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Also known as AGN208397 intravitreal injection
AGN208397 intravitreal · 1 trial · 2 indications
Retinal thickness is assessed by optical coherence tomography (OCT) in the study eye. The retina is the light-sensitive part of the eye. OCT is a laser-based, noninvasive, diagnostic system providing high-resolution, three-dimensional images of the retina. A negative change from baseline indicates an improvement.
Retinal thickness is assessed by OCT in the study eye. The retina is the light-sensitive part of the eye. OCT is a laser-based, noninvasive, diagnostic system providing high-resolution, three-dimensional images of the retina. A negative change from baseline indicates an improvement.
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.
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.
| Arm | Type | Description |
|---|---|---|
| Stage 1 Cohort 1 | EXPERIMENTAL | AGN208397 intravitreal injection 75 ug on Day 1. |
| Stage 1 Cohort 2 | EXPERIMENTAL | AGN208397 intravitreal injection 300 ug on Day 1. |
| Stage 1 Cohort 3 | EXPERIMENTAL | AGN208397 intravitreal injection 600 ug on Day 1. |
| Stage 1 Cohort 4 | EXPERIMENTAL | AGN208397 intravitreal injection 900 ug on Day 1. |
| Stage 2 Arm 1 | EXPERIMENTAL | AGN208397 intravitreal injection 600 ug on Day 1. |
| Stage 2 Arm 2 | EXPERIMENTAL | AGN208397 intravitreal injection 450 ug on Day 1. |
| Stage 2 Arm 3 | EXPERIMENTAL | AGN208397 intravitreal injection 300 ug on Day 1. |
| Stage 2 Arm 4 | ACTIVE_COMPARATOR | Dexamethasone 700 ug intravitreal implant on Day 1. |
| Name | Type | Description |
|---|---|---|
| AGN208397 intravitreal injection | DRUG | AGN208397 intravitreal injection on Day 1. |
| dexamethasone intravitreal implant | DRUG | Dexamethasone 700 ug intravitreal implant on Day 1. |
Inclusion Criteria: * macular edema due to retinal vein occlusion * visual acuity in the study eye between 20/320 to 20/40 Exclusion Criteria: * cataract surgery or Lasik within 3 months prior to study Day 1 or anticipated need for cataract surgery during study period (12 months) * use of injecta...
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 |
AGN208397 intravitreal is being studied for the treatment of macular edema associated with retinal vein occlusion. It is an investigational small molecule administered by intravitreal injection into the eye. The clinical program evaluated it in adults with macular edema and retinal vein occlusion, a condition in which blocked retinal veins cause fluid buildup and swelling in the macula.
AGN208397 intravitreal is being developed by AbbVie Inc., which trades on the New York Stock Exchange under the ticker ABBV. AbbVie is the sponsor of the clinical program for this investigational ophthalmology asset.
AGN208397 intravitreal is in Phase 1 development. It is an investigational therapy and has not been approved by the FDA for any indication. The Phase 1 program has been completed, with one trial conducted and no active trials currently listed.
AGN208397 intravitreal was evaluated in one completed Phase 1 trial, NCT01027650, titled Safety and Efficacy of AGN208397 in the Treatment of Macular Edema Associated With Retinal Vein Occlusion. The trial enrolled 121 adults across the United States, Australia, Canada, Israel, and South Africa. It was randomized, double blind, and active controlled.
Yes, AGN208397 intravitreal and AGN208397 intravitreal injection refer to the same investigational therapy. The longer name describes the route of administration, an injection into the vitreous of the eye. Both names point to the same AbbVie small molecule being studied for macular edema associated with retinal vein occlusion.