Corrections for Macugen Briefing Document (NDA 21-756). 

 

 

 

Page 18 of briefing document:

 

 

Primary Efficacy Results – PP population observed cases only– Study 1003

 

Number of Patients (%)

0.3 mg

 

1 mg

 

3 mg

 

Sham

 

Responders1

Month 3

122 (87.8%)

N=139

131 (92.9%)

N= 141

122 (86.5%)

N= 141

120 (82.8%)

N= 145

Month 6

110 (85.3%)

N= 129

125 (86.8%)

N= 144

116 (82.3%)

N= 141

101 (69.7%)

N= 145

Month 9

103 (78.3%)

N= 131

115 (79.9%)

N= 144

110 (79.1%)

N= 139

93 (66%)

N= 141

Month 12

98 (73.7%)

p=0.01

N= 133

105 (75.5%)

p=0.005

N= 139

90 (66.7%)

N= 135

82 (58.6%)

N= 140

1 Patients who lost < 15 letters of vision.  Note:  Patients who lost < 15 letters of vision from baseline to 54 weeks is the primary efficacy endpoint

2  3 mg dose was omitted from statistical analysis prior to unmasking data

 

 

 

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