Novartis has announced a change to the licence of Lucentis® (ranibizumab), which means treatment can now be offered without the need for monthly monitoring in patients with stable disease activity.1 The licence change will give ophthalmologists flexibility at every step of the patient's journey, right from the beginning of their diagnosis and at the start of their treatment regimen. This means that clinicians can now extend treatment or monitoring intervals in stable patients in the first year of treatment and beyond.

This label change supports the weight of evidence in ranibizumab clinical trials and practice that treatment requirements vary from patient to patient:2

  • In wet age-related macular degeneration (wet AMD) - 20% of patients require only three ranibizumab injections in first year of treatment3
  • In diabetic macular oedema (DMO) - 20% of ranibizumab treated patients did not require further injections in the remaining 2 years of the study after first year of treatment4
This personalised approach could reduce the treatment burden on patients by sparing them monthly clinic visits if they are stable on ranibizumab. The new licence could also help to reduce the burden on eye clinics and could help alleviate the capacity challenges that many clinics face, as ophthalmologists will be able to provide a flexible approach, allowing patients to receive treatment only when they need it. Monitoring and treatment intervals can now be determined by the ophthalmologist and are based on disease activity, as assessed by visual acuity and/or other anatomical parameters.

"Today is an exciting development in the story of ranibizumab. We are pleased to be providing this new personalised approach across its four licensed indications and believe it is the right approach for both patients and clinicians. We look forward to continuing to work with the ophthalmology community and offer ranibizumab as the only treatment which has been approved by NICE across wet AMD, DMO, RVO and mCNV," said Frederic Guerard, Managing Director United Kingdom and Ireland, Novartis Pharmaceuticals UK Ltd.

Ranibizumab has been proven to be effective in numerous clinical trials since its first NICE approval for wet AMD in 2008.1 The decision to harmonise the licence across all indications is in line with available clinical evidence, relevant guidelines and treatment recommendations as well as clinical practice.2 Long-term observational data is continuing to be collected as part of the LUMINOUS trial, in which currently more than 26,000 patients have been enrolled in this five-year study with over 10,000 patients recruited in the UK.5 Since it was first licensed in 2007, ranibizumab has been associated with a 50 per cent reduction in blindness due to wet AMD.1,6,7