Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as 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 ...
Top 16 of 17 competitors
| 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 |
Dexamethasone intravitreal is being studied for the treatment of macular edema, including diabetic macular edema. It is an investigational ophthalmology therapy given as an intravitreal implant. Development is at Phase 2, so it is not yet an approved treatment for this indication.
Dexamethasone intravitreal targets NR3C1, the glucocorticoid receptor, and acts as an agonist at that receptor. By activating NR3C1, dexamethasone delivers a corticosteroid effect directly into the eye, which is the basis for its evaluation in macular edema.
Dexamethasone intravitreal is developed by AbbVie Inc., which trades on the New York Stock Exchange under the ticker ABBV. AbbVie is the sponsor behind the clinical program evaluating this intravitreal implant in macular edema.
Dexamethasone intravitreal is in Phase 2 development for macular edema. It is an investigational small molecule implant and is not described as FDA approved for this use. The program has one completed Phase 2 trial, with no active trials currently listed.
Dexamethasone intravitreal has been studied in the completed Phase 2 trial NCT01492400, titled Safety and Efficacy Study of Dexamethasone Versus Ranibizumab in Patients With Diabetic Macular Edema. That randomized, active-controlled study enrolled 363 patients across the United States, Belgium, Denmark, France, Germany, Israel, Italy, the Netherlands, Portugal, South Africa, Spain, and the United Kingdom.
Yes. Dexamethasone intravitreal is also known as the dexamethasone intravitreal implant, and both names refer to the same therapy. It is a small molecule corticosteroid delivered as an intravitreal implant and is being developed by AbbVie for macular edema.