Approval Probability
TA Base Rate
Adjusted LOA
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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...
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 |
Aflibercept PFS is an 8 mg prefilled syringe formulation of aflibercept developed by Regeneron Pharmaceuticals, Inc. (ticker: REGN). It is being studied for delivery of aflibercept via a prefilled syringe in retinal conditions, including Diabetic Macular Edema (DME). It is an investigational product in Phase 3 development.
Aflibercept PFS is being evaluated for the treatment of Diabetic Macular Edema (DME). The Phase 3 study also enrolled patients with neovascular Age-Related Macular Degeneration (nAMD). It is an investigational 8 mg prefilled syringe formulation and is not described as approved for these uses.
Aflibercept PFS targets PGF and VEGFA. It is classified as an inhibitor of these targets, which are involved in vascular growth and leakage pathways relevant to retinal disease. This mechanism underlies its evaluation in Diabetic Macular Edema (DME) and neovascular Age-Related Macular Degeneration (nAMD).
Aflibercept PFS is being developed by Regeneron Pharmaceuticals, Inc., which trades under the ticker REGN. Regeneron is the sponsor of the Phase 3 study evaluating the 8 mg aflibercept prefilled syringe. The product is referred to as EYLEA in the trial title.
Aflibercept PFS is in Phase 3 development. One Phase 3 trial has been completed, and no active trials are currently listed. The program has a PRIORITY_REVIEW regulatory designation. It is an investigational product and is not described as FDA approved for Diabetic Macular Edema (DME).
Aflibercept PFS has been studied in one completed Phase 3 trial, NCT05989126, titled "Study to Evaluate an 8 mg Aflibercept (EYLEA) Prefilled Syringe (PFS)." The trial enrolled 35 participants in the United States and included patients with Diabetic Macular Edema (DME) and neovascular Age-Related Macular Degeneration (nAMD).