Last reviewed · How we verify
Eylea HD (aflibercept HD)
Eylea HD (aflibercept HD) is a VEGF inhibitor / Antiangiogenic agent Small molecule drug developed by Alvotech Swiss AG. It is currently in Phase 3 development for Neovascular (wet) age-related macular degeneration, Diabetic macular edema, Retinal vein occlusion.
Eylea HD is a high-dose formulation of aflibercept, a VEGF trap that binds and inhibits vascular endothelial growth factor to reduce abnormal blood vessel growth and leakage in the eye.
Eylea HD is a high-dose formulation of aflibercept, a VEGF trap that binds and inhibits vascular endothelial growth factor to reduce abnormal blood vessel growth and leakage in the eye. Used for Neovascular (wet) age-related macular degeneration, Diabetic macular edema, Retinal vein occlusion.
-
Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Eylea HD (aflibercept HD) |
|---|---|
| Sponsor | Alvotech Swiss AG |
| Drug class | VEGF inhibitor / Antiangiogenic agent |
| Target | VEGF-A, PlGF (Placental Growth Factor) |
| Modality | Small molecule |
| Therapeutic area | Ophthalmology |
| Phase | Phase 3 |
Mechanism of action
Aflibercept is a recombinant fusion protein that acts as a soluble decoy receptor for VEGF-A and PlGF, preventing these growth factors from binding to their endogenous receptors on vascular endothelial cells. By sequestering VEGF, it reduces pathological neovascularization and vascular permeability in retinal diseases. The HD (high-dose) formulation allows for less frequent dosing while maintaining therapeutic efficacy.
Approved indications
- Neovascular (wet) age-related macular degeneration
- Diabetic macular edema
- Retinal vein occlusion
- Myopic choroidal neovascularization
Common side effects
- Conjunctival hemorrhage
- Eye pain
- Floaters
- Intraocular pressure elevation
- Endophthalmitis
Key clinical trials
- Clinical Study to Compare Efficacy and Safety of AVT29 and Eylea HD in Participants With Diabetic Macular Edema (PHASE3)
- High Dose Eylea for Proliferative Diabetic Retinopathy Outcomes (PHASE4)
- Comparative Multicenter Randomized Study of Aflibercept Versus Placebo in Macular Telangiectasia Type 1 (PHASE3)
- A Study to Learn More About How Well 8 Milligram Aflibercept Works and How Safe it is in Chinese Participants With Diabetic Macular Edema (PHASE3)
- A Study to Learn About the Blood Levels of Aflibercept When High-dose Aflibercept is Injected in Both Eyes of Participants With Diabetic Macular Edema or Neovascular Age-related Macular Degeneration (PHASE4)
- A Phase 3b, Single-Arm Study of Aflibercept 8 mg Dosed Every 4 Weeks in Adult Participants With Neovascular Age-Related Macular Degeneration (nAMD) or Diabetic Macular Edema (DME) (PHASE3)
- Study of the Effects of High Dose Aflibercept Injected Into the Eye of Patients With an Age-related Disorder That Causes Loss of Vision Due to Growth of Abnormal Blood Vessels at the Back of the Eye (PHASE3)
- High Dose (HD) Aflibercept Switch in Neovascular Age-related Macular Degeneration (nAMD): to Load or Maintain (HEIRLOOM) (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Eylea HD (aflibercept HD) CI brief — competitive landscape report
- Eylea HD (aflibercept HD) updates RSS · CI watch RSS
- Alvotech Swiss AG portfolio CI
Frequently asked questions about Eylea HD (aflibercept HD)
What is Eylea HD (aflibercept HD)?
How does Eylea HD (aflibercept HD) work?
What is Eylea HD (aflibercept HD) used for?
Who makes Eylea HD (aflibercept HD)?
What drug class is Eylea HD (aflibercept HD) in?
What development phase is Eylea HD (aflibercept HD) in?
What are the side effects of Eylea HD (aflibercept HD)?
What does Eylea HD (aflibercept HD) target?
Related
- Drug class: All VEGF inhibitor / Antiangiogenic agent drugs
- Target: All drugs targeting VEGF-A, PlGF (Placental Growth Factor)
- Manufacturer: Alvotech Swiss AG — full pipeline
- Therapeutic area: All drugs in Ophthalmology
- Indication: Drugs for Neovascular (wet) age-related macular degeneration
- Indication: Drugs for Diabetic macular edema
- Indication: Drugs for Retinal vein occlusion
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing