EYLEA

What it is

EYLEA is aflibercept (rch) solution for intravitreal injection. 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. Aflibercept is produced in Chinese hamster ovary (CHO) K1 cells by recombinant DNA technology. EYLEA is available in two strengths: 40 mg/mL for 2 mg dosing and 114.3 mg/mL for 8 mg dosing. The 40 mg/mL formulation is a sterile, clear, colourless to pale yellow, preservative-free, iso-osmotic aqueous solution. The 114.3 mg/mL formulation is a sterile, clear to slightly opalescent, colourless to pale yellow, preservative-free, iso-osmotic aqueous solution.

Approved indications EYLEA 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) EYLEA 8 mg is indicated in adults for the treatment of: — neovascular (wet) age-related macular degeneration (wet AMD) — diabetic macular oedema (DME)

Dosing overview

EYLEA is for intravitreal injection only and must only be administered by a qualified ophthalmologist experienced in administering intravitreal injections. Once optimal visual acuity is achieved and/or there are no signs of disease activity, treatment may be continued with a treat-and-extend regimen with gradually increased treatment intervals. If disease activity persists or recurs, the treatment interval may be shortened accordingly.

Key safety warnings

Intravitreal injections, including those with EYLEA, 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 EYLEA. Patients should be instructed to report any symptoms suggestive of endophthalmitis, retinal vasculitis or retinal occlusive vasculitis without delay and should be managed appropriately. Transient increases in intraocular pressure have been seen within 60 minutes of an intravitreal injection, including with EYLEA. 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 following intravitreal use of VEGF inhibitors. Arterial thromboembolic 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. Risk factors associated with the development of a retinal pigment epithelial tear after anti-VEGF therapy for wet AMD include a large and/or high pigment epithelial retinal detachment. When initiating anti-VEGF therapy, caution should be used in patients with these risk factors for retinal pigment epithelial tears.

Contraindications

Known hypersensitivity to aflibercept or to any of the excipients; ocular or periocular infection; and active severe intraocular inflammation.

PBS listing

EYLEA is listed on the PBS in four formulations: solution for intravitreal injection 3.6 mg in 90 microlitres (40 mg per mL) pre-filled syringe with eight PBS items (streamlined and authority required restriction, ex-manufacturer price A$269.54); solution for intravitreal injection 4 mg in 100 microlitres (40 mg per mL) with eight PBS items (authority required and streamlined restriction, ex-manufacturer price A$271.36); solution for intravitreal injection 11.43 mg in 100 microlitres (114.3 mg per mL) with four PBS items (authority required and streamlined restriction, ex-manufacturer price A$396.69); and solution for intravitreal injection 11.43 mg in 100 microlitres (114.3 mg per mL) pre-filled syringe with four PBS items (streamlined and authority required restriction, ex-manufacturer price A$382.58).

Regulatory history

EYLEA aflibercept 40 mg/mL solution for intravitreal injection vial and pre-filled syringe were first listed on the ARTG on 7 March 2012. The 114.3 mg/mL vial was first listed on 14 June 2024 and the 114.3 mg/mL pre-filled syringe with OcuClick dosing system was first listed on 8 October 2024. In November 2014, the PBAC recommended a change to the PBS listing for neovascular (wet) age-related macular degeneration to allow treatment of patients with bilateral disease. The same month, the PBAC recommended EYLEA for the treatment of macular oedema secondary to retinal vein occlusion. In November 2015, the PBAC recommended extending the listing for macular oedema secondary to branch retinal vein occlusion on a cost-minimisation basis with ranibizumab. In November 2017, the PBAC recommended an amendment to allow aflibercept to be used for the treatment of diabetic macular oedema in patients with best corrected visual acuity of 6/12 or less. That same month, the PBAC recommended a new listing for treatment of visual impairment due to myopic choroidal neovascularisation. In May 2024, the PBAC recommended authority required listings for aflibercept 8 mg for diabetic macular oedema and subfoveal choroidal neovascularisation secondary to nAMD, based on cost-effectiveness if cost-minimised to the lowest cost PBS-listed anti-VEGF treatment. In November 2024, the PBAC recommended authority required listings of the 8 mg pre-filled syringe for both diabetic macular oedema and subfoveal choroidal neovascularisation secondary to AMD, cost-minimised to the lowest cost PBS-listed anti-VEGF treatment.