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TGA Approves for Lucentis for ROP

Lucentis (ranibizumab) has been approved by the Therapeutics Goods Administration (TGA) for the treatment of retinopathy of prematurity (ROP), a rare and potentially blinding disease in premature infants.4 This is the first approval of an anti-vascular endothelial growth factor (VEGF).

Novartis says Lucentis may help avoid some of the common complications associated with eye tissue damage like severe nearsightnedness by targeting and reducing the level of VEGF, a key factor in the progression of ROP.1,5,6,7

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

ROP is caused by abnormal development of retinal blood vessels in premature infants, where imbalances or blockages in the oxygen circulation process may result in vision loss or blindness.7 There are five stages of the disease, with the final stage indicating a total retinal detachment.1 Close to 50% of babies born ≤24 weeks’ gestation registered to the Australian and New Zealand Neonatal Network have some stage 3-4 of ROP.3

“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,” said Dr Jeremy Smith, Paediatric Ophthalmologist.

Richard Tew, Novartis Australia and New Zealand Country President, said the indication of Lucentis for ROP is an important milestone for families impacted by this rare disease.

“The impact of ROP on preterm infants can be devastating if left untreated, in some cases leading to blindness.”

He says the 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.”

The approval of Lucentis is based on the Phase III RAINBOW study,9 designed to compare the efficacy and safety of Lucentis with laser surgery in preterm infants with ROP. A long-term extension trial is currently underway.9


  1. Victorian Agency for Health Information, Better Care. Retinopathy in prematurity. 2018, https://www.bettersafercare.vic.gov.au/clinical-guidance/neonatal/retinopathy-of-prematurity-rop, [Accessed January 2022]
  2. Australian Institute of Health and Welfare (2021), Australia’s mothers and babies., AIHW, Australian Government, [Accessed 13 January 2022]
  3. Australian and New Zealand Neonatal Network 2021. Report of the Australian and New Zealand Neonatal Network 2019, https://anznn.net/Portals/0/AnnualReports/Report%20of%20the%20Australian%20and%20New%20Zealand%20Neonatal%20Network%202019.pdf, [Accessed January 2022]
  4. Lucentis PI.
  5. Mintz-Hittner, H., Kennedy, K. and Chuang, A. (2011). Efficacy of Intravitreal Bevacizumab for Stage 3+ Retinopathy of Prematurity. New England Journal of Medicine, 364(7), pp.603-615.
  6. Blencowe, H., Lawn, J., Vazquez, T., Fielder, A. and Gilbert, C. (2013). Preterm-associated visual impairment and estimates of retinopathy of prematurity at regional and global levels for 2010. Nature, 74(s1), pp.35-49.
  7. Keshet, E. (2003). Preventing pathological regression of blood vessels. Journal of Clinical Investigation, 112(1), pp.27-29.
  8. Medicines.org.uk. (2018). Lucentis 10 mg/ml solution for injection – Summary of Product Characteristics (SmPC) – (eMC). [online] Available at: https://www.medicines.org.uk/emc/product/307/smpc [Accessed January 2022].
  9. Clinicaltrials.gov. (2018). RAINBOW Study: Ranibizumab Compared With Laser Therapy for the Treatment of INfants BOrn Prematurely With Retinopathy of Prematurity – Study Results – ClinicalTrials.gov. [online] Available at: https://clinicaltrials.gov/ct2/show/results/NCT02375971 [Accessed January 2022].
  10. Moorfields.nhs.uk. (2018). Anatomy of the eye – Moorfields Eye Hospital. [online] Available at: https://www.moorfields.nhs.uk/content/anatomy-eye [Accessed January 2022].