Outlook Therapeutics Resubmits Biologics License Application to FDA for Wet AMD Drug Candidate ONS-5010

Outlook Therapeutics announced it has resubmitted its biologics license application (BLA) to the FDA for ONS-5010, an investigational ophthalmic therapy which, if approved, will be branded as Lytenava (bevacizumab-vikg) for the treatment of wet age-related macular degeneration (AMD).

Outlook original submitted the BLA for ONS-5010/ Lytenava to the FDA in March 2022. However, in May, the FDA requested additional information in order to complete the filing of the BLA.

“Over the past 3 months, we have worked diligently to provide the additional required information that was not included in our March 2022 BLA submission, to address requests from the agency to ensure our BLA is complete for acceptance and review. We believe that this resubmission addresses each of the comments and recommendations from the agency, and we are confident in the revised BLA application,” Russell Trenary, president and CEO of Outlook Therapeutics, said in a company news release. “We remain committed to bringing ophthalmic bevacizumab to market, which, if approved, can provide retina patients with an on-label treatment option that helps patients avoid the health risks associated with unapproved repackaged oncologic IV bevacizumab.”

“Our NORSE TWO pivotal trial for ONS-5010 showed compelling efficacy and clinical relevance coupled with a robust safety profile, and we are confident that our investigational drug, if approved, will be a valuable therapeutic option to treat retina diseases,” added Terry Dagnon, COO of Outlook Therapeutics. “ONS-5010 is designed and manufactured to be fully compliant with FDA’s criteria for ophthalmic biologics to meet the public health need for an FDA-approved ophthalmic formulation of bevacizumab.”

In anticipation of potential FDA marketing approval in 2023, Outlook Therapeutics has continued its commercial launch planning. These activities include establishing partnerships with FUJIFILM Diosynth Biotechnologies for drug substance, and with drug product manufacturer Ajinomoto Bio-pharma Services for finished drug product. Outlook Therapeutics is also actively building out its distribution and commercial capabilities.