ENZEEVU

What it is

ENZEEVU is aflibercept (recombinant), a recombinant fusion protein consisting of portions of human VEGF receptor 1 and 2 extracellular domains fused to the Fc portion of human IgG1. It is a solution for intravitreal injection. ENZEEVU is available in two strengths: 40 mg/mL for 2 mg dosing and 114.3 mg/mL for 8 mg dosing.

Approved indications ENZEEVU 2 mg is indicated in adults for the treatment of:

— Neovascular (wet) age-related macular degeneration (wet AMD). — Visual impairment due to macular oedema secondary to central retinal vein occlusion (CRVO). — Visual impairment due to macular oedema secondary to branch retinal vein occlusion (BRVO). — Diabetic macular oedema (DME). — Visual impairment due to myopic choroidal neovascularisation (myopic CNV). ENZEEVU 8 mg is indicated in adults for the treatment of neovascular (wet) age-related macular degeneration (wet AMD) and diabetic macular oedema (DME).

Dosing overview

ENZEEVU is for intravitreal injection only and must only be administered by a qualified ophthalmologist experienced in administering intravitreal injections. The interval between doses injected into the same eye should not be shorter than one month.

Key safety warnings

Intravitreal injections have been associated with endophthalmitis and more rarely with retinal vasculitis and/or retinal occlusive vasculitis. Proper aseptic injection technique must always be used when administering ENZEEVU. Patients should be instructed to report any symptoms suggestive of endophthalmitis, retinal vasculitis or retinal occlusive vasculitis without delay and should be managed appropriately. Intravitreal injections have been associated with retinal detachment. Transient increases in intraocular pressure have been seen within 60 minutes of an intravitreal injection. Special precaution is needed in patients with poorly controlled glaucoma. In all cases both the intraocular pressure and the perfusion of the optic nerve head must be monitored and managed appropriately. There is a potential risk of arterial thromboembolic events following intravitreal use of VEGF inhibitors. These events include vascular death, non-fatal strokes and non-fatal myocardial infarction. The risk of stroke may be greater in patients with known risk factors including a history of stroke or transient ischaemic attack. Patients should be carefully evaluated by their doctor to assess whether the benefits of treatment outweigh the potential risks.

Contraindications

ENZEEVU is contraindicated in known hypersensitivity to aflibercept or to any of the excipients, ocular or periocular infection, and active severe intraocular inflammation.

PBS listing

ENZEEVU aflibercept 40 mg/mL solution for intravitreal injection is registered on the ARTG. PBS listing information is not available in the provided sources.

Regulatory history

ENZEEVU was approved by the TGA as a new biosimilar entity to the reference product EYLEA (aflibercept) for the treatment of various ocular conditions, with the evaluation finding the biosimilar to be acceptable for the proposed indications. ARTG registration for ENZEEVU aflibercept 40 mg/mL solution for intravitreal injection was first listed on 2025-05-27.