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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 treatment for neovascular age-related macular degeneration, a condition that causes vision loss due to abnormal blood vessel growth at the back of the eye. It is currently in Phase 3 clinical development and has not been approved by the FDA.
Aflibercept High Dose VEGF Trap-Eye targets vascular endothelial growth factor, or VEGF, which plays a key role in the abnormal blood vessel growth seen in neovascular age-related macular degeneration. By trapping VEGF, the drug aims to reduce this growth and the associated vision loss.
Aflibercept High Dose VEGF Trap-Eye is developed by Regeneron Pharmaceuticals, Inc., which trades on the Nasdaq under the ticker REGN. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with neovascular age-related macular degeneration.
Aflibercept High Dose VEGF Trap-Eye is in Phase 3 clinical development. It has received FDA priority review designation, but it remains investigational and is not yet approved for use. The drug is being studied in a completed Phase 3 trial with 1011 participants.
Aflibercept High Dose VEGF Trap-Eye has one completed Phase 3 trial, NCT04423718, which enrolled 1011 participants with neovascular age-related macular degeneration. The trial was randomized, double-blind, and active-controlled, and it took place across multiple countries including the United States, Japan, and Germany.
Aflibercept High Dose VEGF Trap-Eye is a high-dose formulation of aflibercept, the active ingredient in Eylea. While both target VEGF, the high-dose version is being studied specifically for neovascular age-related macular degeneration and is in Phase 3 development, whereas Eylea is already approved for multiple indications.