07:06 AM EDT, 08/28/2025 (MT Newswires) -- Outlook Therapeutics ( OTLK ) said Thursday the US Food and Drug Administration has issued a complete response letter to its resubmitted biologics license application for ONS-5010 to treat wet age-related macular degeneration.

The company said the regulator cited a lack of substantial evidence of effectiveness, noting the therapy failed to meet the primary endpoint for effectiveness in the norse eight study.

The FDA recommended that confirmatory evidence needs to be submitted to support the application, Outlook Therapeutics ( OTLK ) said.

The company said it plans to meet with the FDA to discuss a path forward for potential approval in the US.

Shares of Outlook Therapeutics ( OTLK ) were down more than 70% in recent Thursday premarket activity.

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