Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as OTX-TKI (axitinib implant)
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...
OTX-TKI is an investigational intravitreal axitinib implant being developed for the treatment of neovascular age-related macular degeneration (nAMD), a condition that causes abnormal blood vessel growth and leakage in the retina. It is designed to be injected into the eye to deliver sustained drug levels over time.
OTX-TKI contains axitinib, a small molecule that inhibits vascular endothelial growth factor (VEGF) receptors. By blocking these receptors, axitinib aims to reduce abnormal blood vessel growth and vascular permeability in the retina, which are key drivers of vision loss in neovascular age-related macular degeneration.
OTX-TKI is being developed by Ocular Therapeutix, Inc., a biopharmaceutical company traded on NASDAQ under the ticker OCUL. The company is focused on ophthalmology and is advancing this intravitreal implant through clinical trials for neovascular age-related macular degeneration.
OTX-TKI is currently in Phase 3 clinical development for neovascular age-related macular degeneration. It is not yet approved by the FDA and remains investigational. Multiple Phase 3 trials are ongoing or planned to evaluate its efficacy and safety in patients with this condition.
OTX-TKI has been studied in several trials. A Phase 1 study (NCT03630315) is completed. Two Phase 3 trials, NCT06223958 and NCT06495918, are active but not recruiting. A third Phase 3 trial, NCT07516132, is recruiting to evaluate long-term safety in participants who completed prior studies.
Yes, OTX-TKI is also known as the axitinib implant. The drug name OTX-TKI refers to the intravitreal implant formulation of axitinib, a small molecule VEGF receptor inhibitor. This implant is designed for sustained release within the eye to treat neovascular age-related macular degeneration.