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Outlook Therapeutics Provides Clinical Update on ONS-5010 / LYTENAVA™ (bevacizumab-vikg)
Lead product candidate ONS-5010 / LYTENAVATM (bevacizumab-vikg) has potential to be first FDA-approved ophthalmic formulation of bevacizumab for use in
About this update from Outlook Therapeutics, Inc.
[{"type":"text","content":"Lead product candidate ONS-5010 / LYTENAVATM (bevacizumab-vikg) has potential to be first FDA-approved ophthalmic formulation of bevacizumab for use in multiple retinal indications Topline results from NORSE 1, the Company’s first registration clinical trial evaluating ONS-5010 and providing clinical experience and initial safety and efficacy data, are expected in August 2020 NORSE 2 has enrolled 204 of 220 planned patients and is expected to complete enrollment no later than August 2020 NORSE 3 open-label safety study designed to support planned BLA is expected to commence in Q4 2020 MONMOUTH JUNCTION, N.J., June 17, 2020 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK) (the Company), a late clinical-stage biopharmaceutical company working to develop the first FDA-approved ophthalmic formulation of bevacizumab for use in retinal indications, today provided a clinical update for ONS-5010 / LYTENAVA™ (bevacizumab-vikg), the Company’s investigational ophthalmic formulation of bevacizumab.\n Outlook Therapeutics is currently conducting two registration clinical trials for ONS-5010. At an End-of-Phase 2 meeting in April 2018, the U.S. Food and Drug Administration (FDA) accepted the study design / size for the NORSE 1 and NORSE 2 trials and confirmed that each of them is acceptable and may support a new biologics license application (BLA) under the 351(a) regulatory pathway toward approval for the treatment of wet age-related macular degeneration (wet AMD). “The remainder of 2020 is poised to be an exciting year for Outlook Therapeutics and ONS-5010 as we approach multiple major milestones in the coming quarter,” said Lawrence A. Kenyon, President, CEO and CFO of the Company. “The agreed-upon regulatory strategy with the FDA that includes the two registration trials provides us with a streamlined and significantly de-risked pathway towards approval. The first key milestone towards filing our new BLA begins with the topline safety and efficacy results from our NORSE 1 trial, which we expect to report in August, just two months away. This study is expected to provide us with valuable insight as to the safety of ONS-5010 dosed monthly in comparison to the PIER quarterly dosing regimen of ranibizumab. We also will be able to assess the first human efficacy data for ONS-5010 in wet AMD. Although not pivotal data, these study ...