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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 intravitreal anti-vascular endothelial growth factor, Eylea, intravitreal anti-VEGF
Prompt aflibercept · 2 trials · 2 indications
Best-corrected visual acuity following protocol-defined refraction. Visual Acuity was measured with the Electronic Early Treatment Diabetic Retinopathy Study (E-ETDRS) visual acuity test on a scale from 100 letters (Snellen equivalent of 20/12) to 0 letters (Snellen equivalent of 20/800).
CI-DME = center-involved diabetic macular edema, PDR = proliferative diabetic macular edema. First development of criteria meeting end point. Eyes that met any criteria are then censored from contributing to the next criteria. Eyes that did not meet the outcome were censored at the time of the last completed visit. Each outcome appears only once under "First PDR and/or DME criteria met." Outcomes appear under "Development of PDR" if PDR developed at any time in the study (regardless of if or when DME developed) and outcomes appear under "Development of DME" if DME developed at any time in the study (regardless of if or when PDR developed)
Visual acuity is measured as a continuous integer letter score from 0 to 100, with higher numbers indicating better visual acuity. A letter score of 85 is approximately 20/20 and a letter score of 70 is approximately 20/40, the legal unrestricted driving limit in most states. A 5-letter change for an individual is approximately equal to a 1-line change on a vision chart.
| Arm | Type | Description |
|---|---|---|
| Prompt Laser + Deferred Aflibercept | EXPERIMENTAL | Focal/grid laser followed by intravitreal aflibercept if vision worsens |
| Observation + Deferred Aflibercept | ACTIVE_COMPARATOR | No treatment to start followed by intravitreal aflibercept if vision worsens (deferred laser may be added to intravitreal aflibercept if certain criteria are met) |
| Prompt Aflibercept | EXPERIMENTAL | Intravitreal aflibercept at baseline and every 4 weeks as needed (deferred laser may be added to intravitreal aflibercept if certain criteria are met) |
| Observation (Prompt Sham) | SHAM_COMPARATOR | Sham injection in study eye at randomization and at visits at 1, 2, and 4 months and then every 4 months thereafter. Deferred aflibercept may be given if center-involved diabetic macular edema or proliferative diabetic retinopathy develops and deferred laser may subsequently be added to intravitreal aflibercept if certain criteria are met. |
| Name | Type | Description |
|---|---|---|
| Prompt Laser | PROCEDURE | Focal/grid laser performed at baseline and as needed during follow-up |
| Prompt aflibercept | DRUG | Intravitreal injection of 2.0mg aflibercept performed on the day of randomization and up to every 4 weeks using defined treatment criteria |
| Deferred laser | PROCEDURE | Focal/grid laser is initiated while receiving anti-VEGF injections only if certain criteria are met |
| Deferred aflibercept | DRUG | Intravitreal injection of 2.0mg aflibercept performed once certain criteria for vision loss are met and then up to every 4 weeks using defined treatment criteria |
| Prompt Sham | PROCEDURE | A sham injection (syringe without a needle pressed against the injection site) is performed on the day of randomization and visits at 1, 2, and 4 months and then every 4 months thereafter. |
Inclusion Criteria: 1. Age \>= 18 years 2. Diagnosis of diabetes mellitus (type 1 or type 2) Any one of the following will be considered to be sufficient evidence that diabetes is present: 1. Current regular use of insulin for the treatment of diabetes 2. Current regular use of oral anti-...
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 |
Prompt aflibercept is an investigational small molecule developed by Regeneron Pharmaceuticals, Inc. (ticker REGN) for ophthalmology indications. It is being studied in diabetic macular edema and diabetic retinopathy. It has received a PRIORITY_REVIEW designation from the FDA.
Prompt aflibercept is being developed for the treatment of diabetic macular edema and diabetic retinopathy. These are ophthalmology conditions involving retinal complications of diabetes. The clinical program has evaluated the drug in adults aged 18 years and older, including both male and female participants.
Prompt aflibercept targets INSR, the insulin receptor, and acts as an agonist at that target. This mechanism places it in the receptor agonist class. Its development focuses on ophthalmology indications, specifically diabetic macular edema and diabetic retinopathy.
Regeneron Pharmaceuticals, Inc., which trades under the ticker REGN, is the developer of Prompt aflibercept. The company is running the clinical program for the drug in ophthalmology, with studies conducted in the United States and Canada.
Prompt aflibercept is in Phase 3 clinical development. It is investigational and has not been approved by the FDA. One Phase 3 trial has been completed, and no trials are currently active. The program has enrolled a total of 702 participants across its studies.
Prompt aflibercept has been studied in completed Phase 3 trials, including NCT02634333, titled Anti-VEGF Treatment for Prevention of PDR/DME, which enrolled 399 participants, and NCT01909791, titled Treatment for CI-DME in Eyes With Very Good VA Study, which enrolled 702 participants. Both trials were active-controlled and conducted in the United States and Canada.