Lytenava

Nearly 20 million U.S. adults live with some form of age-related macular degeneration (AMD). Wet AMD accounts for approximately 10% of AMD cases but is responsible for 90% of legal blindness attributable to AMD. Global AMD prevalence was estimated at 196 million people in 2020, projected to increase to 288 million by 2040. In a U.S. claims analysis, the estimated annual all-cause cost for a patient with neovascular AMD (nAMD) was $24,520, and global estimates place the cost of visual impairment due to AMD at $343 billion, including $255 billion in direct healthcare costs.

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.

No published cost-effectiveness analysis, budget impact model, or health technology assessment of bevacizumab-vikg has been identified. Outlook Therapeutics established a U.S. wholesale acquisition cost of $485 per vial on September 16, 2026. As of the report date, bevacizumab-vikg had not yet launched commercially in the United States; the company has stated it expects to make the product available to eligible patients before the end of calendar 2026 and has described the potential to exceed $500 million in annual U.S. sales by 2030.

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.