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aflibercept PFS · 1 trial · 2 indications
Participants received a single dose of study drug, administered in the selected study eye with the PFS by a retina specialist. Physician assessed successful aflibercept preparation and administration with the PFS.
| Arm | Type | Description |
|---|---|---|
| 8 mg Dose | EXPERIMENTAL | Only 1 eye will be selected as the study eye by the investigator. Patients will receive a single dose utilizing the PFS. |
| Name | Type | Description |
|---|---|---|
| aflibercept 8 mg PFS | DRUG | Sterile aqueous solution in a single-dose PFS administered by intravitreal (IVT) injection |
Key Inclusion Criteria: 1. Patient must have diabetic macular edema (DME) or neovascular "wet" age-related macular degeneration (nAMD) in the study eye 2. Study eye considered by the retina specialist to be eligible for treatment with 8 mg aflibercept Key Exclusion Criteria: 1. Any active intraoc...
| 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 |
Aflibercept PFS is an investigational 8 mg prefilled syringe formulation of aflibercept (EYLEA) being studied for the treatment of Diabetic Macular Edema (DME). It is also being evaluated in patients with Neovascular Age-Related Macular Degeneration (nAMD). The drug is administered in the ophthalmology therapeutic area.
Aflibercept PFS is being developed by Regeneron Pharmaceuticals, Inc., which trades on the NASDAQ under the ticker REGN. The company is conducting clinical trials to evaluate this prefilled syringe formulation of aflibercept for use in patients with diabetic macular edema and other retinal conditions.
Aflibercept PFS is currently in Phase 3 clinical development. It has received FDA Priority Review designation. The drug is investigational and has not been approved by the FDA, as it is still undergoing clinical evaluation for the treatment of Diabetic Macular Edema.
Aflibercept PFS is being studied in clinical trial NCT05989126, titled "Study to Evaluate an 8 mg Aflibercept (EYLEA®) Prefilled Syringe (PFS)". This Phase 3 trial has been completed and enrolled 35 participants in the United States with Diabetic Macular Edema and Neovascular Age-Related Macular Degeneration.
Aflibercept PFS is an 8 mg prefilled syringe formulation of aflibercept, which is the active ingredient in EYLEA. The prefilled syringe is designed to deliver the same medication in a ready-to-use format. It is being evaluated as a potential new presentation of the existing aflibercept product.