Outlook submits BLA to FDA for ophthalmic bevacizumab in wet AMD

Outlook Therapeutics (Nasdaq: OTLK) today said it has submitted its Biological License Application (BLA) to the US Food and Drug Administration for ONS-5010, an investigational therapy which, if approved, will be branded as Lytenava (bevacizumab-vikg), for the treatment of wet age-related macular degeneration (wet AMD).

Surprisingly, the market’s reaction was negative, with Outlook’s shares down 3.8% at $1.92 following the announcement.

If approved, ONS-5010 could replace the current practice of using unapproved repackaged IV bevacizumab sourced from compounding pharmacies for the treatment of wet AMD. The company expects to receive notification in 60 days from the FDA on a decision of acceptance of the BLA, with the PDUFA date for potential approval. If approved, ONS-5010 is expected to be granted 12 years marketing exclusivity.