FDA Accepts BLA for ONS-5010 in Wet AMD

The U.S. Food and Drug Administration (FDA) has accepted the resubmitted Biologics License Application (BLA) for ONS-5010 (bevacizumab-vikg) from Outlook Therapeutics, for the treatment of wet age-related macular degeneration (AMD).

BLA Resubmission Receives Class 2 Review Status

Outlook Therapeutics confirmed that the BLA resubmission, made in February 2025, has been designated as a Class 2 review by the FDA. This classification corresponds to a six-month review period, starting from the date of resubmission.

The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target date of August 27, 2025. If approved, the therapy will be branded as LYTENAVA in the United States.

Company Statement on Regulatory Progress

Lawrence Kenyon, Chief Financial Officer and Interim CEO of Outlook Therapeutics, highlighted the significance of the BLA acceptance:

“Our team has worked diligently to advance our development and regulatory strategies for ONS-5010 to get to this point, and we are proud of the continued progress we have been able to achieve. 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 an ophthalmic bevacizumab to market in the United States and are continuing our activities for potential commercialization.”

Regulatory History and Basis for Resubmission

The current BLA resubmission follows a Complete Response Letter (CRL) issued by the FDA in August 2023. At that time, the FDA cited issues related to chemistry, manufacturing, and controls (CMC), observations from pre-approval inspections, and an overall lack of substantial evidence to support approval.

In response, Outlook Therapeutics provided new data from its NORSE EIGHT clinical trial and additional CMC information requested by the agency. A Type A meeting with the FDA clarified that a non-inferiority study comparing ONS-5010 to ranibizumab could serve as the basis for BLA resubmission. This 12-week trial, conducted in treatment-naïve patients, evaluated efficacy at 8 weeks.

NORSE EIGHT Results Support Clinical Benefit

In January 2025, the company announced the completed analysis of 12-week safety and efficacy data from NORSE EIGHT. The findings indicated that ONS-5010 achieved clinically meaningful anatomic and functional improvements at all measured timepoints.

Outlook Therapeutics stated that this dataset provides the required evidence to support regulatory approval of the BLA in the U.S.

Mechanism of Action of Bevacizumab-vikg

ONS-5010 (bevacizumab-vikg) is a recombinant humanized monoclonal antibody that selectively binds to all isoforms of vascular endothelial growth factor (VEGF). It neutralizes VEGF activity by sterically blocking its binding to endothelial cell surface receptors Flt-1 (VEGFR-1) and KDR (VEGFR-2), which are implicated in the angiogenic processes that drive wet AMD.