Core Insights - Opthea Limited is preparing for an Investor Day on January 28, 2025, in New York City, followed by presentations in Sydney and Melbourne, to discuss the anticipated topline data from its pivotal trials for sozinibercept in wet AMD [1][2][3] Company Overview - Opthea is a clinical-stage biopharmaceutical company focused on developing novel therapies for retinal diseases, particularly wet age-related macular degeneration (wet AMD) and diabetic macular edema (DME) [8][9] - The lead product candidate, sozinibercept, is currently being evaluated in two pivotal Phase 3 clinical trials (COAST and ShORe) aimed at improving efficacy and vision outcomes when used in combination with standard anti-VEGF-A therapies [9] Management and Expertise - The Investor Day will feature presentations from Charles C. Wykoff, MD, PhD, a leading retina specialist and Chief Investigator for the COAST trial, and Mike Campbell, Chief Commercial Officer, who has extensive experience in launching treatments for retinal diseases [4][5][6] Event Details - The New York event will include a live webcast and a question-and-answer session, concluding around 3:00 PM ET, with a replay available on the company's website [2] - In-person presentations will also take place in Sydney on February 3 and Melbourne on February 5, 2025 [3]

Phase 1b clinical data underpins sozinibercept's potential as a novel, first-in-class VEGF-C/D ‘trap' to improve visual and anatomic outcomes in DME Published in peer-reviewed journal Translational Vision Science & Technology and included in the Anti-VEGF Special Journal Issue of ARVO DME program to be advanced after wet AMD topline data readout anticipated for COAST in early CY Q2 2025 and ShORe in mid-2025 MELBOURNE, Australia and PRINCETON, N.J., Jan. 07, 2025 (GLOBE NEWSWIRE) -- Opthea Limited (NASDAQ:O ...

Business update to include masked Phase 3 patient demographics and baseline characteristics Presentation on Wednesday, January 15, 2025, 5:15 PM PT in San Francisco, California MELBOURNE, Australia and PRINCETON, N.J., Dec. 19, 2024 (GLOBE NEWSWIRE) -- Opthea Limited (NASDAQ:OPT, "Opthea", the "Company")), a clinical-stage biopharmaceutical company developing novel therapies to treat highly prevalent and progressive retinal diseases, including wet age-related macular degeneration (wet AMD), today announced ...

MELBOURNE, Australia, and Princeton, N.J., Nov. 26, 2024 (GLOBE NEWSWIRE) -- Opthea Limited (ASX/NASDAQ:OPT, “Opthea”, the “Company”), a clinical-stage biopharmaceutical company developing novel therapies to treat highly prevalent and progressive retinal diseases, including wet age-related macular degeneration (wet AMD), today announced that sozinibercept will be featured as part of an oral presentation at the annual FLORetina Congress being held on December 5-8, 2024 in Florence, Italy. FLORetina aims to p ...

Ms. Connell is a commercial executive with business development expertise Appointment takes place as Opthea prepares for Phase 3 wet AMD topline data in 2025 MELBOURNE, Australia, and PRINCETON, N.J., Nov. 15, 2024 (GLOBE NEWSWIRE) -- Opthea Limited (ASX/NASDAQ: OPT, “Opthea”, the “Company”), a clinical-stage biopharmaceutical company developing novel therapies to treat highly prevalent and progressive retinal diseases, including wet age-related macular degeneration (wet AMD), today announced the appointme ...

Core Insights - Opthea Limited has successfully completed its drug substance Process Performance Qualification (PPQ) campaign for sozinibercept, a significant step towards a potential biologics license application (BLA) filing for the treatment of wet age-related macular degeneration (wet AMD) [1][2] - The completion of the PPQ campaign involved the production of three consecutive commercial-scale drug substance batches, validating Opthea's manufacturing process [1][2] - The company is advancing two pivotal Phase 3 trials of sozinibercept, demonstrating its capability to consistently manufacture quality drug substance at a commercial scale, which is crucial for the BLA Chemistry, Manufacturing and Controls (CMC) module [2][4] Company Overview - Opthea is a clinical-stage biopharmaceutical company focused on developing novel therapies for retinal diseases, including wet AMD and diabetic macular edema (DME) [3] - The lead product candidate, sozinibercept, is being evaluated in two fully enrolled pivotal Phase 3 clinical trials aimed at improving efficacy and vision gains compared to standard anti-VEGF-A agents [4]

MELBOURNE, Australia and PRINCETON, N.J., Sept. 10, 2024 (GLOBE NEWSWIRE) -- Opthea Limited (ASX/NASDAQ: OPT, "Opthea", the "Company"), a clinical-stage biopharmaceutical company developing novel therapies to treat highly prevalent and progressive retinal diseases, including wet age-related macular degeneration (wet AMD), today announced scientific presentations and a non-CME educational lunch symposium highlighting sozinibercept's potential to become the first therapy in 20 years to improve visual outcomes ...

MELBOURNE, Australia and PRINCETON, N.J., Sept. 03, 2024 (GLOBE NEWSWIRE) -- Opthea Limited (ASX/NASDAQ: OPT, "Opthea", the "Company"), a clinical-stage biopharmaceutical company developing novel therapies to treat highly prevalent and progressive retinal diseases, including wet age-related macular degeneration (wet AMD), today announced that management will present and participate in one-on-one investor meetings at the following two investor conferences in September 2024: H.C. Wainwright 26th Annual Global ...

Completed patient enrollment in COAST and ShORe pivotal wet AMD trials Financings extended cash runway through topline data readout of both trials in CY2025 Leadership appointments in preparation for regulatory filing and launch of sozinibercept MELBOURNE, Australia, and PRINCETON, N.J., Aug. 30, 2024 (GLOBE NEWSWIRE) -- Opthea Limited (ASX/NASDAQ: OPT, "Opthea", the "Company"), a clinical-stage biopharmaceutical company developing novel therapies to treat highly prevalent and progressive retinal diseases, ...

MELBOURNE, Australia and PRINCETON, N.J., Aug. 08, 2024 (GLOBE NEWSWIRE) -- Opthea Limited (ASX/NASDAQ: OPT, "Opthea", the "Company"), a clinical-stage biopharmaceutical company developing novel therapies to treat highly prevalent and progressive retinal diseases, including wet age-related macular degeneration (wet AMD), today announced that management will present at the H.C. Wainwright 4th Annual Ophthalmology Virtual Conference and participate in one-on-one investor meetings on August 15, 2024. Virtual C ...