Business
Outlook Therapeutics Announces Formal Dispute Resolution Request for ONS-5010/LYTENAVA™ (bevacizumab-vikg) Accepted by FDA
ISELIN, N.J., April 07, 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., April 07, 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 announced that it submitted a formal dispute resolution request (FDRR) to the U.S. Food and Drug Administration (FDA) as a follow-up to its recent Type A meeting regarding the December 30, 2025 Complete Response Letter (CRL) for the Biologics License Application (BLA) for ONS-5010/LYTENAVA™ (bevacizumab-vikg) for the treatment of neovascular age-related macular degeneration. The FDA has accepted the FDRR and has granted a meeting with the deciding official to be conducted in April 2026. Subsequent to receiving the CRL in December 2025, Outlook Therapeutics has engaged with the FDA on multiple occasions, including a formal Type A meeting on March 2, 2026, which led to the submission of the FDRR and associated meeting. “We look forward to our discussions with the FDA and remain committed to our position that data on safety and efficacy for LYTENAVA demonstrated in NORSE TWO and NORSE EIGHT provide sufficient evidence to support approval and bring a much-needed FDA approved option for patients,” said Bob Jahr, Chief Executive Officer of Outlook Therapeutics. The Company’s submission includes a comprehensive presentation of the existing clinical, functional, and pharmacodynamic data, and safety findings, which Outlook Therapeutics believes collectively support the efficacy and safety of ONS-5010/LYTENAVA™ for the treatment of neovascular age-related macular degeneration. Outlook Therapeutics will continue to work collaboratively with the FDA throughout the formal dispute resolution process and will provide updates as appropriate. 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. Additional evidence from NORSE EIGHT and other data submitted in the BLA further support the efficacy and safety profile of ONS-5010, consistent with its anti-VEGF mechanism of action. No safety concerns have been raised by the FDA. If approved, ONS-5010/LYTENAVA™ would be the first FDA-approved ophthalmic formulation of bevacizumab supported by standa...