According to the interim results of the RIVAL trial, ranibizumab (Lucentis) showed an increase of 2.2 more letters compared to aflibercept.
Data from the 1-year interim results of the phase IV RIVAL study have shown ranibizumab’s (Lucentis) performance compared to aflibercept in patients with neovascular (wet) age-realted macular degeneration (AMD).
The study data was presented at the 17th EURETINA Congress in Barcelona, Spain.
In the RIVAL study, 278 patients were randomized to a treat-and-extend-treatment regimen of 0.5 mg ranibizumab, produced by Novartis and Genentech, and 2.0 mg aflibercept. The ranibizumab arm improved patients’ vision by an average of 7.1 letters compared to 4.9 letters (p=0.063) at 12 months, measured as Best Corrected Visual Acuity (BVCA) and with both groups receiving the same number of injections.
"We are delighted by the RIVAL data, which confirms unsurpassed efficacy of Lucentis," Vas Narasimhan, the global head of drug development and chief medical officer at Novartis, said in a statement. "Both RIVAL and LUMINOUS demonstrate our commitment to further invest in the science of this product, a standard of care in the treatment of nAMD for over a decade. We look forward to seeing the full RIVAL dataset next year."
Additionally, the 5-year LUMINOUS study, which assessed the real-world efficacy of ranibizumab in more than 30000 patients with diabetic macular edema, branch retinal vein occlusion, central retinal vein occlusion and myopic choroidal neovascularization, confirmed both its safety profile and its efficacy in treating.
LUMINOUS was the largest study ever in retinal disease, according to Novartis. Its primary endpoints included “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,” per Novartis.
Ranibizumab also outperformed laser photocoagulation in patients with proliferative diabetic retinopathy, with statistically significant differences inn eovascularization (-3.8 mm2 compared to -0.9 with laser), central subfield retinal thickness (-5.3 μm in compared to 35.4 with laser), and 1.1 letter BCVA gain compared to -3.7 in the laser group.
The RIVAL study is a 24-month study conducted to compare ranizbizumab and aflibercept, and its primary endpoints were defined as mean change in the area of geographic atrophy (GA) from baseline to month 24. The interim results assessed secondary endpoints defined as the number of injections and change in BCVA from baseline to month 12.