Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as OTX-TKI (axitinib implant)
OTX-TKI · 6 trials · 3 indications
Number of events
Percentage
The Diabetic Retinopathy Severity Scale (DRSS) measures the severity of the diabetic retinopathy in patients by grading retinal images obtained by color fundus photography. Severity is determined by the presence of specific signs.
Mean change in Best Corrected Visual Acuity (BCVA) from baseline at Week 48
Incidence and severity of treatment emergent adverse events
All adverse events from screening through end of study will be captured
| Arm | Type | Description |
|---|---|---|
| OTX-TKI | EXPERIMENTAL | - |
| OTX-TKI Q52W (single dose) | EXPERIMENTAL | OTX-TKI 0.45 mg via intravitreal (IVT) administration at Day 1 and sham procedure at Week 24 |
| OTX-TKI Q24W (2 doses) | EXPERIMENTAL | OTX-TKI 0.45 mg via IVT administration at Day 1 and Week 24 |
| Sham Q24W (control) | SHAM_COMPARATOR | Sham procedure at Day 1 and Week 24 |
| OTX-TKI Re-dose | EXPERIMENTAL | - |
| Aflibercept 2mg on label | ACTIVE_COMPARATOR | - |
| Aflibercept 8mg high dose | OTHER | - |
| OTX-TKI (axitinib implant) | EXPERIMENTAL | - |
| Control | OTHER | - |
| Aflibercept | ACTIVE_COMPARATOR | - |
| 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 |
| Single intravitreal injection of axitinib hydrogel implant followed by a mock (sham) injection procedure at Week 24 | DRUG | OTX-TKI 0.45 mg is a dried polyethylene glycol (PEG)-based hydrogel containing dispersed drug particles of the small molecule axitinib, a tyrosine kinase inhibitor (TKI). |
| Intravitreal injection of axitinib hydrogel implant followed by a second intravitreal injection of the axitinib implant at Week 24 | DRUG | OTX-TKI 0.45 mg is a dried polyethylene glycol (PEG)-based hydrogel containing dispersed drug particles of the small molecule axitinib, a tyrosine kinase inhibitor (TKI). |
| Sham/mock procedure of intravitreal injection followed by a second sham/mock procedure at Week 24 | OTHER | sham/mock intravitreal injection procedure |
| Aflibercept | DRUG | Intravitreal Injection of 2mg of aflibercept |
| OTX-TKI (axitinib implant) | DRUG | Intravitreal Injection of OTX-TKI (axitinib implant) |
| OTX-TKI/Sham | DRUG | OTX-TKI is one dose so subsequent visits will be sham to maintain the mask |
| Aflibercept/Sham | DRUG | Aflibercept administered every 8 weeks |
| 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 treatment being studied for two eye conditions: neovascular age-related macular degeneration (nAMD) and non-proliferative diabetic retinopathy. It is designed as an intravitreal hydrogel implant that delivers the small molecule axitinib. It is not yet approved for any indication and remains in Phase 3 clinical development.
OTX-TKI targets VEGFR, the vascular endothelial growth factor receptor. By inhibiting VEGFR, the axitinib payload aims to reduce abnormal blood vessel growth and leakage in the retina. This mechanism is relevant to both neovascular age-related macular degeneration and non-proliferative diabetic retinopathy, the two indications under study.
OTX-TKI is being developed by Ocular Therapeutix, Inc., which trades on the Nasdaq under the ticker OCUL. The company is responsible for the clinical program, including the Phase 3 trials in neovascular age-related macular degeneration and non-proliferative diabetic retinopathy.
OTX-TKI is in Phase 3 clinical development. It is investigational and has not been approved by the FDA for any indication. The Phase 3 program includes multiple trials, with three currently active and two completed, reflecting ongoing evaluation of efficacy and safety in the target patient populations.
OTX-TKI is being studied in several Phase 3 trials. These include NCT07516132, a long-term safety study in nAMD; NCT07235085, a trial in non-proliferative diabetic retinopathy; NCT06495918, a Phase 3 study in nAMD; and NCT06223958, another Phase 3 trial in nAMD. All are randomized, double-blind, and active-controlled.
Yes, OTX-TKI is also referred to as the axitinib implant or axitinib hydrogel implant. These names describe the same investigational product: a hydrogel implant that delivers axitinib via intravitreal injection. The various trial descriptions may use slightly different phrasing, but they all refer to the same OTX-TKI development program.