Outlook re-submits BLA to FDA for ophthalmic bevacizumab

30 August 2022

Outlook Therapeutics (Nasdaq: OTLK), a biopharmaceutical company working to develop and launch the first approved ophthalmic formulation of bevacizumab for use in retinal indications, has announced it has re-submitted its Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for ONS-5010.

If approved, this investigational ophthalmic therapy which will be branded as Lytenava (bevacizumab-vikg) for the treatment of wet age-related macular degeneration (wet AMD).

In May 2022, Outlook announced that the FDA had requested additional information in order to complete the filing of the company’s BLA for ONS-5010. Following the news, the US company voluntarily withdrew the application.

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