	0.003*
BCVA improvement of ≥15 letters from preoperative baseline to Day 90	69 (55.2)	44 (34.9)	2.4 (1.4, 3.9)	0.001*
BCVA improvement of ≥15 letters from preoperative baseline to Day 60	65 (52.0)	50 (39.7)	1.7 (1.0, 2.8)	0.046*
BCVA >5-letter loss from Day 7 to any visit	19 (15.2)	54 (42.9)	0.2 (0.1, 0.4)	<0.001*
BCVA >10-letter loss from Day 7 to any visit	9 (7.2)	36 (28.6)	0.2 (0.1, 0.4)	<0.001*
Study 2	n=80	n=80
BCVA improvement of ≥15 letters from preoperative baseline to Day 14 and maintained through Day 90	28 (35.0)	20 (25.0)	1.6 (0.8, 3.2)	0.172
BCVA improvement of ≥15 letters from preoperative baseline to Day 90	38 (47.5)	28 (35.0)	1.7 (0.9, 3.2)	0.111
BCVA improvement of ≥15 letters from preoperative baseline to Day 60	42 (52.5)	35 (43.8)	1.4 (0.8, 2.6)	0.272
BCVA >5-letter loss from Day 7 to any visit	36 (45.0)	43 (53.8)	0.7 (0.4, 1.3)	0.274
BCVA >10-letter loss from Day 7 to any visit	30 (37.5)	37 (46.3)	0.7 (0.4, 1.3)	0.269
Pooled	n=205	n=206
BCVA improvement of ≥15 letters from preoperative baseline to Day 14 and maintained through Day 90	76 (37.1)	47 (22.8)	2.0 (1.3, 3.1)	0.001*
BCVA improvement of ≥15 letters from preoperative baseline to Day 90	107 (52.2)	72 (35.0)	2.0 (1.4, 3.0)	<0.001*
BCVA improvement of ≥15 letters from preoperative baseline to Day 60	107 (52.2)	85 (41.3)	1.6 (1.1, 2.3)	0.025*
BCVA >5-letter loss from Day 7 to any visit	55 (26.8)	97 (47.1)	0.4 (0.3, 0.6)	<0.001*
BCVA >10-letter loss from Day 7 to any visit	39 (19.0)	73 (35.4)	0.4 (0.3, 0.7)	<0.001*

Note:

* P<0.05.

Abbreviations: BCVA, best-corrected visual acuity; CI, confidence interval; FAS, full analysis set; OR, odds ratio.

Table 3 Mean BCVA at baseline and at each postoperative visit in each treatment group by individual study and pooled data (FAS)

BCVA	Study 1			Study 2			Pooled data
	Nepafenac 0.1%, (n=125)	Vehicle, (n=126)	P-value	Nepafenac 0.1%, (n=80)	Vehicle, (n=80)	P-value	Nepafenac 0.1%, (n=205)	Vehicle, (n=206)	P-value
Baseline BCVA
Mean (SD)	68.2 (9.3)	66.7 (14.1)		62.5 (14.5)	64.3 (14.1)		65.9 (11.9)	65.8 (14.1)
Day 7 (n)	125	121		80	80		205	201
Mean (SD)	81.3 (7.5)	80.4 (7.3)	0.412	77.5 (12.0)	79.3 (8.0)	0.325	79.8 (9.7)	80.0 (7.6)	0.856
Day 14 (n)	125	123		78	80		203	203
Mean (SD)	82.7 (7.4)	80.1 (7.6)	0.004*	78.6 (11.1)	79.0 (7.7)	0.825	81.1 (9.2)	79.6 (7.7)	0.073
Day 30 (n)	123	115		74	73		197	188
Mean (SD)	82.4 (9.2)	81.3 (6.7)	0.196	79.3 (13.5)	76.2 (18.2)	0.233	81.3 (11.1)	79.3 (12.7)	0.078
Day 60 (n)	117	111		68	66		185	177
Mean (SD)	83.9 (5.9)	82.0 (6.2)	0.055	80.7 (13.1)	79.0 (12.3)	0.253	82.7 (9.3)	80.8 (9.0)	0.047*
Day 90 (n)	119	103		66	54		185	157
Mean (SD)	84.2 (6.3)	82.7 (5.8)	0.092	76.3 (21.7)	81.3 (7.7)	0.208	81.4 (14.3)	82.2 (6.5)	0.784

Note:

* P<0.05.

Abbreviations: BCVA, best-corrected visual acuity; FAS, full analysis set; SD, standard deviation.