LUCENTIS

What it is

Lucentis contains ranibizumab (rbe), a humanised monoclonal antibody fragment produced in Escherichia coli cells by recombinant DNA technology. It is supplied as a vial containing 2.3 mg of ranibizumab in 0.23 mL solution for intravitreal injection, or as a pre-filled syringe containing 1.65 mg of ranibizumab in 0.165 mL solution. The solution is sterile, clear, colourless to pale brownish-yellow, aqueous and preservative free.

Approved indications Lucentis is indicated in adults for:

— the treatment of neovascular (wet) age-related macular degeneration (AMD) — the treatment of visual impairment due to diabetic macular oedema (DME) — treatment of proliferative diabetic retinopathy (PDR) — the treatment of visual impairment due to choroidal neovascularisation (CNV) — the treatment of visual impairment due to choroidal neovascularisation (CNV) secondary to pathologic myopia (PM) — the treatment of visual impairment due to macular oedema secondary to retinal vein occlusion (RVO) Lucentis is indicated in preterm infants for the treatment of retinopathy of prematurity (ROP) with zone I (stage 1+, 2+, 3 or 3+), zone II (stage 3+) or AP-ROP (aggressive posterior ROP) disease.

Dosing overview

The recommended dose for Lucentis in adults is 0.5 mg given as a single intravitreal injection, corresponding to an injection volume of 0.05 mL. The interval between two doses injected into the same eye should be at least four weeks. Treatment in adults is initiated with one injection per month until maximum visual acuity is achieved and/or there are no signs of disease activity. In patients with wet AMD, DME, PDR, and RVO, initially three or more consecutive monthly injections may be needed. For preterm infants, the recommended dose is 0.2 mg given as an intravitreal injection, corresponding to 0.02 mL, or alternatively a dose of 0.1 mg corresponding to 0.01 mL can be given. Treatment of ROP is initiated with a single injection per eye and may be given bilaterally on the same day. In total, up to three injections per eye may be administered within six months of treatment initiation if there are signs of disease activity.

Key safety warnings

Use of more than one injection from a vial can lead to product contamination and subsequent ocular infection. Lucentis must be administered by a qualified ophthalmologist experienced in intravitreal injections. Lucentis may contain potential allergens: traces of milk and residue of tetracycline (antibiotic) from the manufacturing process. The injection procedure should be carried out under aseptic conditions, which include the use of surgical hand disinfection, sterile gloves, a sterile drape and a sterile eyelid speculum (or equivalent). Sterile paracentesis equipment should be available as a precautionary measure.

Contraindications

The patient's medical history should be carefully evaluated for hypersensitivity reactions prior to performing the intravitreal procedure.

PBS listing

Lucentis is listed on the PBS in two formulations: solution for intravitreal injection 1.65 mg in 0.165 mL pre-filled syringe and solution for intravitreal injection 2.3 mg in 0.23 mL vial. Both formulations have 8 PBS items with streamlined authority required restrictions. The ex-manufacturer price is A$689.04 per injection.

Regulatory history

The vial formulation (2.3 mg/0.23 mL) was first registered on the ARTG on 10 November 2008, followed by the pre-filled syringe formulation (1.65 mg/0.165 mL) on 5 November 2013. In November 2014, the PBAC recommended Lucentis for the treatment of diabetic macular oedema. In November 2017, the PBAC recommended a new indication for treatment of visual impairment due to myopic choroidal neovascularisation, and an amendment to allow use for diabetic macular oedema in patients with best corrected visual acuity of less than or equal to 6/12. An AusPAR was issued on 28 April 2014 for the indication of treatment of visual impairment due to choroidal neovascularisation secondary to pathologic myopia. In May 2025, the PBAC recommended Lucentis for the treatment of proliferative diabetic retinopathy with or without diabetic macular oedema.