USFDAJul 24, 2026, 02:46 PM
Outlook Therapeutics' LYTENAVA™ gets FDA approval for wet AMD
AI Summary
Outlook Therapeutics announced that the U.S. Food and Drug Administration (FDA) has approved LYTENAVA™ (bevacizumab-vikg) for the treatment of neovascular age-related macular degeneration (wet AMD). This approval establishes LYTENAVA™ as the first and only FDA-approved ophthalmic formulation of bevacizumab for wet AMD in the United States, providing retina specialists and patients with a purpose-built treatment. The company anticipates 12 years of market exclusivity and has commenced commercial launch activities, aiming to make the product available to U.S. patients before year-end in the approximately $8.5 billion U.S. retina market.
Key Highlights
- FDA approved LYTENAVA™ (bevacizumab-vikg) for neovascular age-related macular degeneration (wet AMD).
- LYTENAVA™ is the first and only FDA-approved ophthalmic formulation of bevacizumab for wet AMD.
- Company anticipates 12 years of market exclusivity for LYTENAVA™ under the BPCIA.
- The U.S. anti-VEGF retina market is estimated at approximately $8.5 billion annually.
- Outlook Therapeutics is executing the commercial launch of LYTENAVA™.
- LYTENAVA™ is expected to be available to eligible U.S. patients before year-end.
- LYTENAVA™ also holds Marketing Authorization in the EU and UK for wet AMD.
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