RANIVIZ

What it is

Ranibizumab is a humanised monoclonal antibody fragment produced in Escherichia coli cells by recombinant DNA technology. RANIVIZ is supplied as a 10 mg/mL solution for injection vial or as a 1.65 mg/0.165 mL solution for injection pre-filled syringe. The solution is sterile, clear, colourless to pale brownish-yellow, aqueous and preservative free.

Approved indications RANIVIZ 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) RANIVIZ 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 RANIVIZ 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. Thereafter, monitoring and treatment intervals should be determined by the physician and should be based on disease activity, as assessed by visual acuity and/or anatomical parameters. The recommended dose for RANIVIZ in preterm infants is 0.2 mg given as an intravitreal injection, corresponding to an injection volume of 0.02 mL. 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. RANIVIZ must be administered by a qualified ophthalmologist experienced in intravitreal injections. RANIVIZ may contain potential allergens: traces of milk and residue of tetracycline (antibiotic) from the manufacturing process.

Regulatory history

RANIVIZ received approval on 2023-12-12 based on a thorough evaluation of its quality, nonclinical, and clinical data, which demonstrated its biosimilarity to Lucentis. The TGA concluded that the benefits of RANIVIZ outweigh its risks for the specified therapeutic uses. RANIVIZ was first listed on the ARTG as a 10 mg/mL solution for injection vial on 2023-12-20 under licence category RE, and as a 1.65 mg/0.165 mL pre-filled syringe on 2026-02-27. A PBAC submission was deferred in March 2022 for neovascular (wet) age-related macular degeneration responsive to prior anti-VEGF treatment, and was to be considered at a future PBAC meeting as of November 2022.