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Label indication OZURDEX is a corticosteroid indicated for: The treatment of macular edema following branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO) ( 1.1 ) The treatment of non-infectious uveitis affecting the posterior segment of the eye ( 1.2 ) The treatment of diabetic macular edema ( 1.3 ) 1.1 Retinal Vein Occlusion OZURDEX ® (dexamethasone intravitreal implant) is indicated for the treatment of… FDA label
Also known as Ozurdex®, Posurdex®
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...
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 |
700 μg Dexamethasone is an investigational small molecule developed for the treatment of macular edema, including macular edema following retinal vein occlusion. It is being studied in Phase 3 clinical trials. It is not described as approved, so it remains in clinical development for this ophthalmology indication.
700 μg Dexamethasone is being developed by AbbVie Inc., which trades under the ticker ABBV. AbbVie is the sponsor associated with the clinical development program for this ophthalmology asset.
700 μg Dexamethasone is in Phase 3 clinical development. Three Phase 3 trials have been completed, and there are currently no active trials listed. The program has enrolled a total of 1,529 participants across randomized, double-blind, sham-controlled studies.
Three completed Phase 3 trials have studied 700 μg Dexamethasone: NCT01660802 in China with 262 participants, NCT00168324 with 599 participants across multiple countries, and NCT00168298 with 668 participants across multiple countries. All three evaluated macular edema, with the latter two also enrolling patients with retinal vein occlusion.
The Phase 3 trials of 700 μg Dexamethasone were randomized, double-blind, and sham-controlled, enrolling adults 18 years and older of all sexes. The studies were conducted in patients with macular edema, including cases following retinal vein occlusion, and no biomarker selection was used.