Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
700 μg Dexamethasone · 3 trials · 2 indications
BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. The numbers of patients with at least a 15 or more letter improvement in BCVA in the study eye are presented.
The cumulative response rate of 15 or more letter improvement was based on the Kaplan-Meier estimate. A Kaplan-Meier analysis takes into account patients who dropped out from the study prior to achieving the 15 letter improvement. Values ranged from 0-1, with a higher number indicating a higher probability of response.
| Arm | Type | Description |
|---|---|---|
| 700 μg Dexamethasone | EXPERIMENTAL | 700 μg Dexamethasone intravitreal injection in the study eye on Day 1. |
| Sham | SHAM_COMPARATOR | Sham administered in the study eye on Day 1. |
| 700 µg Dexamethasone | EXPERIMENTAL | 700 µg dexamethasone intravitreal implant administered on Day 0 and Day 180. |
| 350 µg Dexamethasone followed by 700 µg Dexamethasone | EXPERIMENTAL | 350 µg dexamethasone intravitreal implant administered on Day 0 and 700 µg dexamethasone intravitreal implant on Day 180. |
| Sham Injection followed by 700 µg Dexamethasone | SHAM_COMPARATOR | Sham injection on Day 0 and 700 µg dexamethasone intravitreal implant on Day 180. |
| Name | Type | Description |
|---|---|---|
| 700 μg Dexamethasone | DRUG | 700 μg Dexamethasone intravitreal injection in the study eye on Day 1. |
| Sham | OTHER | Sham administered in the study eye on Day 1. |
| 700 µg Dexamethasone | DRUG | 700 µg dexamethasone intravitreal implant administered on Day 0 and/or Day 180. |
| 350 µg Dexamethasone | DRUG | 350 µg Dexamethasone intravitreal implant administered on Day 0. |
| Sham Injection | OTHER | Sham injection on Day 0. |
Inclusion Criteria: -Presence of macular edema defined as macular thickening involving the center of the macula due to branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO) Exclusion Criteria: * History of glaucoma, ocular hypertension or optic nerve head change * Any acti...
| 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 |
700 μg Dexamethasone is an investigational small molecule being developed for the treatment of macular edema, specifically macular edema resulting from retinal vein occlusion. It is administered as a 700 microgram dose and is currently in Phase 3 clinical development.
700 μg Dexamethasone is a corticosteroid that works by reducing inflammation and vascular permeability in the eye, which helps to decrease fluid accumulation in the macula. This mechanism addresses the underlying pathology of macular edema associated with retinal vein occlusion.
700 μg Dexamethasone is being developed by AbbVie Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol ABBV. The company is conducting Phase 3 clinical trials to evaluate the drug's safety and efficacy.
700 μg Dexamethasone is in Phase 3 clinical development. It is an investigational drug and has not yet been approved by regulatory authorities. Three Phase 3 trials have been completed, with a total of 1,529 patients enrolled across multiple countries.
700 μg Dexamethasone has been studied in three completed Phase 3 trials: NCT00168298 with 668 patients, NCT00168324 with 599 patients, and NCT01660802 with 262 patients. All trials evaluated the drug for macular edema resulting from retinal vein occlusion.
700 μg Dexamethasone is a specific dose formulation of dexamethasone, a corticosteroid. The drug is being studied at a 700 microgram dose for the treatment of macular edema. It is distinct from other dexamethasone formulations due to its specific dosage and delivery method.