Outlook Therapeutics' ONS-5010 For The Treatment Of Wet AMD Biologics License Application Accepted By FDA

Outlook Therapeutics has announced that the U.S. FDA has accepted the resubmission of its Biologics License Application (BLA) for ONS-5010 (bevacizumab-vikg), an investigational ophthalmic formulation intended for treating wet age-related macular degeneration (wet AMD). Already approved in the EU and the UK, the product could become the first authorised ophthalmic version of bevacizumab in the U.S. The ongoing evaluation of the resubmission received Class 2 review status, which requires a six-month review duration leading to an August 27, 202,5, PDUFA target date. Following regulatory approval, the drug will launch as LYTENAVA™ following regulatory approval and benefit from twelve years of market exclusivity.

“Our team has worked diligently to advance our development and regulatory strategies for ONS-5010 to reach this point, and we are proud of our continued progress. This BLA acceptance and PDUFA date are significant milestones in our continued mission to offer clinicians and their patients the first and only on-label, ophthalmic bevacizumab to treat wet AMD. We are committed to bringing ophthalmic bevacizumab to market in the United States and are continuing our activities for potential commercialisation,” commented Lawrence Kenyon, Chief Financial Officer and Interim Chief Executive Officer of Outlook Therapeutics.“

The new BLA filing includes clinical data from NORSE EIGHT, a non-inferiority study comparing ONS-5010 to ranibizumab in treatment-naïve wet AMD patients. The study focused on an 8-week primary endpoint and was designed to fulfil FDA requirements following a previous Complete Response Letter (CRL). This data, combined with additional chemistry, manufacturing, and controls (CMC) information requested by the FDA, forms the basis of the resubmission. Outlook Therapeutics believes the NORSE EIGHT trial and prior data from other NORSE clinical studies present a strong evidence package to secure FDA approval in the U.S.