ARTICLE
31 July 2026

Outlook Therapeutics Secures FDA Approval For LYTENAVA™

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Outlook Therapeutics has achieved a significant regulatory milestone with FDA approval of LYTENAVA™, the first ophthalmic formulation of bevacizumab specifically developed for treating neovascular age-related macular degeneration. While bevacizumab has been used off-label in retina care through repackaged oncology formulations, this marks the first FDA-approved version designed specifically for intravitreal ophthalmic use, with the product expected to receive 12 years of exclusivity under the BPCIA.
United States Food, Drugs, Healthcare, Life Sciences
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On July 24, 2026, Outlook Therapeutics, Inc. announced that the FDA approved LYTENAVA™ (bevacizumab-vikg) for the treatment of neovascular age-related macular degeneration (known as “nAMD” or “wet AMD”), marking the first FDA-approved ophthalmic formulation of bevacizumab in the United States. According to Outlook, bevacizumab has long been used off label in retina care through repackaged oncology formulations, but LYTENAVA™ is the first formulation specifically developed and approved for intravitreal ophthalmic use. Outlook also announced that the product is expected to receive 12 years of Reference Product Exclusivity under the Biologics Price Competition and Innovation Act (“BPCIA”). Outlook is preparing for commercial launch and expects to make LYTENAVA™ available to patients before the end of the year.

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