# Presentation: 665779

## Questions and Answers

## 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 | 278 | 149 | 250 | 281 |
| 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**

## 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

## 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%(0/0) | 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**

## 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**

## 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**

## 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**

## 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%) |
| Rhegmatogenous | 0 | 0 | 0 | 2 (1.0%) |
| Traction / Rhegmatogenous | 0 | 1 (0.6%) | 1 (0.6%) | 1 (0.5%) |
| Unspecified | 6 (3.1%) | 10 (5.6%) | 5 (2.9%) | 11 (5.7%) |

- Vit-02

## 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%) |
| Rhegmatogenous | 0 | 1 (0.5%) | 0 |
| Traction / Rhegmatogenous | 1 (0.5%) | 1 (0.5%) | 0 |
| Unspecified | 9 (4.8%) | 11 (6.0%) | 16 (8.9%) |

- Vit-03

## Retinal Detachment Prior to Vitrectomy(Time to Diagnosis)

**Vitrase Integrated Phase III Data**

## 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 |

## 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) |  |
| --- | --- | --- | --- | --- | --- |
| N | 0 | 1 | 6 |  | 21 |
| Mean (days) | NA | 19 | 8 |  | 10 |

## 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 | 126 | 123 | 222 | 243 |
| 	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%) |

## 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 | 109 | 75 | 148 | 149 |
| 	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%) |

## Improvement in BCVALife Table Analysis

**Vitrase Integrated Phase III Data**

## 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%) |

## 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%) |

## 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%) |

## 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**

## 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**

## 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 (1.6%) | 3 (1.7%) |
| > 90 | 10 (5.3%) | 5 (2.7%) | 16 (8.9%) |

**Vit 03 – Ex North America**