Outlook Therapeutics, Inc. today announced the completion of its Type A Meeting with the U.S. Food and Drug Administration (FDA) to discuss the Complete Response Letter (CRL) for the ONS-5010 Biologics License Application (BLA) resubmission. The meeting focused on clarifying the confirmatory evidence of efficacy required by the FDA.
Based on the discussions, Outlook Therapeutics expects to resubmit its BLA before the end of calendar year 2025, pending the review of the agency’s feedback and meeting minutes. This indicates a defined path forward for ONS-5010 in the U.S. market.
Bob Jahr, Chief Executive Officer, stated that the company had a productive discussion with the FDA and remains committed to providing a safe and effective ophthalmic bevacizumab for wet AMD to patients, physicians, and payers in the U.S.
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