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OPT-302 · 3 trials · 7 indications
Safety and Tolerability will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events and CTC v4.0 (if available, otherwise protocol defined grading were used)
Change from baseline in Best Corrected Visual Acuity (BCVA) will be measured at Week 12 according to Early Treatment Diabetic Retinopathy Score (ETDRS) criteria
Subject incidences of ophthalmic and systemic Adverse Events during study and follow-up period
| Arm | Type | Description |
|---|---|---|
| 0.5 mg ranibizumab with 2.0 mg OPT-302 | EXPERIMENTAL | 0.5 mg ranibizumab intravitreal injection (0.05 ml) followed by 2.0 mg OPT-302 intravitreal injection (0.05 ml) |
| 0.5 mg ranibizumab with 0.5 mg OPT-302 | EXPERIMENTAL | 0.5 mg ranibizumab intravitreal injection (0.05 ml) followed by 0.5 mg OPT-302 intravitreal injection (0.05 ml) |
| 0.5 mg ranibizumab with sham | SHAM_COMPARATOR | 0.5 mg ranibizumab intravitreal injection (0.05 ml) followed by sham |
| Ph 1b: 2.0 mg aflibercept with 0.3 mg OPT-302 | EXPERIMENTAL | 2.0 mg aflibercept intravitreal injection (0.05 mL) followed by 0.3 mg OPT-302 intravitreal injection (0.05 mL) |
| Ph 1b: 2.0 mg aflibercept with 1.0 mg OPT-302 | EXPERIMENTAL | 2.0 mg aflibercept intravitreal injection (0.05 mL) followed by 1.0 mg OPT-302 intravitreal injection (0.05 mL) |
| Ph 1b: 2.0 mg aflibercept with 2.0 mg OPT-302 | EXPERIMENTAL | 2.0 mg aflibercept intravitreal injection (0.05 mL) followed by 2.0 mg OPT-302 intravitreal injection (0.05 mL) |
| Ph 2a: 2.0 mg aflibercept with 2.0 mg OPT-302 | EXPERIMENTAL | 2.0 mg aflibercept intravitreal injection (0.05 mL) followed by 2.0 mg OPT-302 intravitreal injection (0.05 mL) |
| Ph 2a: 2.0 mg aflibercept with sham | SHAM_COMPARATOR | 2.0 mg aflibercept intravitreal injection (0.05 mL) followed by sham intravitreal injection |
| Part 1 Dose escalation - Cohort 1 | EXPERIMENTAL | Dose Level 1 of OPT-302 in combination with Lucentis™ |
| Part 1 Dose escalation - Cohort 2 | EXPERIMENTAL | Dose Level 2 of OPT-302 in combination with Lucentis™ |
| Part 1 Dose escalation - Cohort 3 | EXPERIMENTAL | Dose Level 3 of OPT-302 in combination with Lucentis™ |
| Part 1 Dose escalation - Cohort 4 | EXPERIMENTAL | Dose Level 3 of OPT-302 monotherapy |
| Part 2 Dose expansion - Cohort 5 | EXPERIMENTAL | OPT-302 (at Maximum Tolerated Dose \[MTD\] or highest dose tested in Part 1) in combination with Lucentis™ |
| Part 2 Dose expansion - Cohort 6 | EXPERIMENTAL | OPT-302 (at MTD or highest dose tested in Part 1) monotherapy |
| Name | Type | Description |
|---|---|---|
| OPT-302 | BIOLOGICAL | Intravitreal injection |
| ranibizumab | BIOLOGICAL | Intravitreal injection |
| sham intravitreal injection | OTHER | Sham (mock) intravitreal injection |
| Aflibercept | BIOLOGICAL | Intravitreal injection |
| Lucentis™ | DRUG | Lucentis™ (0.5 mg) will be administered by intravitreal injection once every month for 3 months |
Inclusion Criteria: * Active subfoveal choroidal neovascular (CNV) lesion or juxtafoveal lesion secondary to age-related macular AMD * An ETDRS BCVA score between 60 and 25 (inclusive) letters Exclusion Criteria: * Previous treatment for wet AMD or previous treatment for CNV due to other causes i...
OPT-302 is an investigational monoclonal antibody developed by Opthea Limited for retinal eye diseases. It has been studied in diabetic macular edema and neovascular age-related macular degeneration, where it is given in combination with standard anti-VEGF therapies such as aflibercept and ranibizumab. It remains in clinical development.
OPT-302 has been studied in diabetic macular edema as an add-on to aflibercept in patients with persistent disease. A completed Phase 1 dose-ranging trial, NCT03397264, enrolled 153 patients across the United States, Australia, Israel and Latvia. OPT-302 is investigational and has not been approved for this indication.
OPT-302 is developed by Opthea Limited, an ophthalmology-focused biopharmaceutical company whose shares trade under the ticker OPT. Opthea has run the clinical program for OPT-302, including dose-ranging studies in diabetic macular edema and neovascular age-related macular degeneration.
OPT-302 is an investigational drug that has completed Phase 1 and Phase 2 clinical testing. Its clinical program includes a completed Phase 1 study in wet AMD, a completed Phase 1 dose-ranging study in diabetic macular edema, and a completed Phase 2 dose-ranging study in neovascular age-related macular degeneration. It has not been approved by the FDA.
Three completed trials have evaluated OPT-302: NCT02543229, a Phase 1 study of OPT-302 with or without Lucentis in wet AMD; NCT03397264, a Phase 1 dose-ranging study with aflibercept in persistent diabetic macular edema; and NCT03345082, a Phase 2 dose-ranging study with ranibizumab in neovascular age-related macular degeneration.
OPT-302 is a monoclonal antibody designed to bind vascular endothelial growth factor C and D, blocking these VEGF family ligands. By inhibiting VEGF-C and VEGF-D alongside standard anti-VEGF-A therapy, it is intended to provide broader suppression of the angiogenic signaling that drives retinal vascular leakage and abnormal vessel growth in diseases such as diabetic macular edema and wet AMD.