Lytenava (bevacizumab-vikg)

The FDA approved bevacizumab-vikg (Lytenava) on July 24, 2026, for neovascular (wet) age-related macular degeneration, after three Complete Response Letters and the addition of a second adequate and well-controlled trial (NORSE EIGHT) to the original NORSE TWO pivotal trial. It is the first FDA-approved ophthalmic formulation of bevacizumab, an antibody that has long been used off-label as a compounded, repackaged intravenous oncology product for wet AMD because of its comparatively low cost. Approval rests primarily on NORSE TWO, in which bevacizumab-vikg dosed monthly outperformed a less frequently dosed ranibizumab regimen on a visual-acuity-gain endpoint at 11 months, while the confirmatory NORSE EIGHT trial did not meet its pre-specified non-inferiority margin against monthly ranibizumab at Week 8, though the two arms converged by Week 12. No published budget impact model, ASP, or peer-reviewed NORSE EIGHT publication was identified as of the report date, and commercial launch, reimbursement coding, and real-world experience remain pending.