New clinical and real world data further confirms the safety profile and efficacy of Lucentis (ranibizumab) and supports a flexible dosing approach
Real world data presented by Novartis at the 2014 Association for Research in Vision and Ophthalmology (ARVO) Conference this week further support the well-established safety and efficacy profile of Lucentis® (ranibizumab) in wet Age-related Macular Degeneration (AMD). Pivotal clinical trial results also show a flexible dosing approach in patients with Diabetic Macular Oedema (DMO) is non-inferior to a regimen which requires monthly monitoring.
One year results from the LUMINOUS trial, the largest ongoing trial in ophthalmology, showed that wet AMD patients with no prior ranibizumab treatment (n = 275), gained nearly one line of vision (+4.1 ETDRS letters from baseline). Results showed that wet AMD patients with prior treatment (n = 1,829), including those with more than six years of ranibizumab treatment, maintained their vision in the first year of the LUMINOUS study. No new safety findings were identified. To date, the UK has recruited more than 8,000 patients in the LUMINOUS trial and the study hopes to recruit 30,000 patients from approximately 600 sites across 41 countries worldwide.
In DMO, disease activity and injection requirements differ from one patient to another, thereby supporting flexible treatment regimens. Results presented from the Phase IIIb RETAIN study showed a treat-and-extend (TE) treatment schedule*, which involves flexible dosing intervals, was non-inferior to a pro re-nata (PRN) regimen, which provided flexible dosing with monthly monitoring. The TE regimen was also associated with a reduction in patient monitoring visits, compared to PRN.
- Patients on the TE regimen had very similar visual outcomes compared to PRN regimen (mean average change at month 12 of +6.1 letters and +6.2 letters respectively) with gains maintained during the 2nd full year of treatment.
Further ranibizumab data of interest presented at ARVO, included a post-hoc analysis of the RADIANCE study, which compared ranibizumab treatment outcomes in East-Asian and Caucasian patients with myopic CNV. The study showed that ranibizumab treatment leads to best corrected visual acuity (BCVA) improvements in patients with myopic choroidal neovascularisation (myopic CNV) and findings suggest that East-Asians, in whom myopic CNV is more common than in Caucasians, have higher BCVA gains than Caucasians after 12 months of treatment with ranibizumab (16.1 ETDRS letters with a median of 2 injections vs 14.1 ETDRS letters with a median of 3 injections).
Ranibizumab, is the only anti-VEGF treatment licensed and approved by the National Institute for Health and Care Excellence (NICE) and the Scottish Medicines Consortium (SMC) across four ophthalmic indications for appropriate patients, including wet AMD, DMO, myopic CNV and visual impairment due to macular oedema secondary to Branch and Central Retinal Vein Occlusion (BRVO and CRVO).,,,,,,,
*Treat-and-extend (TE) is outside the UK licence for ranibizumab. Please refer to ranibizumab SmPC for details: http://www.medicines.org.uk/emc/medicine/19409/SPC/Lucentis+10+mg+ml+solution+for+injection
 Paul Mitchell. ARVO 2014 Annual Meeting Abstracts. Ranibizumab in the real world clinical setting: results from the one year interim analysis of the LUMINOUS study
 Christian Pruente. ARVO 2014 Annual Meeting Abstracts. Efficacy and safety of ranibizumab in two treat-and-extend versus pro-re-nata regimes in patients with visual impairment due to diabetic macular edema: 24-month results of RETAIN study
 Timothy Lai, Kyoko Ohno-Matsui, Tien Y. Wong, Paolo Lanzetta, Stefan Pilz, Nikol Heinrichs. ARVO 2014 Annual Meeting Abstracts. Comparison of visual acuity outcomes and ranibizumab treatment exposure in East-Asian and Caucasian patients with visual impairment due to myopic CNV: a RADIANCE study subgroup analysis
 NICE TA155 Macular degeneration (age-related) – ranibizumab and pegaptanib: guidance. http://guidance.nice.org.uk/TA155/Guidance/pdf/English. Accessed May 2014
 SMC. Ranibizumab (Lucentis) Novartis Pharmaceuticals UK Ltd SMC No. (381/07) – May 2007
 SMC, 2013, ranibizumab, 10mg/mL, solution for injection (Lucentis®) SMC No. (907/13)
 NICE TA274 Ranibizumab for treating diabetic macular oedema. http://publications.nice.org.uk/ranibizumab-for-treating-diabetic-macular-oedema-rapid-review-of-technology-appraisal-guidance-ta274. Accessed May 2014
 NICE TA283. Ranibizumab for treating visual impairment caused by macular oedema secondary to retinal vein occlusion. Available at http://guidance.nice.org.uk/TA283. Accessed May 2014
 SMC. Ranibizumab (Lucentis) Novartis Pharmaceuticals UK Ltd SMC No. (711/11) – November 2012
 SMC. Ranibizumab (Lucentis) Novartis Pharmaceuticals UK Ltd SMC No. (732/11) – April 2013
 Lucentis SmPC: http://www.medicines.org.uk/emc/medicine/19409/SPC/Lucentis+10+mg+ml+solution+for+injection/. Accessed May 2014