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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, BAY86-5321
Aflibercept · 5 trials · 10 indications
Best Corrected Visual Acuity (BCVA) was measured in the study eye by the Early Treatment Diabetic Retinopathy Study (ETDRS) letter score starting at 4 meters. The ETDRS chart includes 70 letters in total and the letter score ranges from 0 to 100. More letters read correctly results in a higher letter score, which represents better visual acuity.
Visual function was assessed with the procedure from the ETDRS adapted for the Age Related Eye Disease Study using charts with 70 letters at a starting distance of 4 meters. Charts are organized in 14 lines of decreasing size with 5 letters each. Participants reading up to 19 letters at 4 meters were tested at 1 meter to read the first 6 lines. The score equals the sum of letters read at 1 meter and 4 meters. If more than 19 letters are read at 4 meters the score equals the number of letters read plus 30. The score range is 0 to 100, and a higher score represents better visual function.
Mean Central Macular Thickness (CMT) on Spectral Domain OCT (SDOCT) at 12 months
| Arm | Type | Description |
|---|---|---|
| Aflibercept 8 mg | EXPERIMENTAL | The first loading injection will be performed for all participants. After 4 weeks, treatment response will be judged. If the polyp is completely regressed with no disease activity, injection interval will be extended to 8 weeks. The participants with presence of disease activity will continue 4-week loading injections up to 3 monthly loading dose and commence the T\&E phase thereafter. In the T\&E phase, patients have their injection interval extended or shortened by 4 weeks. The injection interval is maintained if the criteria for treatment adjustment were not met and residual fluid was decreased from the previous visit. The minimum and maximum injection intervals are 8 and 24 weeks, respectively. |
| Aflibercept 2 mg fixed | EXPERIMENTAL | Participants received fixed dosing of 2 mg aflibercept at injection intervals of 8 weeks |
| Aflibercept 2 mg flexible | EXPERIMENTAL | Participants received flexible dosing of 2 mg aflibercept at injection intervals of ≥8 week |
| Aflibercept 2 mg PRN | EXPERIMENTAL | Participants received monthly monitoring with 2 mg aflibercept injection pro re nata (PRN, as needed) |
| Aflibercept extended dosing | EXPERIMENTAL | Aflibercept was administered 2mg per injection intravitreal (IVT) in the study eye in Aflibercept extended dosing. Flexible dosing interval is ≥ 8 weeks (no upper limit) based on visual and anatomic outcomes as judged by the investigator. When/if visual and anatomical outcomes indicated that the disease had re-activated, the treatment interval reverted to the last treatment interval in which the disease was inactive (ie, no signs of exudation were observed). |
| Aflibercept 2Q8 (2 mg aflibercept administered every 8 weeks) | ACTIVE_COMPARATOR | Aflibercept was administered 2mg per injection IVT in the study eye in Aflibercept 2Q8. Fixed dosing interval is 8 weeks (±3 days), modification of the treatment interval was not allowed. |
| Aflibercept | EXPERIMENTAL | Patients will receive 2 mg of aflibercept by intravitreal injection every 4 weeks until week 8, followed by every 6 weeks to week 26 |
| Aflibercept (Eylea) | EXPERIMENTAL | All patients recruited to the study will receive 3 loading intravitreal injections of Aflibercept (Eylea) at monthly intervals followed by a treat and extend protocol up to 12 months. Extension from monthly to 6, 8, 10 and 12 week follow-up will occur when there is evidence of OCT stability in the view of the investigator i.e. there is no further reduction in macular fluid compared to the previous visit. All patients will receive 5 injections before considering them non-responders. |
| Name | Type | Description |
|---|---|---|
| aflibercept 8 mg | DRUG | The first loading injection will be performed for all participants. After 4 weeks, treatment response will be judged. If the polyp is completely regressed with no disease activity, injection interval will be extended to 8 weeks. The participants with presence of disease activity will continue 4-week loading injections up to 3 monthly loading dose and commence the T\&E phase thereafter. In the T\&E phase, patients have their injection interval extended or shortened by 4 weeks. The injection interval is maintained if the criteria for treatment adjustment were not met and residual fluid was decreased from the previous visit. The minimum and maximum injection intervals are 8 and 24 weeks, respectively. |
| Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321) | DRUG | - |
| Aflibercept | DRUG | Intravitreal Injection |
Inclusion Criteria: 1. Signed informed consent must be obtained prior to participation in the study. 2. Male or female patients ≥ 19 years of age at screening 3. Presence of active polypoidal lesions in the macular as shown by ICGA and presence of serosanguinous maculopathy (exudative or hemorrhagi...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| AbbVie, Inc. | ABBV | 7 | PHASE3 | Surabgene Lomparvovec, RGX-314, ABBV-6628 |
| Ocular Therapeutix Inc | OCUL | 3 | PHASE3 | OTX-TKI |
| 4D Molecular Therapeutics, Inc. | FDMT | 3 | PHASE3 | 4D-150 |
| Regeneron Pharmaceuticals, Inc. | REGN | 2 | PHASE3 | Aflibercept, Pozelimab, Cemdisiran |
| Novartis AG Sponsored ADR | NVS | 5 | PHASE2 | Iptacopan, GT005, FWY003 |
| EyePoint, Inc. | EYPT | 2 | PHASE3 | EYP-1901 |
| Kodiak Sciences, Inc. | KOD | 1 | PHASE3 | Tarcocimab tedromer, Tabirafusp tedromer |
| Hoffmann-La Roche | RHHBY | 10 | PHASE3 | Ranibizumab, Susvimo, RO7965032, OpRegen, Faricimab |
| Outlook Therapeutics, Inc. | OTLK | 1 | PHASE3 | ONS-5010 |
| Adverum Biotechnologies, Inc. | ADVM | 4 | PHASE3 | Ixo-vec, ADVM-022 |
| Apellis Pharmaceuticals, Inc. | APLS | 1 | PHASE2 | APL-3007 |
| Amgen Inc. | AMGN | 1 | PHASE3 | ABP 938, Aflibercept |
| Johnson & Johnson | JNJ | 1 | PHASE2 | JNJ-81201887 |
| Ocugen Inc | OCGN | 1 | PHASE3 | OCU410 |
| Alcon AG | ALC | 1 | PHASE1 | AR-14034 |
| Sanofi SA Sponsored ADR | SNY | 1 | PHASE1 | SAR402663 |
| Arrowhead Pharmaceuticals, Inc. | ARWR | 1 | PHASE1 | ARO-033 |
| Bayer | BAYRY | 2 | - | Aflibercept |
Aflibercept is used in ophthalmology to treat retinal conditions including macular degeneration, macular edema, macular oedema, and polypoidal choroidal vasculopathy. It is being studied in Phase 3 clinical trials for these indications. Bayer AG, trading as BAYRY, is the developer.
Aflibercept targets PGF and VEGFA. It is an inhibitor of these targets, which are involved in blood vessel growth and leakage in the eye. By inhibiting PGF and VEGFA, aflibercept works to reduce vascular permeability and abnormal angiogenesis associated with retinal diseases.
Aflibercept is developed by Bayer AG, which trades under the ticker BAYRY. Bayer AG is a global pharmaceutical and life sciences company. The drug is being investigated in multiple clinical trials for ophthalmic indications.
Aflibercept is in Phase 3 clinical development. It is investigational and has not been approved by the FDA for the indications described here. The Phase 3 program includes trials in polypoidal choroidal vasculopathy and diabetic macular edema, among others.
Aflibercept is being studied in several clinical trials. The PALLAS trial (NCT07389980) is a recruiting Phase 3 study in treatment-naive polypoidal choroidal vasculopathy. Completed trials include NCT02818998 in diabetic macular edema, NCT02661711 in macular oedema with retinitis pigmentosa, and NCT02540954 in neovascular age-related macular degeneration.
Yes, Aflibercept is also known as Eylea, VEGF Trap-Eye, BAY86-5321, and aflibercept 8 mg. These are alternative names for the same drug. Eylea is a brand name, while VEGF Trap-Eye and BAY86-5321 are developmental or chemical designations.