Outlook Therapeutics announced that the FDA issued a complete response letter (CRL) to its biologics license application (BLA) resubmission for ONS-5010, targeting wet AMD.
The FDA said it could not approve the application in its current form. The CRL identified only one deficiency—lack of substantial evidence of effectiveness.
The FDA highlighted that ONS-5010 did not meet the primary efficacy endpoint in the NORSE EIGHT study. It recommended confirmatory evidence of efficacy.
The agency also reiterated that NORSE TWO met its primary endpoint for effectiveness, reinforcing mixed outcomes across different clinical trials.
Bob Jahr, CEO of Outlook Therapeutics, expressed disappointment. He said the company will meet with the FDA to clarify requirements for potential approval.
He emphasized that the CRL raised no other outstanding deficiencies in the BLA. He reaffirmed the company’s commitment to providing a safe alternative to compounded Avastin.
While addressing the FDA’s concerns, Outlook Therapeutics continues expanding in Europe. Lytenava (bevacizumab gamma) already holds Marketing Authorization in the EU and UK for wet AMD.
In June 2025, Lytenava became commercially available in Germany and the UK. It is the first and only authorized ophthalmic bevacizumab formulation for wet AMD in Europe.
Age-related macular degeneration (AMD) is a leading cause of vision loss in adults over 50. Wet AMD, its advanced form, causes severe vision impairment.
Abnormal blood vessels grow beneath the retina, leaking fluid and blood. This damages the macula, the part of the eye responsible for sharp central vision.
Anti-VEGF therapies, delivered by injection, block abnormal vessel growth. They remain the standard treatment for wet AMD and related retinal conditions, such as diabetic macular edema.
ONS-5010/Lytenava is an ophthalmic formulation of bevacizumab. It binds with high affinity to VEGF isoforms, blocking VEGF interaction with its endothelial receptors.
This mechanism reduces endothelial cell proliferation, vascular leakage, and abnormal blood vessel growth, helping preserve vision in patients with wet AMD.
In the United States, ONS-5010/Lytenava remains investigational. In Europe, additional pricing and reimbursement approvals are required before broader availability.
Outlook Therapeutics continues its mission to advance ONS-5010/Lytenava for retinal diseases. Its goal is to enhance the standard of care for bevacizumab-based therapies worldwide.
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