The FDA approved Outlook Therapeutics' Lytenava (bevacizumab-vikg) to treat wet age-related macular degeneration (AMD).
Lytenava is the first ophthalmic formulation of bevacizumab officially sanctioned for this indication in the U.S. Physicians previously relied on off-label bevacizumab for years to treat this leading cause of vision loss.
The approval follows a regulatory process involving multiple complete response letters from the agency. Outlook Therapeutics expects 12 years of market exclusivity for the drug.
The company plans to launch Lytenava in the U.S. market before the end of 2026. Regulators in the European Union and the United Kingdom have already approved the treatment.