AFQLIR

What it is

AFQLIR is a biosimilar medicine to EYLEA (aflibercept) 2 mg. 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. AFQLIR is presented as a solution for intravitreal injection. AFQLIR 40 mg/mL is a sterile, clear, colourless to slightly brownish-yellow, preservative-free, iso-osmotic aqueous solution.

Approved indications AFQLIR 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 for AFQLIR (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. Specific dosing schedules vary by indication. For wet AMD, AFQLIR 2 mg treatment is initiated with one injection per month for three consecutive months, followed by one injection every two months, with the interval potentially extended further using a treat-and-extend dosing regimen. 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, followed by adjustments to every two months or individualised treatment intervals. For myopic choroidal neovascularisation, treatment is initiated with one injection, with additional doses administered only if visual and/or anatomic outcomes indicate disease persistence.

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 AFQLIR. Intravitreal injections, including those with aflibercept, have been associated with retinal detachment. 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, and 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 for immunogenicity as aflibercept is a therapeutic protein; patients should be instructed to report any signs or symptoms of intraocular inflammation such as pain, photophobia or redness, which may be a clinical sign attributable to hypersensitivity. There is a potential risk of arterial thromboembolic events (ATEs) following intravitreal use of VEGF inhibitors, which include vascular death, non-fatal strokes and non-fatal myocardial infarction, with the risk of stroke potentially greater in patients with known risk factors including a history of stroke or transient ischaemic attack. Bilateral treatment with AFQLIR should be avoided; the safety and efficacy of bilateral treatment with aflibercept have not been systematically studied, and bilateral treatment at the same time could lead to increased systemic exposure and increased risk of systemic adverse events.

Contraindications

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

PBS listing

AFQLIR solution for intravitreal injection 6.6 mg in 165 microlitres (40 mg per mL) pre-filled syringe is listed on the PBS with 8 items under streamlined and authority-required restrictions, with an ex-manufacturer price of A$269.54 as of the schedule dated 2026-05-01.

Regulatory history

AFQLIR was first listed on the ARTG on 2025-05-27 with two registered entries: ARTG 445959 for the pre-filled syringe formulation and ARTG 445960 for the vial with needle formulation. The AusPAR (Australian Public Assessment Report) was approved on 2025-05-15. The PBAC recommended AFQLIR in July 2025 for macular oedema secondary to retinal vein occlusion, diabetic macular oedema, and subfoveal choroidal neovascularisation secondary to age-related macular degeneration. It was recommended for biosimilars under the same conditions as their reference biologic, Eylea.