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Outlook Therapeutics Provides Update Following Type A Meeting with FDA Regarding ONS-5010/LYTENAVA™ (bevacizumab-vikg)
ISELIN, N.J., March 05, 2026 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company focused on enhancing the standard of
About this update from Outlook Therapeutics, Inc.
[{"type":"text","content":"ISELIN, N.J., March 05, 2026 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company focused on enhancing the standard of care for bevacizumab for the treatment of retina diseases, today provided an update following its recent Type A meeting with the U.S. Food and Drug Administration (FDA) to discuss the December 30, 2025 Complete Response Letter (CRL) for the Biologics License Application (BLA) for ONS-5010/LYTENAVA™ (bevacizumab-vikg). The Type A meeting was conducted to clarify the outstanding issue identified in the CRL regarding substantial evidence of effectiveness and to discuss potential paths forward for regulatory approval. “We appreciate the FDA’s engagement during the Type A meeting and remain committed to working constructively with the Agency,” said Bob Jahr, Chief Executive Officer of Outlook Therapeutics. “Our goal is to reach alignment on the confirmatory evidence supporting our application and to identify the most efficient pathway toward potential approval.” The Company expects to continue engaging in discussions with the FDA to further clarify the Agency’s views on confirmatory evidence and the appropriate path forward. Outlook Therapeutics is evaluating the available regulatory options to advance ONS-5010/LYTENAVA™ toward potential U.S. approval. ONS-5010/LYTENAVA™ demonstrated clinically meaningful and statistically significant improvements in visual acuity in the NORSE TWO randomized, double masked, active controlled Phase 3 trial, which met its primary and key secondary endpoints. NORSE EIGHT, along with other information submitted to the BLA, demonstrated confirmatory evidence of efficacy and safety of ONS-5010 supporting the successful NORSE TWO trial, including functional and pharmacodynamic evidence consistent with the anti-VEGF mechanism of action. ONS-5010 also demonstrated a favorable safety profile, with no safety concerns identified by the FDA. If approved, ONS-5010/LYTENAVA™ would be the first FDA-approved ophthalmic formulation of bevacizumab supported by standardized manufacturing, FDA-approved labeling, and robust pharmacovigilance. The product candidate is supported by a fully domestic, end-to-end U.S. manufacturing supply chain. About ONS-5010 / LYTENAVA™ (bevacizumab-vikg, bevacizumab gamma) ONS-5010/LYTENAVA™ is an ophthalmic formulation of bevacizumab p...