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Outlook Therapeutics faces FDA hurdles for Lytenava's approval in wet AMD, seeking clarity on efficacy requirements while expanding globally.
FDA issued the CRL to the BLA resubmission indicating that FDA cannot approve Lytenava in its present form.
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Outlook Therapeutics announced that FDA has issued a complete response letter (CRL) to its biologics license application (BLA) resubmission, suggesting that Lytenava cannot be approved in its current form for treatment of wet age-related macular degeneration (wet AMD).
“While we are very disappointed with this outcome, we intend to meet with the FDA to receive additional clarity on their requirements to potentially approve the first on-label bevacizumab product specifically formulated, manufactured, and packaged for intravitreal use in the United States. We remain committed to providing patients with a safe and effective alternative to compounded Avastin manufactured in the United States,” commented Bob Jahr, chief executive officer of Outlook Therapeutics. “It is important to also note that the CRL identified no other outstanding deficiencies in our BLA.”1
The CRL for Lytenava only included one deficiency: a lack of substantial evidence of effectiveness. Additionally, the CRL advises for the submission of confirmatory evidence of efficacy to support Lytenava’s submission due to the treatment not reaching its primary efficiency endpoint in Norse Eight, yet achieving the primary efficiency endpoint it in Norse Two.
Outlook elected to request a meeting with FDA to discuss pathways of potential approval within the U.S., while also continuing to expand its efforts into additional markets worldwide, such as in Europe. Previously announced, Lytenava received authorization for marketing approval by the European Commission in the EU, along with marketing authorization by the Medicines and Healthcare products Regulatory Agency (MHRA) in the U.K. for the treatment of wet MD.
Outlook’s management team also hosted a corporate update conference call and webcast, for interested participants and investors to discuss plans and actions for Outlook and Lytenava’s next steps in its process.
Back in April of this year, Outlook issued a resubmission to FDA of Lytenava’s BLA, which was accepted with a Prescription Drug User Fee Act (PDUFA) goal date set for August 27 of this year. FDA determined the resubmission was a Class 2 review. Lawernce Kenyon, chief financial officer and interim CEO of Outlook, commented at the time, “Our team has worked diligently to advance our development and regulatory strategies for ONS-5010 to get to this point, and we are proud of the continued progress we have been able to achieve. This BLA acceptance and PDUFA date are significant milestones in our continued mission to offer clinicians and their patients the first and only on-label, ophthalmic bevacizumab to treat wet AMD. We are committed to bringing an ophthalmic bevacizumab to market in the U.S. and are continuing our activities for potential commercialization.”2
Lytenava (ONS-5010), an ophthalmic formulation of bevacizumab for the treatment of wet AMD in the UK and European Union however, in the United States Lytenava is still currently investigational. If Lytenava receives FDA approval within the U.S., it would mark the first approved ophthalmic formulation of bevacizumab for use in retinal indications, including for the treatment of wet AMD.
In June 2025, Lytenava (bevacizumab gamma) became commercially available in Germany and the UK for the treatment of wet AMD. Lytenava also became the first authorized ophthalmic formulation of bevacizumab for use in treating wet AMD in adults in the European Union, and in the UK.1 In certain European Union Member States, however, Lytenava must still receive pricing and reimbursement approval before it can be sold.
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