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Outlook Therapeutics Provides Update on Type A Meeting with FDA
ISELIN, N.J., Sept. 29, 2025 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company focused on optimizing the standard of care for bevacizumab for the treatment of retina diseases, today announced that it has completed the Type A Meeting with the U.S. Food and Drug Administration (FDA) to discuss the complete response letter (CRL) dated August 27, 2025 regarding the biologics license application (BLA) resubmission for ONS-5010, an investigational ophthalmic fo
About this update from Outlook Therapeutics, Inc.
[{"type":"image","alt":"Outlook Therapeutics, Inc.","displaySize":"","headline":null,"caption":"Outlook Therapeutics, Inc.","className":"","disableSlideshowImg":false,"size":{"original":{"width":300,"height":80,"url":"https://media.zenfs.com/en/globenewswire.com/036f630f46be050c02b981afef3ca9e4"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/qNsjgbA2tq9jniYix8cXEg--/YXBwaWQ9aGlnaGxhbmRlcjt3PTQyMDtoPTExMjtjZj13ZWJw/https://media.zenfs.com/en/globenewswire.com/036f630f46be050c02b981afef3ca9e4","width":300,"height":80}},"lazy":false},{"type":"text","content":"ISELIN, N.J., Sept. 29, 2025 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company focused on optimizing the standard of care for bevacizumab for the treatment of retina diseases, today announced that it has completed the Type A Meeting with the U.S. Food and Drug Administration (FDA) to discuss the complete response letter (CRL) dated August 27, 2025 regarding the biologics license application (BLA) resubmission for ONS-5010, an investigational ophthalmic formulation of bevacizumab under development to treat wet AMD. Based on the discussion with the FDA, Outlook Therapeutics expects to resubmit its BLA before the end of calendar year 2025, after reviewing the agency’s feedback and meeting minutes.","length":750,"tagName":"p"},{"type":"text","content":"“We had a productive discussion with the FDA. Based on our meeting, and pending receipt of the agency’s written minutes, we plan to resubmit the BLA later this year. We remain committed to providing patients, physicians and payors in the U.S. with a safe and effective ophthalmic bevacizumab for the treatment of wet AMD,” commented Bob Jahr, Chief Executive Officer of Outlook Therapeutics.","length":396,"tagName":"p"},{"type":"text","content":"About ONS-5010/LYTENAVA™ (bevacizumab-vikg, bevacizumab gamma)","length":62,"tagName":"p"},{"type":"text","content":"ONS-5010/LYTENAVA™ is an ophthalmic formulation of bevacizumab for the treatment of wet AMD. LYTENAVA™ (bevacizumab gamma) is the subject of a centralized Marketing Authorization granted by the European Commission in the EU and Marketing Authorization granted by the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK for the treatment of wet AMD.","length":365,"tagName":"p"},{"type":"text","content":"In the United States, ONS-5010/L...