FDA approves first ophthalmic bevacizumab for wet AMD

FDA has approved Lytenava (bevacizumab-vikg) for the treatment of neovascular (wet) age-related macular degeneration (AMD), making it the first and only FDA-approved ophthalmic formulation of bevacizumab in the US. According to the manufacturer, the product was specifically developed for intravitreal administration and is supported by clinical trial data, validated manufacturing processes, approved labeling, and FDA regulatory oversight.

The approval is notable because bevacizumab has been widely used for years as a lower-cost anti-VEGF therapy in retinal disease, despite lacking an FDA-approved ophthalmic formulation. Instead, clinicians have relied on repackaged aliquots derived from IV oncology products. Lytenava introduces a purpose-built ophthalmic bevacizumab with standardized manufacturing and quality controls intended for retinal use.

For retina specialists, the approval could influence treatment selection, payer coverage discussions, and patient access strategies. Wet AMD remains a leading cause of vision loss in older adults and often requires long-term anti-VEGF treatment. The availability of an FDA-approved bevacizumab product may appeal to clinicians seeking a regulated alternative to compounded formulations while maintaining a familiar anti-VEGF mechanism of action.

Outlook Therapeutics said commercial launch activities are underway, with US availability anticipated before year-end, alongside reimbursement and patient-support programs.

Source: Outlook Therapeutics. (2026 July 24). Outlook Therapeutics Announces LYTENAVA™ FDA Approval as the First and Only FDA-Approved Ophthalmic Bevacizumab for the Treatment of Wet AMD