Aflivu and Ahzantive (aflibercept)
Aflivu and Ahzantive are approved for wet age-related macular degeneration, macular oedema secondary to central retinal vein occlusion and branch retinal vein occlusion, diabetic macular oedema, and myopic choroidal neovascularisation. Aflivu and Ahzantive contain the active ingredient aflibercept.
Ahzantive
Aflivu and Ahzantive are biosimilar medicines to the already approved reference product, Eylea. A biosimilar medicine is highly similar to an already approved product with no clinically meaningful differences in quality, effectiveness, or safety.
Aflivu and Ahzantive are used to treat adults with:
- neovascular (wet) age-related macular degeneration (wet AMD), a chronic eye disease that causes central vision loss
- visual impairment due to fluid buildup in the macula (macular oedema) secondary to blockage of the central retinal vein (central retinal vein occlusion or CRVO)
- visual impairment due to macular oedema secondary to blockage of the retinal vein branch (branch retinal vein occlusion or BRVO)
- diabetic macular oedema (DME), swelling of the retina in patients with diabetes due to fluid buildup in the macula
- visual impairment due to myopic choroidal neovascularisation (myopic CNV), a severe form of short sightedness (myopia).
Aflibercept, the active ingredient in Aflivu and Ahzantive, binds to vascular endothelial growth factor A (VEGF-A) and placental growth factor (PlGF), blocking their activity. These growth factors contribute to the progression of wet AMD, myopic CNV and macular oedema due to CRVO, BRVO or DME.
Aflivu and Ahzantive can stop the growth and leakage of abnormal blood vessels and swelling of the retina, which can help improve eyesight or stop it getting worse. Aflivu and Ahzantive can help stabilise and sometimes improve vision loss related to wet AMD, myopic CNV and macular oedema due to CRVO, BRVO or DME.
The effectiveness and safety of Aflivu and Ahzantive were assessed in one main clinical study.
The clinical study compared Aflivu and Ahzantive with the already approved reference product, Eylea.
Key findings from the clinical study
- Aflivu and Ahzantive were shown to be bioequivalent (works the same way in the body) to the reference product (Eylea).
- Safety findings were similar between Aflivu and Ahzantive and the reference product (Eylea).
- The most frequent side effects of Aflivu and Ahzantive were bloodshot eye, decreased sharpness of vision, eye pain, clouding of the lens (cataract), increase in eye pressure, detachment of the gel-like substance inside the eye from the retina (vitreous detachment), and moving spots in vision.
The TGA decided that the application provided sufficient evidence supporting the safety and effectiveness of Aflivu and Ahzantive and the medicine can be registered in Australia.
More detailed information on why the TGA approved Aflivu and Ahzantive will be published in the upcoming Australian Public Assessment Report (AusPAR).
For comprehensive information on potential side effects and risks, refer to the Consumer Medicine Information (CMI) leaflet or Product Information (PI) document.
This decision summary will not be updated to reflect any subsequent changes and may therefore not contain the most current information about the medicine. For the latest information, refer to the medicine’s CMI or PI.
The CMI leaflet offers guidance for consumers to support safe and effective use of the medicine. The CMI includes information on dose, how to use the medicine properly, potential side effects, safety precautions, storage instructions and more.
Australian CMIs can be accessed through the searchable TGA eBusiness Services or ARTG databases.
The PI document provides essential prescribing information for health professionals, including details on dosage recommendations, pregnancy category, contraindications, precautions and potential side effects.
Australian PIs can be accessed through the searchable TGA eBusiness Services or ARTG databases.
- AFLIVU aflibercept (rch) 40 mg/mL solution for intravitreal injection vial (489558)
- AFLIVU aflibercept (rch) 40 mg/mL solution for intravitreal injection pre-filled syringe (489559)
- AHZANTIVE aflibercept (rch) 40 mg/mL solution for intravitreal injection vial (489560)
- AHZANTIVE aflibercept (rch) 40 mg/mL solution for intravitreal injection pre-filled syringe (489561)
For health advice and information, including a symptom checker and service finder refer to the healthdirect website.
For information on medicines subsidised by the Australian Government refer to the Pharmaceutical Benefits Scheme (PBS) website.
For data and reports on health and welfare topics in Australia refer to the Australian Institute of Health and Welfare website.