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Outlook Therapeutics Reports Financial Results for Fiscal Year 2020 and Provides Corporate Update
All planned clinical trials for ONS-5010 / LYTENAVA™ (bevacizumab-vikg) wet AMD BLA now fully enrolled or completedPivotal data expected in mid-2021 from
About this update from Outlook Therapeutics, Inc.
[{"type":"text","content":"All planned clinical trials for ONS-5010 / LYTENAVA™ (bevacizumab-vikg) wet AMD BLA now fully enrolled or completedPivotal data expected in mid-2021 from ongoing, fully enrolled Phase 3 registration trial for ONS-5010 (NORSE TWO) with new BLA filing expected in second half of 2021 MONMOUTH JUNCTION, N.J., Dec. 23, 2020 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a late clinical-stage biopharmaceutical company working to develop the first FDA-approved ophthalmic formulation of bevacizumab-vikg for use in retinal indications, today announced its corporate highlights and financial results for its fiscal year ended September 30, 2020. Outlook Therapeutics also provided a clinical development and pre-commercialization update on ONS-5010 / LYTENAVA™ (bevacizumab-vikg), its investigational ophthalmic formulation of bevacizumab-vikg for the treatment of wet age-related macular degeneration (wet AMD) and other retinal indications. “2020 has been a pivotal year for Outlook Therapeutics. Not only have we continued to make significant progress with our pre-commercialization activities in anticipation of our planned BLA filing for ONS-5010 to treat wet AMD in 2021, but all of our planned clinical trials for this indication also have either been completed or achieved full enrollment,” commented Lawrence A. Kenyon, President, CEO and CFO of Outlook Therapeutics. “In the near-term, we are focused on the successful completion and data readout for the pivotal Phase 3 study in the third calendar quarter of 2021 followed by our planned BLA submission. Beyond that, we are also engaged with regulatory authorities in Europe for anticipated submissions in those markets, plus we are planning to initiate registration clinical trials for ONS-5010 for DME and BRVO later in 2021.” 2020 Corporate Highlights Reported topline results demonstrating anticipated safety and efficacy and positive proof-of-concept of ONS-5010 / LYTENAVA™ from the NORSE ONE clinical experience trial, the first of two required registration clinical trials;Completed patient enrollment for the NORSE TWO pivotal registration study evaluating ONS-5010 / LYTENAVA™, the second of two required registration clinical trials;Completed patient enrollment for the NORSE THREE open-label safety study for ONS-5010 / LYTENAVA™ ahead of schedule;Successfully completed technology tra...