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P-1 Questions and Answers. P-2 PDR as Reason for Hemorrhage Any Laser Therapy Prior to Vitrectomy Saline Control 7.5 IU Vitrase 55 IU Vitrase 75 IU Vitrase.

Published byNigel Neal Modified over 9 years ago

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Presentation on theme: "P-1 Questions and Answers. P-2 PDR as Reason for Hemorrhage Any Laser Therapy Prior to Vitrectomy Saline Control 7.5 IU Vitrase 55 IU Vitrase 75 IU Vitrase."— Presentation transcript:

1 P-1 Questions and Answers

2 P-2 PDR as Reason for Hemorrhage Any Laser Therapy Prior to Vitrectomy Saline Control 7.5 IU Vitrase 55 IU Vitrase 75 IU Vitrase With PDR 278149250281 Laser Therapy: At Month 1 22 (7.9%) 32 (21.5%) 42 (16.8%) 44 (15.7%) At Month 2 24 (8.6%) 22 (14.8%) 29 (11.6%) 28 (10.0%) At Month 3 23 (8.3%) 10 (6.7%) 13 (5.2%) 15 (5.3%) Vitrase Integrated Phase III Data

3 P-3 Recurrent Vitreous Hemorrhage All Incidents (Severity) After Injection Saline Control (N = 191) 7.5 IU Vitrase (N = 180) 55 IU Vitrase (N = 175) 75 IU Vitrase (N = 194) Mild 15 (7.9%) 15 (8.3%) 13 (7.4%) 15 (7.7%) Moderate (p=0.054) 13 (6.8%) 26 (14.4%) 22 (12.6%) 16 (8.2%) Severe (p=0.266) 13 (6.8%) 23 (12.8%) 19 (10.9%) 20 (10.3%) Vit-02

4 P-4 Reduction in Hemorrhage Density by 3 Months (Screening Lens Status) Screening Lens Status Saline Control (N = 383) 7.5 IU Vitrase (N = 181) 55 IU Vitrase (N = 365) 75 IU Vitrase (N = 377) Aphakia 0.0% (0/2) 0.0% (0/0) 0.0% (0/1) Pseudophakia 35.7% (20/56) 36.8% (14/38) 50.0% (25/50) 40.6% (28/69) Phakia 27.6% (89/323) 35.2% (50/142) 36.9% (116/314) 37.9% (116/306) Vitrase Integrated Phase III Data

5 P-5 Achieved BCVA of LogMAR 1.0 or Better Cumulative Percentages Saline Control (N = 383) 7.5 IU Vitrase (N = 181) 55 IU Vitrase (N = 365) 75 IU Vitrase (N = 377) Month 1 52 (13.6%) 43 (23.8%) P = 0.004 79 (21.6%) P = 0.005 84 (22.3%) P = 0.002 Month 2 84 (21.9%) 50 (27.6%) P = 0.169 116 (31.8%) P = 0.003 116 (30.8%) P = 0.007 Month 3 108 (28.2%) 56 (30.9%) P = 0.569 133 (36.4%) P = 0.020 135 (35.8%) P = 0.030 Vitrase Integrated Phase III Data

6 P-6 Achieved BCVA of LogMAR 1.0 or Better Cumulative Percentages Saline Control (N = 193) 7.5 IU Vitrase (N = 181) 55 IU Vitrase (N = 179) 75 IU Vitrase (N = 197) Month 1 22 (11.4%) 43 (23.8%) P = 0.003 37 (20.7%) P = 0.021 50 (25.4%) P = 0.001 Month 2 42 (21.8%) 50 (27.6%) P = 0.232 57 (31.8%) P = 0.037 65 (33.0%) P = 0.018 Month 3 54 (28.0%) 56 (30.9%) P = 0.607 64 (35.8%) P = 0.134 75 (38.1%) P = 0.044 Vit 02 – North America

7 P-7 Achieved BCVA of LogMAR 1.0 or Better Cumulative Percentages Saline Control (N = 190) 55 IU Vitrase (N = 186) 75 IU Vitrase (N = 180) Month 1 30 (15.8%) 42 (22.6%) P = 0.123 34 (18.9%) P = 0.515 Month 2 42 (22.1%) 59 (31.7%) P = 0.047 51 (28.3%) P = 0.208 Month 3 54 (28.4%) 69 (37.1%) P = 0.092 60 (33.3%) P = 0.363 Vit 03 – Ex North America

8 P-8 Retinal Detachment (Type of Detachment) Type of Detachment Saline Control (N = 191) 7.5 IU Vitrase (N = 180) 55 IU Vitrase (N = 175) 75 IU Vitrase (N = 194) Traction 5 (2.6%) 9 (5.0%) 13 (7.4%) 12 (6.2%) Rhegmatogenous000 2 (1.0%) Traction / Rhegmatogenous 0 1 (0.6%) 1 (0.5%) Unspecified 6 (3.1%) 10 (5.6%) 5 (2.9%) 11 (5.7%) Vit-02

9 P-9 Retinal Detachment (Type of Detachment) Type of Detachment Saline Control (N = 187) 55 IU Vitrase (N = 184) 75 IU Vitrase (N = 180) Traction 5 (2.7%) 1 (0.5%) 4 (2.2%) Rhegmatogenous0 1 (0.5%) 0 Traction / Rhegmatogenous 1 (0.5%) 0 Unspecified 9 (4.8%) 11 (6.0%) 16 (8.9%) Vit-03

10 P-10 Retinal Detachment Prior to Vitrectomy (Time to Diagnosis) Vitrase Integrated Phase III Data

11 P-11 Breslow-Day P-Values 55 IU vs Saline Measurement Month 1 Month 2 Month 3 Reduction in Hemorrhage Density P = 0.9213 P = 0.9461 P = 0.6677 Improvement in BCVA P = 0.8642 P = 0.8452 P = 0.3720 Outcome by Investigator P = 0.3608 P = 0.6991 P = 0.7758 Surrogate Success P = 0.9338 P = 0.2028 P = 0.9126

12 P-12 Hypopyon Duration Vitrase Integrated Phase III Data Saline Control (N = 378) 7.5 IU Vitrase (N = 198) 55 IU Vitrase (N = 377) 75 IU Vitrase (N = 391) N01621 Mean (days) NA19810

13 P-13 Iritis by Reduction in Hemorrhage Density Vitrase Integrated Phase III Data Saline Control 7.5 IU Vitrase 55 IU Vitrase 75 IU Vitrase Patients with Iritis 126123222243 With Reduction 33 (26.2%) 43 (35.0%) 95 (42.8%) 102 (42.0%) Iritis on or Prior to Reduction 33 (26.2%) 39 (31.7%) 92 (41.4%) 101 (41.6%)

14 P-14 Reduction in Hemorrhage Density by Iritis Vitrase Integrated Phase III Data Saline Control 7.5 IU Vitrase 55 IU Vitrase 75 IU Vitrase Patients with Reduction 10975148149 With Iritis 33 (30.3%) 43 (57.3%) 95 (64.2%) 102 (68.5%) Reduction on or After Iritis 33 (30.3%) 39 (52.0%) 92 (62.2%) 101 (67.8%)

15 P-15 Improvement in BCVA Life Table Analysis Vitrase Integrated Phase III Data

16 P-16 Retinal Detachment After and Prior to Vitrectomy Vitrase Integrated Phase III Data Patients with: Saline Control (N = 378) 7.5 IU Vitrase (N = 198) 55 IU Vitrase (N = 377) 75 IU Vitrase (N = 391) RD 26 (6.9%) 22 (11.1%) 35 (9.3%) 45 (11.5%) RD and Vitrectomy 18 (4.8%) 21 (10.6%) 27 (7.2%) 38 (9.7%) RD after Vitrectomy 10 (2.6%) 11 (5.6%) 13 (3.4%) 22 (5.6%) RD prior to Vitrectomy 8 (2.1%) 10 (5.1%) 14 (3.7%) 16 (4.1%)

17 P-17 Retinal Detachment After and Prior to Vitrectomy Vit 02 – North America Patients with: Saline Control (N = 191) 7.5 IU Vitrase (N = 180) 55 IU Vitrase (N = 175) 75 IU Vitrase (N = 194) RD 11 (5.8%) 19 (10.6%) 18 (10.3%) 23 (11.9%) RD and Vitrectomy 9 (4.7%) 18 (10.0%) 16 (9.1%) 21 (10.8%) RD after Vitrectomy 4 (2.1%) 9 (5.0%) 10 (5.7%) 13 (6.7%) RD prior to Vitrectomy 5 (2.6%) 9 (5.0%) 6 (3.4%) 8 (4.1%)

18 P-18 Retinal Detachment After and Prior to Vitrectomy Vit 03 – Ex North America Patients with: Saline Control (N = 187) 55 IU Vitrase (N = 184) 75 IU Vitrase (N = 180) RD 15 (8.0%) 13 (7.1%) 18 (10.0%) RD and Vitrectomy 9 (4.8%) 7 (3.8%) 13 (7.2%) RD after Vitrectomy 6 (3.2%) 1 (0.5%) 6 (3.3%) RD prior to Vitrectomy 3 (1.6%) 6 (3.3%) 7 (3.9%)

19 P-19 Retinal Detachment (Time to Diagnosis) Days from Injection Saline Control (N = 378) 7.5 IU Vitrase (N = 198) 55 IU Vitrase (N = 377) 75 IU Vitrase (N = 391) < 31 2 (0.5%) 2 (1.0%) 7 (1.9%) 2 (0.5%) 31 – 60 4 (1.1%) 1 (0.5%) 3 (0.8%) 5 (1.3%) 61 – 90 6 (1.6%) 5 (2.5%) 6 (1.6%) 9 (2.3%) > 90 15 (4.0%) 16 (8.1%) 22 (5.8%) 35 (9.0%) Vitrase Integrated Phase III Data

20 P-20 Retinal Detachment (Time to Diagnosis) Days from Injection Saline Control (N = 191) 7.5 IU Vitrase (N = 180) 55 IU Vitrase (N = 175) 75 IU Vitrase (N = 194) < 31 2 (1.0%) 1 (0.6%) 0 (0.0%) 2 (1.0%) 31 – 60 1 (0.5%) 1 (0.6%) 2 (1.1%) 2 (1.0%) 61 – 90 3 (1.6%) 5 (2.8%) 2 (1.1%) 4 (2.1%) > 90 5 (2.6%) 14 (7.8%) 14 (8.0%) 17 (8.8%) Vit 02 – North America

21 P-21 Retinal Detachment (Time to Diagnosis) Days from Injection Saline Control (N = 187) 55 IU Vitrase (N = 184) 75 IU Vitrase (N = 180) < 31 0 (0.0%) 7 (3.8%) 0 (0.0%) 31 – 60 3 (1.6%) 1 (0.5%) 3 (1.7%) 61 – 90 3 (1.6%) 3 (1.7%) > 90 10 (5.3%) 5 (2.7%) 16 (8.9%) Vit 03 – Ex North America

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