EYDENZELT

What it is

EYDENZELT (aflibercept) is a biosimilar medicine to the reference product EYLEA (aflibercept) for 2 mg dosing. Aflibercept is 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 supplied as a solution for intravitreal injection. The solution is clear to slightly opalescent, colourless to very pale brownish yellow, preservative-free, iso-osmotic solution. The drug product is supplied as either a single-use pre-filled syringe or as a single-use vial.

Approved indications —

Visual impairment due to myopic choroidal neovascularisation (myopic CNV) in adults.

Dosing overview

The recommended dose for EYDENZELT is 2 mg aflibercept, equivalent to an injection volume of 50 μL. EYDENZELT 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. Treatment is initiated with one injection of 2 mg EYDENZELT. Additional doses should be administered only if visual and/or anatomic outcomes indicate that the disease persists. Recurrences are treated like a new manifestation of the disease.

Key safety warnings

Intravitreal injections, including those with aflibercept, 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 aflibercept. Intravitreal injections, including those with aflibercept, have been associated with retinal detachment. Transient increases in intraocular pressure have been seen within 60 minutes of an intravitreal injection, including with aflibercept. 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 therefore be monitored and managed appropriately. There is a potential risk of arterial thromboembolic events (ATEs) following intravitreal use of VEGF inhibitors. ATEs include vascular death (such as due to stroke or myocardial infarction), 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 (TIA).

Contraindications

Known hypersensitivity to aflibercept or to any of the excipients, ocular or periocular infection, and active severe intraocular inflammation are contraindications to EYDENZELT.

Regulatory history

The TGA's decision to approve this biosimilar medicine was made on 24 March 2025. EYDENZELT aflibercept (rch) 40 mg/mL solution for intravitreal injection was first listed on the ARTG on 31 March 2025 in two presentations: vial with needle (ARTG 431932) and pre-filled syringe (ARTG 431931).