Lytenava (bevacizumab-vikg)

Bevacizumab-vikg (Lytenava) is a vascular endothelial growth factor (VEGF) inhibitor formulated for intravitreal injection, dosed at 1.25 mg once monthly. In the pivotal phase 3 NORSE TWO trial, 41.7% of participants receiving bevacizumab-vikg (45 of 108 evaluable) gained 15 or more Early Treatment Diabetic Retinopathy Study (ETDRS) letters of best corrected visual acuity (BCVA) from baseline to Month 11, compared with 23.1% (24 of 104) receiving ranibizumab 0.5 mg dosed monthly for 3 months then quarterly (risk difference 0.1859, 95% CI 0.0442 to 0.3086). In the confirmatory NORSE EIGHT trial, 400 participants were randomized 1:1 to bevacizumab-vikg or monthly ranibizumab 0.5 mg for 3 doses; at Week 8, the primary endpoint of mean BCVA change did not meet its pre-specified non-inferiority margin of -3.5 letters (bevacizumab-vikg +3.3 letters versus ranibizumab +4.5 letters; least-squares mean difference -2.3, 95% CI -4.0 to -0.5), although bevacizumab-vikg showed a BCVA increase at Week 12 consistent with NORSE TWO. Across 601 participants in five clinical trials, the most common adverse reaction (occurring in 4% of participants) was conjunctival hemorrhage, compared with 3% for ranibizumab; eye pain and vitreous floaters each occurred in 2% of participants receiving bevacizumab-vikg compared with 1% for ranibizumab. Labeled warnings include endophthalmitis and retinal detachment, increases in intraocular pressure, and a potential risk of arterial thromboembolic events associated with VEGF inhibition.