Across the GATHER clinical trials, IZERVAY reduced GA growth:
As early as 6 months2
Across all prespecified patient subgroups¶,11
Trial Design: The safety and efficacy of IZERVAY were demonstrated in GATHER1 and GATHER2: 2 randomized, multi-center, double-masked sham-controlled studies in patients with age-related macular degeneration (AMD). 292 patients were treated with IZERVAY 2 mg, and 332 patients received sham. The primary efficacy endpoint in both pivotal studies was the mean rate of GA growth (slope) from baseline to Month 12 over 3 timepoints: Baseline, Month 6, Month 12. In each study, over a 12-month period, there was a statistically significant reduction of the rate of GA growth (0.10 mm/year; p<0.01 in GATHER1 and 0.05 mm/year; p<0.01 in GATHER2 with square root transformed data) in patients treated with IZERVAY compared to sham.
IZERVAY post hoc analysis signaled reduction in risk of vision loss compared to sham12
Persistent vision loss in this pooled analysis was defined as a loss of ≥15 letters (ETDRS) in BCVA from baseline measured at any 2 consecutive visits up to Month 12, with a 56% risk reduction in persistent vision loss with IZERVAY vs sham
Cumulative Rate of Vision Loss
- Masked image and adverse event analysis completed to further ensure vision loss was consistent with disease progression1
- Given the exploratory, post hoc nature of the data, these results should be interpreted with caution and cannot be considered conclusive
IZERVAY was evaluated in patients with GA secondary to age-related macular degeneration (AMD)
The efficacy and safety of IZERVAY were evaluated in 2 randomized, multi-center, double-masked, sham-controlled clinical trials.1
In GATHER1 and GATHER2, patients were randomized to receive either intravitreal injections of IZERVAY or sham once monthly.
- Unifocal and multifocal
- Within 1500 μm from the foveal center
- Ranging in size from 2.5 mm2 to 17.5 mm2
Baseline patient demographics13
Baseline characteristics were balanced across trials and treatment arms
|
GATHER1
IZERVAY
(n=67)
|
GATHER1
Sham
(n=110)
|
GATHER2
IZERVAY
(n=225)
|
GATHER2
Sham
(n=222)
|
|
|---|---|---|---|---|
| Mean age, years (SD) | 78.8 (10.2) | 78.2 (8.8) | 76.3 (8.6) | 76.7 (8.8) |
| Female, n (%) | 45 (67.2) | 79 (71.8) | 154 (68.4) | 156 (70.3) |
| Caucasian, n (%) | 67 (100) | 107 (97.3) | 182 (80.9) | 186 (83.8) |
| Active smoker, n (%) | 25 (37.3) | 36 (32.7) | 106 (47.1) | 107 (48.2) |
| Mean total GA area, mm2 (SD)* | 7.33 (3.79) | 7.42 (3.84) | 7.48 (4.01) | 7.81 (3.89) |
| Mean square root GA area, mm2 (SD)* | 2.62 (0.70) | 2.63 (0.70) | 2.64 (0.71) | 2.71 (0.70) |
| Bilateral GA, n (%) | 67 (100) | 108 (98.2) | 212 (94.2) | 210 (94.6) |
| Mean BCVA, letters (SD)* | 70.2 (10.0) | 69.0 (10.4) | 70.9 (8.9) | 71.6 (9.4) |
| Mean LL-BCVA letters (SD)* | 36.7 (21.1) | 34.5 (19.3) | 41.0 (19.7) | 39.6 (19.6) |
~84% of patients had disease within 500 μm of the foveal center point13
Inclusion Criteria
- Age 50 years or above
- BCVA between 20/25 and 20/320
- GA lesion:
- Non-center point involving*
- Within 1500 μm from the foveal center
- Total area between 2.5 mm2 and 17.5 mm2 (1-7 DA, respectively)
- If multifocal lesions, at least 1 lesion had to be 1.25 mm2 (0.5 DA)
Exclusion Criteria
- Evidence of choroidal neovascularization (CNV) in either eye at baseline
- GA secondary to any condition other than AMD in either eye
- Any prior treatment for AMD or any prior intravitreal treatment for any indication in either eye (except oral vitamin or mineral supplements)
- Any ocular condition in study eye that could progress during the study and potentially affect central vision or otherwise act as a confounding factor
- Any sign of diabetic retinopathy in either eye
- MMRM=mixed models for repeated measures.
- Non-transformed GA growth slope analysis.1
- Percent difference is calculated by 100*(difference)/(least square mean from sham).1
- Patients were stratified by baseline GA area, baseline visual acuity (VA), funds autofluorescence (FAF) pattern, age, and gender.11