Outlook Therapeutics Resubmits Biologics License Application for ONS-5010 Ophthalmic Bevacizumab Formulation.
ByAinvest
Monday, Nov 3, 2025 8:37 am ET1min read
OTLK--
Outlook Therapeutics has resubmitted its Biologics License Application (BLA) to the FDA for ONS-5010, a bevacizumab formulation for wet age-related macular degeneration (AMD). The resubmission addresses outstanding issues highlighted in the Complete Response Letter received in August 2025. The company is accelerating commercial efforts in Europe and positioning for potential near-term US approval.
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