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The company successfully appealed a 2025 complete response letter for ONS-5010 (bevacizumab-vikg, bevacizumab gamma), also known as Lytenava, and the FDA confirmed that effectiveness of the treatment has been established and that no additional trials are required. The BLA has been labeled as a class 1 resubmission, and a PDUFA date is expected within 60 days of the FDA receiving the resubmission.
ONS-5010 would be the first approved bevacizumab ophthalmic formulation, according to the release.
“This resubmission