OPUVIZ

What it is

OPUVIZ is aflibercept (rch), 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.

Approved indications OPUVIZ 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)

Dosing overview

The recommended dose of OPUVIZ 40 mg/mL is 2 mg aflibercept, equivalent to an injection volume of 50 µL. The interval between doses injected into the same eye should not be shorter than one month. OPUVIZ must only be administered by a qualified ophthalmologist experienced in administering intravitreal injections. For wet AMD, treatment is initiated with one injection per month for three consecutive months, followed by one injection every two months. For macular oedema secondary to CRVO, treatment is initiated with one injection per month for three consecutive months, after which the treatment interval may be adjusted based on visual and/or anatomic outcomes. For macular oedema secondary to BRVO, treatment is initiated with one injection per month for three consecutive months, after which the treatment interval may be adjusted based on visual and/or anatomic outcomes. For DME, treatment is initiated with one injection per month for five consecutive months, following which the treatment interval may be maintained at an injection every two months or further individualised based on visual and/or anatomic outcomes. For myopic CNV, treatment is initiated with one injection, with additional doses administered only if visual and/or anatomic outcomes indicate that the disease persists.

Key safety warnings

Intravitreal injections, including those with OPUVIZ, 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 OPUVIZ. 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, including those with OPUVIZ, have been associated with retinal detachment. Transient increases in intraocular pressure have been seen within 60 minutes of an intravitreal injection, including with OPUVIZ. 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, 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). Patients should be carefully evaluated by their doctor to assess whether the benefits of treatment outweigh the potential risks.

Contraindications

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

PBS listing

No source document contains information about PBS listing for OPUVIZ.

Regulatory history

The TGA approved OPUVIZ for registration based on demonstrated biosimilarity to the reference product EYLEA, with comparable quality, nonclinical profiles, and equivalent clinical efficacy in neovascular AMD. The approval decision was made on 10 September 2025. OPUVIZ aflibercept 40 mg/mL solution for intravitreal injection in vial (ARTG 456527) and OPUVIZ aflibercept 40 mg/mL solution for intravitreal injection in vial with needle (ARTG 456528) were first listed on 18 September 2025 (licence category RE). Extensive quality and nonclinical studies demonstrated OPUVIZ's biosimilarity to EYLEA, with minor differences considered unlikely to impact clinical safety or efficacy. The Phase III clinical study SB15-3001 confirmed equivalence in efficacy, as measured by change from baseline in best corrected visual acuity at Week 8, for subjects with neovascular AMD.