Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
OPT-302 · 2 trials · 6 indications
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 |
| 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 |
| 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 small molecule being developed for eye diseases, specifically neovascular age-related macular degeneration (wet AMD). It is designed for use in patients with this condition, which involves abnormal blood vessel growth in the retina. OPT-302 is currently in clinical development and is not yet approved by regulatory authorities.
OPT-302 is being developed by Opthea Limited, a biopharmaceutical company listed on the Australian Securities Exchange under the ticker symbol OPT. The company is conducting clinical trials to evaluate the safety and efficacy of OPT-302 in patients with neovascular age-related macular degeneration.
OPT-302 has completed Phase 1 and Phase 2 clinical trials. The Phase 1 study evaluated safety, pharmacokinetics, and pharmacodynamics, while the Phase 2 study was a dose-ranging trial. Both trials are completed, and OPT-302 remains an investigational drug in clinical development, not yet approved for commercial use.
OPT-302 has been studied in two completed clinical trials. The first, NCT02543229, was a Phase 1 study evaluating safety, pharmacokinetics, and pharmacodynamics with or without Lucentis in patients with wet AMD. The second, NCT03345082, was a Phase 2 dose-ranging study of OPT-302 with ranibizumab in neovascular AMD.
No, OPT-302 is a distinct investigational drug being developed by Opthea Limited. In clinical trials, it has been studied in combination with Lucentis (ranibizumab), which is an approved treatment for wet AMD. OPT-302 is not the same as ranibizumab; it is a separate agent being evaluated for its potential additive benefit.