Opthea (ASX: OPT) — Company Overview, News & Financial Data
Opthea is a clinical-stage biopharmaceutical company developing gene therapies for various ophthalmic diseases, including wet AMD.
Opthea
Opthea is a clinical-stage biopharmaceutical company focused on the development and commercialization of novel biologic therapies for rare lung diseases and vascular eye disorders. Its lead candidate, CYV-101, is a soluble receptor fusion protein designed to block vascular endothelial growth factors VEGF-C and VEGF-D. The drug is targeted at treating lymphangioleiomyomatosis, a rare, progressive cystic lung disease primarily affecting women. The company leverages Australian scientific innovation to advance clinical trials, secure orphan drug designations, and scale manufacturing for global regulatory approvals and patient accessibility.
Snapshot
Operations
Products and/or services of Opthea
- Lymphangioleiomyomatosis Therapy Development: Clinical-stage evaluation of a soluble fusion protein targeting vascular endothelial growth factors C and D to inhibit dysregulated lymphatic vessel proliferation and preserve lung function in female patients with lymphangioleiomyomatosis.
- Phase 1b Clinical Trials: Execution of early-to-mid stage human clinical studies assessing safety, tolerability, pharmacokinetics, and preliminary therapeutic efficacy of anti-VEGF-C/D biologic candidates in patients diagnosed with rare progressive pulmonary disorders.
- Inhaled Formulation Engineering: Research and development of novel nebulized and aerosolized drug delivery formulations designed to enable direct pulmonary administration and targeted local action within affected lung tissues.
- Regulatory and Orphan Drug Strategy: Engagement with international health authorities to secure orphan drug designations, priority review status, and regulatory pathways across target jurisdictions in North America, Europe, and Australia.
- Biopharmaceutical Manufacturing Scale-Up: Management of chemistry, manufacturing, and controls processes, including cell line development, upstream fermentation, downstream purification, and batch scale-up to support Phase 2 and commercial supply readiness.
- Translational Research and Patient Registries: Partnerships with specialized clinical research institutes and medical facilities to track disease registries, evaluate patient-reported outcomes, and analyze VEGF signalling biomarkers in rare pulmonary diseases.
Opthea executive team
- Dr. Jeremy Max Levin Ba Zoology, Dphil, M.D., Mb Bchir, Ph.D.CEO & Chairperson
- Mr. Hamish GeorgeCFO & Joint Company Secretary
- Ms. Stephanie VipondJoint Company Secretary