05:22 PM EST, 03/05/2026 (MT Newswires) -- Outlook Therapeutics ( OTLK ) provided an update late Thursday after its recent Type A meeting with the US Food and Drug Administration to discuss the Dec. 30 complete response letter for the biologics license application for ONS-5010/LYTENAVATM.

Outlook said the meeting was to clarify the outstanding issue of substantial evidence of effectiveness and to discuss potential paths forward for regulatory approval.

The company said it expects to engage in more discussions with the FDA to clarify the regulator's views on confirmatory evidence.

ONS-5010/LYTENAVATM is currently an investigational drug in the United States. If approved, it has the potential to be the first ophthalmic formulation of bevacizumab-vikg approved by the FDA for use in ophthalmology, the company added.