FDA Rejects Lytenava by Outlook Therapeutics for Wet AMD

Outlook Therapeutics announced that the FDA has issued a complete response letter (CRL) regarding the company's Biologics License Application (BLA) for ONS-5010 (Lytenava). ONS-5010 is an investigative ophthalmic formulation of bevacizumab aimed at treating wet AMD.

While the FDA recognized the successful fulfillment of safety and efficacy benchmarks in the NORSE TWO pivotal trial, Outlook indicated that, within this evaluation phase, the FDA could not grant approval for the BLA due to 'several CMC issues, open observations from preapproval manufacturing inspections, and a lack of substantial evidence.'

“We continue to believe in the public health need to provide the retina community with an FDA-approved bevacizumab treatment option for wet AMD. 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. Following this meeting with the FDA, the company will be able to discuss next steps and the expected timing for resolution,” Russell Trenary, President and CEO of Outlook Therapeutics, said in a company news release.

During an investor conference call on Wednesday morning, Mr. Trenary communicated that the company intends to request a Type A meeting with the FDA. The purpose of this meeting is to engage in further discussions about the concerns outlined in the CRL and the necessary steps to reach a resolution.

This represents the second setback encountered by Outlook. In May 2022, the company made a voluntary decision to withdraw its Biologics License Application (BLA) for ONS-5010. This move followed the FDA's request for additional information to supplement the BLA filing. Subsequently, in August 2022, the company resubmitted the application after asserting that the requested supplemental information had been provided to the FDA.

ONS-5010 is currently being developed as an investigational ophthalmic formulation of bevacizumab, intended for intravitreal injection. Its purpose is to address wet AMD and other retinal diseases. If granted approval, ONS-5010 would present a sanctioned option for physicians who presently prescribe unapproved, reconfigured oncologic IV bevacizumab obtained from compounding pharmacies for treating wet AMD.

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