Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Aflibercept · 1 trial · 1 indication
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
| Arm | Type | Description |
|---|---|---|
| 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 |
| Name | Type | Description |
|---|---|---|
| Aflibercept | BIOLOGICAL | Intravitreal injection |
| OPT-302 | BIOLOGICAL | Intravitreal Injection |
| Sham intravitreal injection | OTHER | Sham (mock) intravitreal injection |
Inclusion Criteria: * History of diabetic macular edema (DME) ≤ 2 year * Persistent DME despite prior intravitreal anti-VEGF-A therapy with a sub-optimal response * Three or more prior anti-VEGF-A therapy intravitreal injections * EDTRS BCVA score ≤ 73 and ≥ 24 letters Exclusion Criteria: * Ocula...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| EyePoint, Inc. | EYPT | 2 | PHASE3 | EYP-1901, Aflibercept |
| Regeneron Pharmaceuticals, Inc. | REGN | 1 | PHASE3 | Aflibercept |
| Oculis Holding AG | OCS | 2 | PHASE3 | Dexamethasone, Vehicle |
| AbbVie, Inc. | ABBV | 3 | PHASE2 | ABBV-RGX-314 Dose 1, Steroid, Aflibercept |
| Outlook Therapeutics, Inc. | OTLK | 1 | PHASE3 | bevacizumab |
| 4D Molecular Therapeutics, Inc. | FDMT | 1 | PHASE2 | 4D-150 IVT, Aflibercept IVT |
| Alvotech | ALVO | 1 | PHASE3 | AVT29, Eylea HD |
| Kiora Pharmaceuticals, Inc. | KPRX | 1 | PHASE2 | KIO-104 |
| REGENXBIO, Inc. | RGNX | 1 | PHASE2 | RGX-314 Dose 1, RGX-314 Dose 2, Aflibercept |
| Ocugen Inc | OCGN | 1 | PHASE1 | OCU200 |
| Adverum Biotechnologies, Inc. | ADVM | 1 | - | ADVM-022 |
Aflibercept is being studied for use in Diabetic Macular Edema, a condition that causes vision loss due to fluid buildup in the macula. It is administered as part of a combination therapy with OPT-302, another investigational drug. The treatment is currently in clinical development and is not yet approved for this indication.
Aflibercept is being developed by Opthea Limited, a biopharmaceutical company. Opthea is listed on the stock exchange under the ticker symbol OPT. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with Diabetic Macular Edema.
Aflibercept is currently in Phase 1 clinical development for Diabetic Macular Edema. A Phase 1 trial has been completed, and the drug is still investigational. It has not yet received FDA approval, and further clinical studies are needed to establish its safety and effectiveness.
Aflibercept has been studied in a completed Phase 1 clinical trial with the identifier NCT03397264. The trial was a dose-ranging study of OPT-302 combined with Aflibercept for persistent Diabetic Macular Edema. It enrolled 153 participants across the United States, Australia, Israel, and Latvia.
No, Aflibercept and OPT-302 are different drugs. Aflibercept is a monoclonal antibody being developed by Opthea Limited, while OPT-302 is a separate investigational agent. In the clinical trial, OPT-302 was given in combination with Aflibercept to treat Diabetic Macular Edema.