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Outlook Therapeutics® Re-Submits Biologics License Application for ONS-5010 as a Treatment for Wet AMD to the U.S. Food and Drug Administration
ISELIN, N.J., Feb. 28, 2025 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company that achieved regulatory approval in the European Union (EU) and the United Kingdom (UK) for the first authorized use of an ophthalmic formulation of bevacizumab for the treatment of wet age-related macular degeneration (wet AMD), today announced it has re-submitted its Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for ONS-5010, an investigat
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., Feb. 28, 2025 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company that achieved regulatory approval in the European Union (EU) and the United Kingdom (UK) for the first authorized use of an ophthalmic formulation of bevacizumab for the treatment of wet age-related macular degeneration (wet AMD), today announced it has re-submitted its Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for ONS-5010, an investigational ophthalmic product which, if approved, will be branded as LYTENAVA™ (bevacizumab-vikg) for the treatment of wet age-related macular degeneration (wet AMD).","length":661,"tagName":"p"},{"type":"text","content":"“We remain committed to bringing an ophthalmic bevacizumab to market in the United States and providing retina patients suffering from wet AMD with a much needed treatment option that has the potential to address the problems associated with unapproved repackaged bevacizumab. Our team has worked diligently to address the FDA’s requests and we believe this resubmission provides the necessary evidence to support approval of the ONS-5010 BLA in the United States,” commented Lawrence Kenyon, Chief Financial Officer and Interim Chief Executive Officer of Outlook Therapeutics. “This resubmission marks a very significant milestone and puts us another step closer to a transformed Outlook Therapeutics.”","length":703,"tagName":"p"},{"type":"text","content":"The ONS-5010 BLA resubmission is based on the efficacy and safety demonstrated in NORSE EIGHT, as well as additional chemistry, manufacturing and controls (CMC) information requested by the FDA. As previously announced, following Type A meetings with the FDA in Q4 CY2023 to address the ONS-5010 Complete Response Letter (CRL), the FDA informed Outlook...