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Lucentis Efficacy and Durability Reported

mivision | 27 October 2017
Novartis has reported new data confirming Lucentis (ranibizumab) efficacy and durability in patients with nAMD.

One-year interim results from the Phase IV head-to-head RIVAL study compared ranibizumab versus aflibercept using a treat and- extend treatment regimen in patients with neovascular age-related macular degeneration (nAMD).

Additionally, five-year results from the LUMINOUS study confirmed the real-world efficacy and safety of Lucentis in patients with nAMD, visual impairment due to diabetic macular edema, branch retinal vein occlusion, central retinal vein occlusion and myopic choroidal neovascularisation.

The LUMINOUS study assessed the long-term effects of Lucentis in more than 30,000 patients being treated across five different eye diseases in 43 countries across 494 sites, making this the largest-ever study in retinal disease.

Primary endpoints include mean visual acuity (VA), mean change in VA at three, six and 12 months from baseline visit, and annually thereafter; incidence rate, relationship and severity of treatment-emergent ocular and non-ocular adverse events (AEs) and mean visual acuity at quarterly intervals for the primary treated eye set.

The RIVAL study is a 24-month, randomised, controlled, multi-centre, Phase IV study conducted in Australia. It is the first head-tohead clinical trial designed to compare Lucentis with aflibercept in patients with neovascular age-related macular degeneration (nAMD) using the same treat-and-extend regimen.

A total of 278 treatment naive patients are enrolled in the RIVAL study and randomised to receive either Lucentis 0.5 mg or aflibercept 2.0 mg over the 24-month study period. Patients eligible for inclusion in the study included visual impairment of >=23 letters on a Logarithm of Minimal Angle of Resolution (LogMAR) chart. After receiving three initial monthly injections, patients entered the treatment and extension phase of the study, whereby the treatment interval was extended by two weeks at a time to a maximum of 12 weeks.

The primary efficacy endpoint of the RIVAL study is defined as mean change in the area of geographic atrophy (GA) from baseline to month 24. Results from a pre-planned 12-month interim analysis assessed key secondary endpoints: number of injections and change in BCVA from baseline to month 12.

The results were presented at the 17th EURETINA Congress in Barcelona (7–10 September, 2017). Full results of the study are anticipated in 2018.

' interim results from the Phase IV head-to-head RIVAL study compared ranibizumab versus aflibercept using a treatand- extend treatment regimen '