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Outlook Receives FDA Agreement under SPA for Ophthalmic Bevacizumab Formulation Trial

Jan 23, 2024

Outlook Therapeutics announced it received an agreement from the FDA under a Special Protocol Assessment (SPA) for its clinical trial protocol to assess ONS-5010, an ophthalmic formulation of bevacizumab.  Outlook expects to commence the trial in Q1 2024, with potential resubmission of its biologics license application (BLA) by the end of 2024.  Outlook has also entered into securities purchase agreements for up to $172M to fund the advancement of ONS-5010.

Outlook submitted its SPA request to the FDA regarding the design of the study on 19 December 2023.