The Therapeutic Goods Administration (TGA) has granted Lucentis (ranibizumab) an indication for retinopathy of prematurity (ROP), making it the first anti-VEGF therapy approval for the rare disease affecting premature infants in Australia.
Novartis Australia recently announced the therapy’s approval for ROP zone I (stage 1+, 2+, 3 or 3+), zone II (stage 3+) or AP ROP (aggressive posterior ROP). There are five different stages defining the severity of disease, with stage 5 indicating a total retinal detachment.
According to Novartis, by targeting and reducing the level of VEGF, a key factor in the progression of ROP, Lucentis may help avoid some of the common complications associated with eye tissue damage like severe near-sightedness. In targeting VEGF, Lucentis acts differently to laser therapy, which is currently the first line treatment in Australia.
ROP affects the vision and is caused by abnormal development of retinal blood vessels in premature infants. The blood vessels deliver oxygen to the retina. Imbalances or blockages in the oxygen circulation process may result in vision loss or blindness.
ROP most commonly occurs in preterm infants less than 30 weeks’ gestation, with close to 50% of babies born ≤24 weeks’ gestation having severe ROP. In infants registered to the Australian and New Zealand Neonatal Network, the ROP incidence depends most on gestation at birth, with close to 50% born ≤24 weeks’ gestation having some stage 3-4.
The Lucentis approval is based on the Phase 3 RAINBOW study comparing the efficacy and safety of Lucentis with laser surgery in preterm infants with ROP.
It marks the seventh indication for Lucentis in Australia, which is commonly used to treat neovascular age-related macular degeneration, as well as diabetic macular oedema, proliferative diabetic retinopathy, visual impairment due to choroidal neovascularisation, visual impairment due to choroidal neovascularisation secondary to pathologic myopia, and visual impairment due to macular oedema secondary to retinal vein occlusion.
“Lucentis’ approval for retinopathy of prematurity means that premature babies with severe sight threatening disease have an effective medicine which is approved for intraocular use,” Sydney-based paediatric ophthalmologist Dr Jeremy Smith said.
Mr Richard Tew, Novartis Australia and New Zealand country president, said the indication was an important milestone for families affected by ROP.
“The impact of ROP on preterm infants can be devastating if left untreated, in some cases leading to blindness,” he said.
“This approval demonstrates Novartis’ commitment in ophthalmology and in developing and delivering innovative treatments to serve the needs of patients with a number of eye conditions, from rare diseases to those affecting millions.”
A long-term extension trial is currently under way and expected to conclude by Q4 of 2022. Use of Lucentis in paediatric ROP patients is subject to additional monitoring in Australia, allowing quick identification of new safety information.
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