Outlook Therapeutics, Inc., a biopharmaceutical company working to develop and launch the first FDA-approved ophthalmic formulation of bevacizumab for use in retinal indications, announced it has re-submitted its Biologics License Application (BLA) to the U.S. Food and Drug Administration (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 (wet AMD).
“Over the past three 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 re-submission addresses each of the comments and recommendations from the Agency, and we are confident in the revised BLA application,” said Russell Trenary, President and CEO of Outlook Therapeutics. “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, Chief Operations Officer 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 best-in-class 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.
The BLA re-submission is based on the totality of data from Outlook Therapeutics’ wet AMD clinical program for ONS-5010, which consists of three completed registration clinical trials - NORSE ONE, NORSE TWO and NORSE THREE – as well as a Phase 1 pharmacokinetic clinical trial and the necessary pre-clinical testing.
Read the full press release from Outlook Therapeutics.
Source: Outlook Therapeutics