FDA requests more information on Outlook’s ophthalmic bevacizumab
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Outlook Therapeutics is withdrawing its biologics license application for ONS-5010 for the treatment of wet age-related macular degeneration after the FDA requested more information, according to a press release.
ONS-5010, also known as Lytenava, is an ophthalmic formulation of bevacizumab under investigation for the treatment of retinal diseases, including wet AMD. The company submitted the application in March after the completion of three clinical trials, NORSE ONE, NORSE TWO and NORSE THREE.
“We remain confident in ONS-5010 and its potential to be the first FDA-approved ophthalmic formulation of bevacizumab that avoids the public health risk to patients of off-label treatment of bevacizumab that was never approved for any ophthalmic indications,” Russell Trenary, Outlook president and CEO, said in the release. “We are continuing to have productive discussions with the FDA and are committed to providing the additional information necessary to support the application.”
The company plans to resubmit the application by September.
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