Outlook Therapeutics announced it has received U.S. Food and Drug Administration (FDA) approval for its biologics license application for LYTENAVA™ (bevacizumab-vikg). This approval marks LYTENAVA™ as the first and only ophthalmic formulation of bevacizumab specifically approved for the treatment of neovascular (wet) age-related macular degeneration (wet AMD). The company is now executing its U.S. commercial launch plan.
Key Details
- Product Approval: LYTENAVA™ (bevacizumab-vikg) is the first and only FDA-approved ophthalmic formulation of bevacizumab for the treatment of wet AMD in the U.S.
- Market Opportunity: The company is entering the U.S. anti-VEGF retina market, which is estimated to be approximately $8.5 billion annually.
- Exclusivity & Launch: Outlook Therapeutics anticipates 12 years of market exclusivity under the Biologics Price Competition and Innovation Act (BPCIA) and plans to make the product available to U.S. patients before the end of 2026.