Outlook Therapeutics (NASDAQ:OTLK) received a complete response letter (CRL) to the company’s biologics license application (BLA) for ONS-5010, an investigational ophthalmic formulation of bevacizumab under development to treat wet AMD.
While the FDA acknowledged the NORSE TWO pivotal trial met its safety and efficacy endpoints, the agency concluded it could not approve the application during this review cycle due to several chemistry, manufacturing and controls issues, open observations from pre-approval manufacturing inspections, and a lack of substantial evidence.
ONS-5010 is an investigational ophthalmic formulation of bevacizumab under development as an intravitreal injection for the treatment of wet AMD and other retinal diseases.
“We will request a formal meeting as soon as possible with the FDA to further understand the BLA deficiencies and how best to resolve them,” Russell Trenary, president and CEO of Outlook, said in a statement.
“Following this meeting with the FDA, the company will be able to discuss next steps and the expected timing for resolution,” he added.
Julia Haller, M.D., ophthalmologist-in-chief at Wills Eye Hospital and an Outlook board member, said the retina community needs an FDA-approved ophthalmic bevacizumab to deliver an alternative targeted on-label treatment for patients with wet AMD.