Core Viewpoint - Outlook Therapeutics is focusing on the commercial launch of LYTENAVA™ (bevacizumab gamma) for wet age-related macular degeneration (wet AMD) in the EU and UK, while also preparing to resubmit its Biologics License Application (BLA) for ONS-5010 in the U.S. following a strategic review to streamline operations and reduce costs [1][2]. Company Initiatives - The management team has implemented initiatives to streamline the organization, reduce operating expenses, and preserve capital, aiming to maximize efforts for the commercial launch of LYTENAVA™ [1][2]. - A 23% reduction in workforce has been announced, which is expected to save approximately $1.4 million annually, excluding the costs associated with the workforce reduction [2]. Regulatory Approvals - LYTENAVA™ has received Marketing Authorization from the European Commission in the EU and the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK, making it the first authorized ophthalmic formulation of bevacizumab for treating wet AMD [2][5]. - The National Institute for Health and Care Excellence (NICE) has recommended LYTENAVA™ as a treatment option for wet AMD [2]. Clinical Trials and Future Plans - The company plans to resubmit its BLA for ONS-5010 in the first quarter of 2025, pending the full efficacy and safety results from the NORSE EIGHT clinical trial expected in January 2025 [2][6]. - Preliminary data from the NORSE EIGHT trial indicated an improvement in vision and a favorable safety profile for ONS-5010, despite not meeting the pre-specified non-inferiority endpoint [2][6]. Product Overview - ONS-5010/LYTENAVA™ is a recombinant humanized monoclonal antibody designed to treat wet AMD by neutralizing vascular endothelial growth factor (VEGF) [4][5]. - If approved in the U.S., ONS-5010/LYTENAVA™ would be the first approved ophthalmic formulation of bevacizumab for retinal indications, including wet AMD [6].

ISELIN, N.J., Dec. 03, 2024 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company that achieved regulatory approval in the European Union and the United Kingdom earlier this year for LYTENAVA™ (bevacizumab gamma), the first ophthalmic formulation of bevacizumab authorized for the treatment of wet age-related macular degeneration (wet AMD) in adults, today announced that Russell Trenary has stepped down as the Company’s President and Chief Executive Officer (CEO), effecti ...

NEW YORK, Dec. 2, 2024 /PRNewswire/ -- Pomerantz LLP is investigating claims on behalf of investors of Outlook Therapeutics, Inc. ("Outlook" or the "Company") (NASDAQ: OTLK).  Such investors are advised to contact Danielle Peyton at [email protected] or 646-581-9980, ext. 7980.The investigation concerns whether Outlook and certain of its officers and/or directors have engaged in securities fraud or other unlawful business practices. [Click here for information about joining the class action] On November 27, ...

Core Viewpoint - Outlook Therapeutics' ONS-5010 (Lytenava) failed to meet the non-inferiority endpoint in the NORSE EIGHT clinical study for treating wet age-related macular degeneration (AMD), leading to a significant drop in share price by 65.2% [2][5] Company Summary - The NORSE EIGHT study involved newly diagnosed wet AMD patients receiving either 1.25 mg ONS-5010 or 0.5 mg Lucentis (ranibizumab) through intravitreal injections, with the primary endpoint being the mean change in best-corrected visual acuity from baseline to week eight [3] - Despite the failure to meet the primary endpoint, ONS-5010 showed vision improvement, biological activity, and a favorable safety profile, with ocular adverse event rates comparable to Lucentis [4] - Further analysis of the study data is ongoing, with full results expected in January 2025, and the company plans to resubmit the biologics license application (BLA) for ONS-5010 in Q1 2025 [5] Regulatory and Market Context - In August 2023, Outlook Therapeutics received a complete response letter (CRL) from the FDA regarding the BLA for ONS-5010, citing concerns related to chemistry, manufacturing, and controls [7][8] - The company has addressed the issues raised by the FDA and received regulatory approval for ONS-5010 in the EU and the U.K. for treating wet AMD, with plans to launch in 2025 [10][11] - ONS-5010 is positioned as a regulated alternative to off-label repackaged Avastin (bevacizumab), which is not approved for ophthalmic use [11]

Outlook Therapeutics Inc. OTLK revealed preliminary topline results of NORSE EIGHT, the second of two clinical trials evaluating ONS-5010 in wet AMD patients.In the NORSE EIGHT trial, ONS-5010 did not meet the pre-specified noninferiority endpoint at week 8 set forth in the special protocol assessment (SPA) with the FDA.The pre-specified noninferiority endpoint was measured by mean change in best corrected visual acuity (BCVA) from baseline to week 8.Also Read: Why Is Eye Disease-Focused Outlook Therapeutic ...

Final efficacy data expected in January 2025Anticipate resubmission of BLA in calendar Q1 2025 ISELIN, N.J., Nov. 27, 2024 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company that achieved regulatory approval in the European Union and the United Kingdom earlier this year for the first authorized use of an ophthalmic formulation of bevacizumab for the treatment of wet age-related macular degeneration (wet AMD), today announced preliminary topline results of NORSE EIGHT, ...

ISELIN, N.J., Nov. 06, 2024 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company that achieved regulatory approval in the European Union and the United Kingdom earlier this year for the first authorized use of an ophthalmic formulation of bevacizumab for the treatment of wet age-related macular degeneration (wet AMD), today announced that Russell Trenary, President and CEO of Outlook Therapeutics will participate in a fireside chat on Tuesday, November 12, 2024 at 2:30 ...

ISELIN, N.J., Sept. 16, 2024 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company that achieved regulatory approval in the European Union and the United Kingdom earlier this year for the first authorized use of an ophthalmic formulation of bevacizumab for the treatment of wet age-related macular degeneration (wet AMD), today announced that Russell Trenary, President and CEO of Outlook Therapeutics will participate in the Virtual Investor Closing Bell Series on Thursday, ...

Group 1 - Outlook Therapeutics, Inc. has received regulatory approval in the European Union and the United Kingdom for the first authorized ophthalmic formulation of bevacizumab for treating wet age-related macular degeneration (wet AMD) [1][4] - The company participated in the 2nd Annual Chardan Virtual Ophthalmology Conference, focusing on age-related macular degeneration and diabetes-related ocular diseases, alongside seven other companies [2] - The commercial launch of LYTENAVA™ (bevacizumab gamma) in the EU and the UK is expected in the first half of calendar 2025 [4] Group 2 - ONS-5010/LYTENAVA™ is currently investigational in the United States and is undergoing a non-inferiority study for wet AMD treatment [4] - If the ongoing study is successful, the data may support a resubmission of a Biologics License Application (BLA) to the FDA [4] - If approved in the United States, ONS-5010/LYTENAVA™ would be the first approved ophthalmic formulation of bevacizumab for retinal indications, including wet AMD [4]

Topline results from NORSE EIGHT expected in Q4 CY2024 ISELIN, N.J., Sept. 04, 2024 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company that achieved regulatory approval in the European Union and the United Kingdom earlier this year for the first authorized use of an ophthalmic formulation of bevacizumab for the treatment of wet age-related macular degeneration (wet AMD), today announced the completion of enrollment for its NORSE EIGHT clinical trial evaluating ONS-501 ...