Approval Probability
TA Base Rate
Adjusted LOA
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Also known as dexamethasone intravitreal implant, dexamethasone Intravitreal Implant
dexamethasone intravitreal · 1 trial · 1 indication
BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The average BCVA is calculated across study visits for each patient. A positive number change from baseline indicates an improvement and a negative number change from baseline indicates a worsening.
| Arm | Type | Description |
|---|---|---|
| dexamethasone Intravitreal Implant | EXPERIMENTAL | Injection of 700 ug dexamethasone intravitreal implant into the study eye on Day 1, Month 5, and Month 10. |
| ranibizumab | ACTIVE_COMPARATOR | Injection of ranibizumab 0.5 mg into the study eye on Day 1. Patients may receive additional injections on a monthly basis, as needed, for disease progression. |
| Name | Type | Description |
|---|---|---|
| dexamethasone Intravitreal Implant | DRUG | Injection of 700 ug dexamethasone intravitreal implant into the study eye on Day 1, Month 5, and Month 10. |
| ranibizumab | DRUG | Injection of ranibizumab 0.5 mg into the study eye on Day 1. Patients may receive additional injections on a monthly basis, as needed, for disease progression. |
Inclusion Criteria: * Diagnosis of type 1 or 2 diabetes mellitus * Diagnosis of macular edema * Visual acuity between 20/200 to 20/40 Exclusion Criteria: * Eye surgery to the study eye within 3 months * Use of Ozurdex® within 9 months * Any active ocular inflammation and infection * Diagnosis of ...
| 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 | 2 | 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 |