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Label indication EYLEA is indicated for the treatment of: EYLEA is a vascular endothelial growth factor (VEGF) inhibitor indicated for the treatment of patients with: Neovascular (Wet) Age-Related Macular Degeneration (AMD) ( 1.1 ) Macular Edema Following Retinal Vein Occlusion (RVO) ( 1.2 ) Diabetic Macular Edema (DME) ( 1.3 ) Diabetic Retinopathy (DR) ( 1.4 ) Retinopathy of Prematurity (ROP) ( 1.5 ) 1.1 Neovascular (Wet)… FDA label
Also known as EYLEA, VEGF Trap-Eye
Aflibercept monthly · 7 trials · 7 indications
Visual function of the study eye was assessed using the ETDRS protocol. A higher score represents better functioning.
Defined study baseline range of ETDRS Best Corrected Visual Acuity letter score of 73 to 35 letters (ETDRS equivalent of 20/40 to 20/200) in the study eye; a higher score represents better functioning.
Percentage values indicate the number of subjects in each arm who were able to read an additional 15 letters or more at Week 24 compared to baseline. Defined study baseline range of ETDRS Best Corrected Visual Acuity letter score of 73 to 24 letters (= Acuity of 20/40 to 20/320) in the study eye; a higher score represents better functioning.
Number of participants with AEs summarized by category
| Arm | Type | Description |
|---|---|---|
| VTE 2Q4 first, then VTE 2Q8 | EXPERIMENTAL | VEGF Trap-Eye \[BAY86-5321; EYLEA (aflibercept) Injection\] 2 mg Q4 (VTE 2Q4) administered every 4 weeks from Week 0 to Week 16, followed by every 8 weeks until Week 48 (2Q8) |
| Intravitreal Aflibercept Injection 2Q4 | EXPERIMENTAL | Participants received 2mg Intravitreal aflibercept injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) every 4 weeks (2Q4). |
| Intravitreal Aflibercept Injection 2Q8 | EXPERIMENTAL | Participants received 2mg Intravitreal aflibercept injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) every 4 weeks for 5 visits followed by injections every 8 weeks (2Q8). |
| Macular Laser Photocoagulation (Control) | ACTIVE_COMPARATOR | Participants received laser treatment at baseline and as needed at visits at which laser retreatment criteria were met, but no more frequently than every 12 weeks. |
| Arm 1 | EXPERIMENTAL | - |
| Arm 2 | SHAM_COMPARATOR | - |
| VEGF Trap-Eye | EXPERIMENTAL | Monthly IVT injection of VEGF Trap-Eye 2.0 mg until Week 24 Primary Endpoint |
| Sham | SHAM_COMPARATOR | Monthly Sham IVT injection until Week 24 Primary Endpoint |
| Intravitreal Aflibercept Injection (EYLEA, VEGF Trap-Eye) | EXPERIMENTAL | - |
| aflibercept every 2 months | EXPERIMENTAL | - |
| aflibercept monthly | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| VEGF Trap-Eye (BAY86-5321) | BIOLOGICAL | Subjects in the VEGF Trap-Eye group will receive intravitreal injections every 8 weeks following a loading phase with injections given every 4 weeks. The overall treatment period is 48 weeks. |
| Macular Laser Photocoagulation (Control) | PROCEDURE | Participants received laser treatment at baseline and as needed at visits at which laser retreatment criteria were met, but no more frequently than every 12 weeks. |
| No Drug | PROCEDURE | Sham procedure NOT involving injection of any substance; patient´s eye is anesthetized and a syringe without needle gently pressed on the cornea |
| VEGF Trap-Eye 2.0mg | BIOLOGICAL | Monthly intravitreal injection out to the Week 24 Primary endpoint |
| Sham | DRUG | Monthly sham intravitreal injection out to Week 24 Primary Endpoint |
| VEGF Trap Eye | DRUG | Intravitreal injection |
| Aflibercept every 2 months | DRUG | 2.0 mg aflibercept intravitreal injections once per month for the first 3 months (M0, M1, M2), then every 2 months (M4, M6, M8, M10) |
| Aflibercept monthly | DRUG | 2.0mg aflibercept intravitreal injections every month (M0-11) |
| VEGF Trap-Eye | DRUG | single IVT injection of 4.0 mg of VEGF Trap-Eye into the study eye on Day 1 |
Inclusion Criteria: * Adults ≥ 18 years with type 1 or 2 diabetes mellitus * Subjects with DME (diabetic macular edema) secondary to diabetes mellitus involving the center of the macula in the study eye * BCVA (best-corrected visual acuity) ETDRS (Early Treatment Diabetic Retinopathy Study) letter ...
Aflibercept monthly is being studied for radiation retinopathy, a condition that can damage the retina after radiation therapy. The Phase 1 trial also enrolled patients with macular edema. It is an investigational use of the drug and is not an approved treatment for this indication.
Aflibercept monthly targets PGF and VEGFA, two proteins that promote blood vessel growth and leakage. It acts as an inhibitor of these targets. By binding them, the drug is designed to reduce the abnormal vascular activity associated with radiation retinopathy.
Aflibercept monthly is developed by Regeneron Pharmaceuticals, Inc., which trades on Nasdaq under the ticker REGN. Regeneron is the sponsor behind the clinical program evaluating this agent in ophthalmology.
Aflibercept monthly is in Phase 1 development. The program has completed one Phase 1 trial in radiation retinopathy and macular edema. It is investigational and has not been approved by the FDA for this use.
Aflibercept monthly has been evaluated in the Phase 1 trial NCT01579760, titled Intravitreal Aflibercept Injection for Radiation Retinopathy. The trial was completed, enrolled 9 participants, was randomized and controlled, and was conducted in the United States.
Aflibercept monthly refers to a monthly dosing schedule of aflibercept, the active ingredient also marketed as Eylea. The Phase 1 radiation retinopathy study used intravitreal aflibercept injections. The monthly regimen is distinct from other approved dosing intervals for the same molecule.