Retina specialists weigh in on FDA approval of bevacizumab-vikg (Lytenava) for wet AMD

On July 24, 2026, Outlook Therapeutics announced the FDA approval of bevacizumab-vikg (ONS-5010; Lytenava) for the treatment of wet age-related macular degeneration (AMD). The approval follows three prior Complete Response Letters (CRLs)¹ and a successful appeal through the FDA’s Formal Dispute Resolution process² and makes the product the first and only FDA-approved ophthalmic formulation of bevacizumab for the treatment of wet AMD in the United States.³ The product is already commercially available in Germany, Austria, and the UK, offering an early look at real-world uptake ahead of its US launch, which the company expects to complete before year-end.³