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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...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| EyePoint, Inc. | EYPT | 2 | PHASE3 | EYP-1901 |
| 4D Molecular Therapeutics, Inc. | FDMT | 2 | PHASE3 | 4D-150, EYELEA |
| Regeneron Pharmaceuticals, Inc. | REGN | 1 | PHASE3 | Aflibercept |
| Hoffmann-La Roche | RHHBY | 6 | PHASE3 | Ranibizumab, Susvimo, RO7497372, RO7823653, Faricimab |
| Merck & Co., Inc. | MRK | 2 | PHASE3 | MK-8748 |
| AbbVie, Inc. | ABBV | 2 | PHASE2 | Surabgene Lomparvovec |
| Outlook Therapeutics, Inc. | OTLK | 1 | PHASE3 | ONS-5010 |
| Kodiak Sciences, Inc. | KOD | 1 | PHASE3 | Tabirafusp tedromer |
| Alvotech | ALVO | 1 | PHASE3 | AVT29 |
| Kiora Pharmaceuticals, Inc. | KPRX | 1 | PHASE2 | KIO-104 |
| REGENXBIO, Inc. | RGNX | 1 | PHASE2 | RGX-314 |
| BioAge Labs, Inc. | BIOA | 1 | PHASE2 | BGE-102 |
| Ocugen Inc | OCGN | 1 | PHASE1 | OCU200 |
| Surrozen Inc | SRZN | 1 | PHASE1 | SZN-8141 |
| Adverum Biotechnologies, Inc. | ADVM | 1 | - | ADVM-022 |
| Bayer | BAYRY | 1 | - | Aflibercept |
OPT-302 is an investigational biologic being studied in ophthalmology for diabetic macular edema and neovascular age-related macular degeneration. Clinical trials have evaluated OPT-302 given in combination with anti-VEGF agents such as aflibercept and ranibizumab in patients with these retinal diseases.
OPT-302 is being developed by Opthea Limited, an ophthalmology-focused biopharmaceutical company. Opthea trades under the ticker CYVNY. The company has sponsored the clinical studies of OPT-302 in diabetic macular edema and neovascular age-related macular degeneration.
OPT-302 has been studied in Phase 1 and Phase 1/2 clinical trials, which have completed. It is an investigational therapy and is not described as FDA approved. The completed studies covered dose ranging in diabetic macular edema and neovascular age-related macular degeneration, plus an earlier safety and pharmacokinetics study.
OPT-302 has been evaluated in three completed studies. NCT03397264 was a Phase 1/2 dose-ranging study of OPT-302 with aflibercept in persistent diabetic macular edema, enrolling 153 patients. NCT03345082 was a Phase 2 dose-ranging study with ranibizumab in neovascular AMD, enrolling 366 patients. NCT02543229 was a Phase 1 safety, pharmacokinetics and pharmacodynamics study in wet AMD.
The OPT-302 studies were randomized, double-blind and sham-controlled, and enrolled adults only. The diabetic macular edema study required participants aged 18 years and older, while the neovascular AMD studies required participants aged 50 years and older. The trials took place across sites in the United States, Australia, Israel, Latvia, Czechia, France, Hungary, Italy, Poland, Spain and the United Kingdom.