Currently, Opthea is conducting two concurrent pivotal Phase 3 registrational clinical trials, ShORe (Study of OPT-302 in combination with Ranibizumab) and COAST (Combination OPT-302 with Aflibercept Study) designed to evaluate the benefits of OPT-302 combination therapy for for wet AMD in treatment-naïve patients.
Opthea Limited (NASDAQ: OPT; ASX: OPT) is a public biotechnology company developing OPT-302, a novel biologic inhibitor of VEGF-C and VEGF-D, for use in combination with VEGF-A inhibitors for the treatment of wet age-related macular degeneration (wet AMD) and diabetic macular edema (DME).
Opthea has reported outcomes from:
- A Phase 1/2a clinical trial in the US investigating OPT-302 administered as a monotherapy, and in combination with the VEGF-A inhibitor ranibizumab (Lucentis®) in both newly diagnosed, treatment-naïve patients and patients previously treated with anti-VEGF-A monotherapy;
- A Phase 2b randomised, controlled clinical trial investigating OPT-302 administered in combination with Lucentis® compared to Lucentis® alone om treatment-naïve wet AMD patients; and
- A Phase 1b/2a clinical trial investigating OPT-302 administered in combination with aflibercept (Eylea®) for the treatment of persistent/refractory DME.
- Opthea’s technology is based on extensive intellectual property related to VEGF-C, VEGF-D and VEGFR-3 that is held in Opthea’s 100% owned subsidiary Vegenics Pty Ltd.
A brief history of Opthea Limited
Circadian Technologies changed its name to Opthea Limited in December 2015. Coinciding with the name change, the company’s ASX code changed from CIR to OPT.
Circadian Technologies was founded by Leon Serry and was one of Australia’s earliest biotechnology companies, listing on the Australian Securities Exchange in 1985.
Originally functioning as a commercial vehicle for outstanding, diverse biomedical research, the company successfully launched and spun out many of Australia’s most prominent biotechnology companies including Axon Instruments, Optiscan Imaging and Antisense Therapeutics.
In 2008, Circadian transformed its strategy to concentrate on the development of biologics-based therapies. In 2014, as Opthea, the company focussed operations on the commercial potential residing in OPT-302 for retinal eye diseases. The company’s programs leverage the broad intellectual property in respect of VEGF-C, VEGF-D and VEGFR-3, which is held within Opthea’s wholly-owned subsidiary, Vegenics Pty Ltd.