Welcome to our dedicated page for Opthea news (Ticker: OPT), a resource for investors and traders seeking the latest updates and insights on Opthea stock.
Opthea Limited (symbol: OPT) is a pioneering Australian biotechnology company dedicated to developing innovative biologic therapies for eye diseases. With a strong focus on medical technology and healthcare, Opthea's primary mission is to address unmet medical needs through advanced therapeutic solutions.
Opthea's flagship product, OPT-302, is a groundbreaking biologic treatment designed to inhibit VEGF-C and VEGF-D, which are critical factors in abnormal blood vessel growth and leakage. These mechanisms are commonly associated with eye conditions such as wet age-related macular degeneration (wet AMD). Currently, OPT-302 is undergoing a Phase 1/2a clinical trial to evaluate its safety and efficacy in patients suffering from wet AMD, marking a significant milestone in the company's development pipeline.
The company's robust intellectual property portfolio underpins its research and development efforts, covering essential targets like VEGF-C, VEGF-D, and VEGF Receptor-3. These assets form the foundation of Opthea's strategy to develop advanced treatments aimed at reducing vascular leakage and managing diseases linked to blood and lymphatic vessel growth.
Recent achievements underscore Opthea's commitment to advancing its clinical programs. The company has launched a fully underwritten Retail Entitlement Offer, inviting eligible retail shareholders in Australia and New Zealand to participate. This initiative is part of Opthea's broader strategy to secure funding and support the continued development of OPT-302.
Participants in the Placement and Entitlement Offer will receive new options, each exercisable at A$0.80, set to expire on 31 August 2025. These options are expected to be quoted on the ASX, providing additional investment opportunities for shareholders.
Investment in biotechnology firms like Opthea entails inherent risks, including the lengthy clinical trial process, patent protection uncertainties, and rapid technological advancements. However, Opthea's focused approach and strategic partnerships position it as a promising player in the biotech space. For detailed information on participation and investment opportunities, refer to the Prospectus available on the ASX website and Opthea's official site.
For more updates and information, investors and media can contact:
Media: Hershel Berry (hberry@bplifescience.com)
Investor: PJ Kelleher (pkelleher@lifesciadvisors.com)
Opthea (ASX/NASDAQ: OPT) has published Phase 2b trial data for sozinibercept in the peer-reviewed journal Ophthalmic Surgery, Lasers and Imaging Retina. The study analyzed predictors of response to sozinibercept combination therapy with ranibizumab in treatment-naïve wet AMD patients.
Key findings revealed that in patients with occult and minimally classic lesions excluding RAP (73% of study population), the combination therapy showed a statistically significant 5.7 letter improvement in best corrected visual acuity compared to ranibizumab alone. These patients also demonstrated higher rates of ≥15 letter gains and improved retinal anatomy with reduced CNV area at week 24.
The company's ongoing Phase 3 trials, COAST and ShORe, have been designed based on these findings, with topline data expected in early Q2 CY 2025 and mid-CY 2025, respectively. Wet AMD affects approximately 3.5 million people in the US and Europe, with many patients still not achieving optimal vision outcomes with current anti-VEGF-A therapies.
Opthea (ASX/NASDAQ: OPT) reported its financial results for the six months ended December 31, 2024. The company maintains a strong cash position of $131.9M, sufficient to fund operations through anticipated Phase 3 trial readouts. Key upcoming milestones include topline results from COAST trial in early Q2 2025 and ShORe trial in mid-2025, followed by BLA submission in 1H 2026.
The company reported a net loss of $131.9M compared to $101.7M in the prior year period, with operating expenses of $85.3M. The increased loss includes $26.7M in fair value of investor options and $11.7M in interest expense. Recent corporate developments include completion of Drug Product PPQ campaign, key executive appointments, and joining the S&P/ASX 300 Index.
Opthea (OPT) has successfully completed its drug product Process Performance Qualification (PPQ) campaign for sozinibercept, achieving production of three consecutive commercial-scale drug product batches. This milestone follows the drug substance PPQ campaign completion announced in September 2024 and supports the company's potential biologics license application (BLA) filing in the first half of 2026.
The company is developing sozinibercept for treating wet age-related macular degeneration (wet AMD). Phase 3 clinical trials are ongoing with topline data expected from the COAST study in early Q2 2025 and the ShORe study in mid-2025. This manufacturing achievement demonstrates Opthea's capability to produce quality drug product at commercial scale, positioning the company for potential approval and launch of sozinibercept in wet AMD.
Opthea (ASX/NASDAQ:OPT) has completed the final week 52 patient visit in COAST, one of two Phase 3 pivotal trials evaluating sozinibercept for wet age-related macular degeneration (wet AMD) treatment. The COAST trial investigates the superiority and safety of sozinibercept combined with aflibercept, while the ShORe trial studies its combination with ranibizumab.
Topline results are expected in early Q2 CY25 for COAST and mid-CY25 for ShORe. The primary endpoint for both trials measures the mean change in Best Corrected Visual Acuity from baseline to week 52. Patients will continue treatment for an additional year to evaluate extended safety and tolerability. The Phase 3 program aims to support a broad label for sozinibercept's use with any anti-VEGF-A therapy in wet AMD patients. The drug has received Fast Track Designation from the US FDA.
Opthea (ASX/NASDAQ:OPT), a clinical-stage biopharmaceutical company focused on developing novel therapies for retinal diseases including wet age-related macular degeneration (wet AMD), has announced its participation in Oppenheimer's 35th Annual Healthcare Life Sciences Conference.
The company's Chief Executive Officer, Frederic Guerard, PharmD, will deliver a presentation on Tuesday, February 11, 2025, at 10:00 AM ET and will be available for one-on-one meetings during the conference, which runs from February 11-12, 2025. The presentation will be accessible via webcast and will also be available on the company's investor relations website.
Opthea (ASX/NASDAQ:OPT) announced that its drug sozinibercept will be featured at the Macula Society 48th Annual Meeting, taking place February 12-15, 2025, in Charlotte Harbor, Florida. Dr. David S. Boyer will present data from the Phase 2b wet AMD trial during the Neovascular AMD I: Trials session on February 14, 2025.
The presentation will showcase findings demonstrating that sozinibercept 2 mg combination therapy achieved superior vision and anatomic outcomes compared to standard-of-care ranibizumab alone in treating wet age-related macular degeneration (wet AMD). The study also identified baseline angiographic lesion characteristics that were predictive of treatment response.
Opthea (ASX/NASDAQ:OPT) has announced multiple investor events to discuss sozinibercept developments in wet age-related macular degeneration (wet AMD) treatment. The company will host an Investor Day in New York City on January 28, 2025, at 1:30 PM ET, followed by presentations in Sydney (February 3) and Melbourne (February 5).
The events come as Opthea anticipates topline data readouts from two pivotal trials: COAST in early CY Q2 2025 and ShORe in mid-CY 2025. The New York event will feature presentations from retina specialist Dr. Charles C. Wykoff and Chief Commercial Officer Mike Campbell, focusing on sozinibercept's potential to improve vision outcomes in wet AMD patients and commercial readiness plans when combined with anti-VEGF-A therapies.
The New York session will conclude around 3:00 PM ET and include a Q&A segment. A replay will be available on the company's website, where registration links for all events can be found under the Investor Section's 'Events and Presentations'.
Opthea (OPT) has published Phase 1b clinical trial results for sozinibercept combination therapy in diabetic macular edema (DME) in the Translational Vision Science & Technology journal. The study evaluated nine patients receiving sozinibercept (0.3, 1, or 2 mg) combined with aflibercept (2 mg) every four weeks for twelve weeks.
The trial demonstrated that sozinibercept was well-tolerated with no dose-limiting toxicities. Results showed a dose-response relationship with increased visual acuity gains at higher doses, with the 2 mg combination showing the best results. All doses achieved meaningful central subfield thickness reduction.
The company plans to advance its DME program following anticipated Phase 3 topline data readouts for wet AMD from the COAST study in early Q2 2025 and ShORe in mid-2025. DME affects approximately 19 million people globally, with projections reaching 29 million by 2045.
Opthea (ASX/NASDAQ:OPT) has announced its participation in the 43rd Annual J.P. Morgan Healthcare Conference in San Francisco. CEO Frederic Guerard will present on January 15, 2025, at 5:15 PM PT, providing a business update that includes masked patient demographics and baseline characteristics from the sozinibercept Phase 3 wet AMD pivotal trials.
The clinical-stage biopharmaceutical company, focused on developing novel therapies for retinal diseases including wet age-related macular degeneration (wet AMD), will make its presentation available via webcast. The executive team will be available for one-on-one meetings from January 13-16, 2025. The presentation will be accessible through the company's website for 30 days following the event.
Opthea (ASX/NASDAQ:OPT) announced that its wet age-related macular degeneration (wet AMD) therapy, sozinibercept, will be featured in an oral presentation at the FLORetina Congress in Florence, Italy, December 5-8, 2024. The presentation titled 'Beyond VEGF-A Inhibition: Will Blocking VEGF-C and VEGF-D Lead to Better Outcomes?' will be delivered by Professor Adnan Tufail during the Retina Futura 1 session on December 6, 2024, at 11:25 AM CET.
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