Outlook Therapeutics announced that the FDA declined to approve its investigational eye therapy, designed to treat wet age-related macular degeneration (wet AMD). The agency issued a Complete Response Letter (CRL), citing the need for additional clinical trial data before granting approval.
The drug, branded as ONS-5010, had been positioned as the first ophthalmic formulation of bevacizumab specifically developed for retinal indications, an area where off-label cancer drugs are commonly repurposed. Outlook Therapeutics argued its formulation could bring consistency, safety, and regulatory oversight to an existing treatment practice.
However, the FDA determined that current trial results were insufficient to establish effectiveness and requested further clinical evidence to support the therapy’s approval. While the CRL did not raise major safety concerns, efficacy data gaps left the agency unconvinced.
Company executives said they plan to meet with regulators to outline next steps, which could include an additional pivotal study. The decision delays Outlook’s plans to enter a competitive multi-billion-dollar eye care market currently dominated by established biologics such as Lucentis and Eylea. Investors reacted negatively to the announcement, sending the company’s shares lower.
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