Outlook Therapeutics submits Type A meeting request to FDA

Outlook Therapeutics (OTLK) announced that a Type A Meeting request has been submitted to the U.S. Food and Drug Administration to discuss the complete response letter dated August 27, 2025 regarding the biologics license application resubmission for ONS-5010, an investigational ophthalmic formulation of bevacizumab under development to treat wet AMD. In the FDA’s recently issued CRL, although the Agency acknowledged the NORSE TWO pivotal trial met its safety and efficacy endpoints, it recommended that confirmatory evidence of efficacy be submitted to support the application for ONS-5010. The requested Type A meeting seeks to clarify the details of the confirmatory evidence required by the FDA.