Outlook Therapeutics has received the US Food and Drug Administration’s (FDA) complete response letter (CRL) regarding the biologics licence application (BLA) resubmission for ONS-5010/LYTENAVA (bevacizumab-vikg) to treat wet age-related macular degeneration (wet AMD).
The FDA stated it cannot approve the application in its current form and requested confirmatory further evidence of efficacy, without specifying the type of evidence required.
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In the CRL, it noted that additional mechanistic and natural history data submitted with the BLA did not change its prior review conclusion, while one adequate and well-controlled study showed efficacy.
The BLA resubmission for ONS-5010 was supported by data from the NORSE clinical trial programme, including the pivotal NORSE TWO trial and confirmatory safety and efficacy data from other NORSE studies.
These included NORSE EIGHT, a non-inferiority study comparing ONS-5010 and ranibizumab in a 12-week trial of treatment-naïve patients, with the primary efficacy endpoint at eight weeks. The company maintains that this data set supports the case for US approval.
Outlook Therapeutics is evaluating all potential pathways for approval in the US and continues efforts to expand in Europe and other regions.
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By GlobalDataLYTENAVA (bevacizumab gamma) has marketing authorisation from the European Commission in the EU and the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK for wet AMD treatment.
Outlook Therapeutics CEO Bob Jahr said: “Our goal has always been to provide wet AMD patients and their physicians with a safe, consistent, FDA-approved alternative to compounded Avastin manufactured in the US, and that goal has not changed.
“We are disappointed and disagree with this decision, but we remain fully committed to taking all necessary steps to receive approval in the US. We continue to believe strongly in the clinical need and commercial potential of the first on-label bevacizumab product for patients in the US that is specifically formulated, manufactured, and packaged for intravitreal use.”
In November 2024, Outlook Therapeutics’ second attempt to obtain US approval for its wet AMD therapy, Lytenava, suffered a setback as the therapy failed to meet a key endpoint in the Phase III NORSE EIGHT trial.
