FDA does not approve biologics license application for ONS-5010 for wet AMD treatment
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Key takeaways:
- The FDA issued a complete response letter for ONS-5010.
- Causes for the rejection include chemistry, manufacturing and controls issues, and a lack of clinical evidence supporting ONS-5010.
The FDA issued a complete response letter noting its rejection of the biologics license application for ONS-5010 for the treatment of wet age-related macular degeneration, according to a press release from Outlook Therapeutics.
“Clearly, we are disappointed and hope to work with the agency to find a path forward for re-submission and eventual approval of ONS-5010,” Russell Trenary, president and CEO of Outlook Therapeutics, told Healio.
The FDA did not approve the biologics license application (BLA) for ONS-5010/Lytenava (bevacizumab-vikg) due to “several CMC [chemistry, manufacturing and controls] issues, open observations from pre-approval manufacturing inspections and a lack of substantial evidence,” Outlook Therapeutics said in the release, despite the phase 3 NORSE TWO clinical trial investigating the ophthalmic solution previously meeting both its safety and efficacy endpoints.
ONS-5010 is a recombinant humanized monoclonal antibody designed to reduce endothelial cell proliferation, vascular leakage and new blood vessel formation in the retina after intravitreal injection by blocking the interaction of VEGF with its receptors on the surface of endothelial cells.
“We are putting together the documents necessary to request a Type A meeting with the FDA so that we can understand more fully what we need to accomplish before we can resubmit the BLA for ONS-5010,” Trenary said. “We continue to feel strongly that the public health needs and clinical benefits of an FDA-approved ophthalmic formulation of bevacizumab are needed and desired by the retina community.”
Editor’s note: This article was updated on September 1, 2023, to include comments from Russell Trenary.
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