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Also known as Aflibercept High Dose VEGF Trap-Eye (BAY86-5321)
Aflibercept High Dose VEGF Trap-Eye · 1 trial · 1 indication
Visual function of the study eye was assessed at a distance of 4 meters using the ETDRS BCVA letter score. BCVA scale range is 0 (worst) to 100 (best).
| Arm | Type | Description |
|---|---|---|
| Aflibercept 2q8 | ACTIVE_COMPARATOR | In the double-masked study part (Years 1 and 2), Aflibercept 2 mg administered every 8 weeks after a loading phase. (Active Comparator) In Year 3, high dose aflibercept administered according to individual patient response. (Experimental) |
| Aflibercept HDq12 | EXPERIMENTAL | Aflibercept high dose (HD) administered every 12 weeks after an initiation phase. Treatment intervals adjusted according to individual patient response. |
| Aflibercept HDq16 | EXPERIMENTAL | Aflibercept high dose administered every 16 weeks after an initiation phase. Treatment intervals adjusted according to individual patient response. |
| Name | Type | Description |
|---|---|---|
| Aflibercept High Dose VEGF Trap-Eye (BAY86-5321) | DRUG | Solution in Vial, intravitreal (IVT) injection |
| Aflibercept VEGF Trap-Eye (Eylea, BAY86-5321) | DRUG | Solution in Vial, 2 mg, intravitreal (IVT) injection |
Inclusion Criteria: * Active subfoveal CNV secondary to nAMD, including juxtafoveal lesions that affect the fovea as assessed in the study eye. * Total area of CNV (including both classic and occult components) must comprise greater than 50% of the total lesion area in the study eye. * BCVA ETDRS l...
Aflibercept High Dose VEGF Trap-Eye is an investigational ophthalmic therapy developed by Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) for neovascular age-related macular degeneration, a condition in which abnormal blood vessels grow at the back of the eye and cause vision loss. It is a high dose formulation studied as an intravitreal injection.
It is being studied for the treatment of neovascular age-related macular degeneration, an age-related disorder that causes loss of vision due to growth of abnormal blood vessels at the back of the eye. The Phase 3 trial enrolled patients 50 years of age and older with this condition.
Aflibercept High Dose VEGF Trap-Eye targets PGF and VEGFA. It acts as an inhibitor of these targets, which are proteins involved in the growth of abnormal blood vessels. By binding these targets, the therapy is designed to counteract the vascular growth underlying neovascular age-related macular degeneration.
Regeneron Pharmaceuticals, Inc., which trades under the ticker REGN, is the developer of Aflibercept High Dose VEGF Trap-Eye. The company is studying the high dose formulation in a Phase 3 clinical program for neovascular age-related macular degeneration.
Aflibercept High Dose VEGF Trap-Eye is in Phase 3 development. It is investigational and has not been approved. The program includes one completed Phase 3 trial, and the drug has received a Priority Review designation from the FDA.
Aflibercept High Dose VEGF Trap-Eye has been evaluated in the Phase 3 trial NCT04423718, titled a study of the effects of high dose aflibercept injected into the eye of patients with an age-related disorder that causes loss of vision due to growth of abnormal blood vessels at the back of the eye. The trial completed with 1,011 patients enrolled.
Yes. Aflibercept High Dose VEGF Trap-Eye is also known as BAY86-5321, so the two names refer to the same investigational compound. It is a high dose VEGF Trap-Eye formulation developed by Regeneron Pharmaceuticals, Inc. for neovascular age-related macular degeneration.