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Prompt aflibercept · 2 trials · 2 indications
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.
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).
| Arm | Type | Description |
|---|---|---|
| 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. |
| Prompt aflibercept | EXPERIMENTAL | Aflibercept injection in study eye at randomization and at visits at 1, 2, and 4 months and then every 4 months thereafter. More frequent 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. |
| 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) |
| Name | Type | Description |
|---|---|---|
| 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. |
| Prompt aflibercept | DRUG | Intravitreal injection of 2.0mg aflibercept is performed on the day of randomization and visits at 1, 2, and 4 months and then every 4 months thereafter. |
| Deferred laser | PROCEDURE | Laser (either focal/grid laser for diabetic macular edema or panretinal photocoagulation for proliferative diabetic retinopathy) is added following initiation of anti-vascular endothelial growth factor injections for center-involved diabetic macular edema or proliferative diabetic retinopathy only if certain criteria are met |
| Deferred aflibercept | DRUG | Intravitreal injection of 2.0mg aflibercept performed once proliferative diabetic retinopathy or center-involved diabetic macular edema develops and then up to every 4 weeks using defined treatment criteria. |
| Prompt Laser | PROCEDURE | Focal/grid laser performed at baseline and as needed during follow-up |
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 ant...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| EyePoint, Inc. | EYPT | 2 | PHASE3 | EYP-1901, Aflibercept |
| Regeneron Pharmaceuticals, Inc. | REGN | 1 | PHASE3 | Aflibercept |
| Oculis Holding AG | OCS | 2 | PHASE3 | Dexamethasone, Vehicle |
| AbbVie, Inc. | ABBV | 3 | PHASE2 | ABBV-RGX-314 Dose 1, Steroid, Aflibercept |
| Outlook Therapeutics, Inc. | OTLK | 1 | PHASE3 | bevacizumab |
| 4D Molecular Therapeutics, Inc. | FDMT | 1 | PHASE2 | 4D-150 IVT, Aflibercept IVT |
| Alvotech | ALVO | 1 | PHASE3 | AVT29, Eylea HD |
| Kiora Pharmaceuticals, Inc. | KPRX | 1 | PHASE2 | KIO-104 |
| REGENXBIO, Inc. | RGNX | 1 | PHASE2 | RGX-314 Dose 1, RGX-314 Dose 2, Aflibercept |
| Ocugen Inc | OCGN | 1 | PHASE1 | OCU200 |
| Adverum Biotechnologies, Inc. | ADVM | 1 | - | ADVM-022 |
Eylea (aflibercept) is an ophthalmology treatment for diabetic macular edema (DME) and diabetic retinopathy. It is a small molecule developed by Regeneron Pharmaceuticals. In clinical trials, it has been studied for treating center-involved DME in eyes with very good visual acuity and for preventing proliferative diabetic retinopathy or DME.
Eylea (aflibercept) is a vascular endothelial growth factor (VEGF) inhibitor. It works by binding to VEGF, a protein that promotes abnormal blood vessel growth and leakage in the eye, which are key drivers of diabetic macular edema and diabetic retinopathy. By neutralizing VEGF, Eylea helps reduce retinal swelling and prevent vision loss.
Eylea (aflibercept) is developed by Regeneron Pharmaceuticals, Inc., a biopharmaceutical company traded on NASDAQ under the ticker REGN. Regeneron is responsible for the clinical development and commercialization of Eylea for ophthalmology indications including diabetic macular edema and diabetic retinopathy.
Eylea (aflibercept) is in Phase 3 clinical development for diabetic macular edema and diabetic retinopathy. It has received FDA Priority Review designation. The drug is investigational and still in clinical development; it is not yet approved for these indications based on the available data.
Eylea (aflibercept) has been studied in two Phase 3 trials. NCT01909791, titled 'Treatment for CI-DME in Eyes With Very Good VA Study,' enrolled 702 participants with diabetic macular edema in the United States and Canada. NCT02634333, titled 'Anti-VEGF Treatment for Prevention of PDR/DME,' enrolled 399 participants with diabetic retinopathy and diabetic macular edema. Both trials are completed.
Yes, Eylea is the brand name for aflibercept, a small molecule developed by Regeneron Pharmaceuticals. In clinical trials and regulatory contexts, the drug is referred to as aflibercept, while Eylea is the commercial name used for the product in the market.