[{"orgOrder":0,"company":"Opthea","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Opthea Completes Patient Dosing in Phase 2a DME Trial","therapeuticArea":"Ophthalmology","highestDevelopmentStatus":"Phase I\/ Phase II","country":"AUSTRALIA","productType":"Large molecule","productStatus":"New Molecular Entity","date":"March 2020","url1":"","url2":"","graph1":"Ophthalmology","graph2":"Phase I\/ Phase II"},{"orgOrder":0,"company":"Opthea","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Opthea Reports Positive Phase 2a Trial Results of OPT-302 in Diabetic Macular Edema","therapeuticArea":"Ophthalmology","highestDevelopmentStatus":"Phase I\/ Phase II","country":"AUSTRALIA","productType":"Large molecule","productStatus":"New Molecular Entity","date":"June 2020","url1":"","url2":"","graph1":"Ophthalmology","graph2":"Phase I\/ Phase II"},{"orgOrder":0,"company":"Opthea","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Opthea Reports New Data of OPT-302 in Diabetic Macular Edema at the 2020 Annual Meeting of the American Society of Retina Specialists","therapeuticArea":"Ophthalmology","highestDevelopmentStatus":"Phase I\/ Phase II","country":"AUSTRALIA","productType":"Large molecule","productStatus":"New Molecular Entity","date":"July 2020","url1":"","url2":"","graph1":"Ophthalmology","graph2":"Phase I\/ Phase II"},{"orgOrder":0,"company":"Opthea","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Opthea Completes Successful Meetings with FDA and EMA for OPT-302 Phase 3 Clinical Program in Wet AMD","therapeuticArea":"Ophthalmology","highestDevelopmentStatus":"Phase II","country":"AUSTRALIA","productType":"Large molecule","productStatus":"New Molecular Entity","date":"August 2020","url1":"","url2":"","graph1":"Ophthalmology","graph2":"Phase II"},{"orgOrder":0,"company":"Opthea","sponsor":"Undisclosed","pharmaFlowCategory":"D","amount":"$150.0 million","upfrontCash":"Undisclosed","newsHeadline":"Opthea Files for a $150 Million US IPO","therapeuticArea":"Ophthalmology","highestDevelopmentStatus":"Phase II","country":"AUSTRALIA","productType":"Large molecule","productStatus":"New Molecular Entity","date":"September 2020","url1":"","url2":"","graph1":"Ophthalmology","graph2":"Phase II"},{"orgOrder":0,"company":"Opthea","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Opthea Finalizes Study Designs and Start-Up Activities for Phase 3 Pivotal Clinical Trials of OPT-302 in Wet AMD","therapeuticArea":"Ophthalmology","highestDevelopmentStatus":"Phase III","country":"AUSTRALIA","productType":"Large molecule","productStatus":"New Molecular Entity","date":"February 2021","url1":"","url2":"","graph1":"Ophthalmology","graph2":"Phase III"},{"orgOrder":0,"company":"Opthea","sponsor":"Novartis Pharmaceuticals Corporation","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Opthea\u2019s OPT-302 Granted FDA Fast Track Designation for Wet Age-Related Macular Degeneration","therapeuticArea":"Ophthalmology","highestDevelopmentStatus":"Phase III","country":"AUSTRALIA","productType":"Large molecule","productStatus":"New Molecular Entity","date":"July 2021","url1":"","url2":"","graph1":"Ophthalmology","graph2":"Phase III"},{"orgOrder":0,"company":"Opthea","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Opthea Expands Global Phase 3 ShORe and COAST Wet AMD Trials of OPT-302 into Canada","therapeuticArea":"Ophthalmology","highestDevelopmentStatus":"Phase III","country":"AUSTRALIA","productType":"Large molecule","productStatus":"New Molecular Entity","date":"August 2021","url1":"","url2":"","graph1":"Ophthalmology","graph2":"Phase III"},{"orgOrder":0,"company":"Opthea","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Opthea Opens Patient Recruitment in Europe for Pivotal Phase 3 ShORe and COAST Wet AMD Trials of OPT-302","therapeuticArea":"Ophthalmology","highestDevelopmentStatus":"Phase III","country":"AUSTRALIA","productType":"Large molecule","productStatus":"New Molecular Entity","date":"October 2021","url1":"","url2":"","graph1":"Ophthalmology","graph2":"Phase III"},{"orgOrder":0,"company":"Opthea","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Opthea Opens Patient Enrollment in the Asia-Pacific Region for the OPT-302 ShORe and COAST Phase 3 Trials in Wet AMD","therapeuticArea":"Ophthalmology","highestDevelopmentStatus":"Phase III","country":"AUSTRALIA","productType":"Large molecule","productStatus":"New Molecular Entity","date":"October 2021","url1":"","url2":"","graph1":"Ophthalmology","graph2":"Phase III"},{"orgOrder":0,"company":"Opthea","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Opthea Data for OPT-302 in Patients with Polypoidal Choroidal Vasculopathy (PCV) Presented at Angiogenesis 2022","therapeuticArea":"Ophthalmology","highestDevelopmentStatus":"Phase III","country":"AUSTRALIA","productType":"Large molecule","productStatus":"New Molecular Entity","date":"February 2022","url1":"","url2":"","graph1":"Ophthalmology","graph2":"Phase III"},{"orgOrder":0,"company":"Opthea","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Opthea Presenting Clinical Data at ARVO 2022 Annual Meeting","therapeuticArea":"Ophthalmology","highestDevelopmentStatus":"Phase III","country":"AUSTRALIA","productType":"Large molecule","productStatus":"New Molecular Entity","date":"April 2022","url1":"","url2":"","graph1":"Ophthalmology","graph2":"Phase III"},{"orgOrder":0,"company":"Opthea","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Opthea Data for OPT-302 in Combination with Ranibizumab for Polypoidal Choroidal Vasculopathy (PCV) Presented at ARVO 2022","therapeuticArea":"Ophthalmology","highestDevelopmentStatus":"Phase III","country":"AUSTRALIA","productType":"Large molecule","productStatus":"New Molecular Entity","date":"May 2022","url1":"","url2":"","graph1":"Ophthalmology","graph2":"Phase III"},{"orgOrder":0,"company":"Opthea","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Opthea Phase 2b Trial Results of OPT-302 in Combination with Lucentis\u00ae for wet AMD Published in the Journal Ophthalmology","therapeuticArea":"Ophthalmology","highestDevelopmentStatus":"Phase III","country":"AUSTRALIA","productType":"Large molecule","productStatus":"New Molecular Entity","date":"February 2023","url1":"","url2":"","graph1":"Ophthalmology","graph2":"Phase III"},{"orgOrder":0,"company":"Opthea","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Opthea Announces \u201cSozinibercept\u201d as the Nonproprietary Drug Name for OPT-302","therapeuticArea":"Ophthalmology","highestDevelopmentStatus":"Phase III","country":"AUSTRALIA","productType":"Large molecule","productStatus":"New Molecular Entity","date":"July 2023","url1":"","url2":"","graph1":"Ophthalmology","graph2":"Phase III"},{"orgOrder":0,"company":"Opthea","sponsor":"Undisclosed","pharmaFlowCategory":"D","amount":"$57.6 million","upfrontCash":"Undisclosed","newsHeadline":"Opthea Successfully Completes Institutional Offer and Increases Capital Raising to A$90.0M (US$57.6 million\u00b9)","therapeuticArea":"Ophthalmology","highestDevelopmentStatus":"Phase III","country":"AUSTRALIA","productType":"Large molecule","productStatus":"New Molecular Entity","date":"August 2023","url1":"","url2":"","graph1":"Ophthalmology","graph2":"Phase III"}]
Find Clinical Drug Pipeline Developments & Deals by Opthea
The company intends to use the net proceeds for advancing the Phase 3 clinical trials ShORe and COAST for OPT-302 (sozinibercept), a novel inhibitor of vascular endothelial growth factor (VEGF)-C and VEGF-D, for the treatment of wet AMD.
OPT-302 (sozinibercept) is a novel recombinant trap fusion protein targeting inhibition of vascular endothelial growth factors C and D (VEGF-C and VEGF-C), two ligand mediators of angiogenesis and vascular leakage involved in retinal vascular diseases.
OPT-302, a VEGF-C/D inhibitor being investigated for neovascular age-related macular degeneration. It binds to and neutralizes the activity of VEGF-C and VEGF-D by preventing ligand binding to the endogenous receptors VEGFR-2 and VEGFR-3.
Of the 366 participants dosed for OPT-302, 66 (18%) were identified as having PCV lesions at baseline based on multimodal imaging analysis of color fundus photography, fluorescein angiography and SD-OCT.
OPT-302 is a first-in-class VEGF-C/D inhibitor. It is a soluble fusion protein comprising immunoglobulin-like domains 1 to 3 of extracellular domain of vascular endothelial growth factor receptor 3 fused to Fc fragment of human IgG1.
The data presented was a prespecified subgroup analysis of a Phase 2b dose-ranging study of intravitreal OPT-302 in combination with ranibizumab, compared with ranibizumab alone, in participants with neovascular age-related macular degeneration (wet AMD).
OPT-302, a VEGF-C/D ‘trap’, to be used in combination with existing standard of care anti-VEGF-A therapies. OPT-302 has the potential to address the unmet medical need of wet age-related macular degeneration (AMD) and diabetic macular edema (DME) patients.
The ShORe and COAST registrational studies are expected to each enroll approximately 990 treatment naïve patients and are evaluating OPT-302 combination therapy as a potential treatment for wet AMD.
The initiation of the Phase 3 pivotal clinical program follows the positive outcomes from the Phase 2b clinical trial of OPT-302 in 366 patients with wet AMD, which demonstrated that OPT-302, in combination with standard of care anti-VEGF-A therapy, ranibizumab (Lucentis).
This Fast Track designation acknowledges the significant unmet medical need in the management of neovascular AMD, and the potential role that OPT-302 may have in addressing it.