Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
OTX-TKI · 4 trials · 2 indications
Number of events
Percentage
Mean change in Best Corrected Visual Acuity (BCVA) from baseline at Week 48
All adverse events from screening through end of study will be captured
| Arm | Type | Description |
|---|---|---|
| OTX-TKI | EXPERIMENTAL | - |
| OTX-TKI Re-dose | EXPERIMENTAL | - |
| Aflibercept 2mg on label | ACTIVE_COMPARATOR | - |
| Aflibercept 8mg high dose | OTHER | - |
| OTX-TKI (axitinib implant) | EXPERIMENTAL | - |
| Control | OTHER | - |
| Cohort 1 (Low Dose) | EXPERIMENTAL | Subjects will receive a low dose of OTX-TKI |
| Cohort 2 (Middle Dose) | EXPERIMENTAL | Subjects will receive a middle dose of OTX-TKI. |
| Cohort 3 (High Dose) | EXPERIMENTAL | Subjects will receive a high dose of OTX-TKI. |
| Cohort 3 (Anti-VEGF) | EXPERIMENTAL | Subjects will receive OTX-TKI plus a single anti-VEGF injection |
| Cohort 4 (High Dose) | EXPERIMENTAL | Subjects will receive a high dose of OTX-TKI. |
| Cohort 4 (Anti-VEGF) | EXPERIMENTAL | Subjects will receive OTX-TKI plus a single anti-VEGF injection |
| Name | Type | Description |
|---|---|---|
| OTX-TKI | DRUG | Intravitreal Injection of OTX-TKI |
| Aflibercept | DRUG | Intravitreal Injection of 2mg of aflibercept |
| OTX-TKI (axitinib implant) | DRUG | Intravitreal Injection of OTX-TKI (axitinib implant) |
| Anti-VEGF | DRUG | Standard of care therapy used to block vascular endothelial growth factor |
Inclusion Criteria: * Participants with a diagnosis of nAMD in the study eye who successfully completed Study OTX-TKI-2023-AMD-301 through Week 104 or Study OTX-TKI-2023-AMD-303 through Week 96 * Have adequate ocular media and adequate pupillary dilation in the study eye to permit good quality fund...