Clinical stage biopharmaceutical company Opthea (ASX:OPT), which is developing novel therapies to treat progressive retinal diseases, has announced that recruitment is open to patients in Canada for the Phase 3 pivotal clinical program of OPT-302 for the treatment of wet (neovascular) age-related macular degeneration (AMD).
The company said patient enrollment in the two concurrent Phase 3 registrational clinical trials, ShORe (Study of OPT-302 in combination with Ranibizumab) and COAST (Combination OPT-302 with Aflibercept Study), can now begin in Canada following authorisation from the country's regulatory agency.
"The goal of the two studies is to evaluate the benefits of the Company’s VEGF-C/D ‘trap’ inhibitor, OPT-302, for wet AMD in treatment-naïve patients," said the company.
The Phase 3 pivotal clinical program has already begun in the US.
The company said it is also advancing towards approval from national regulatory agencies and ethics committees in other countries, including those in Europe, South American and the Asia Pacific regions.
“Expanding our global reach for the Phase 3 pivotal program is an important milestone for Opthea, and this is the first time clinical trials have been conducted in Canada to investigate OPT-302 in patients with retinal disease,” said managing director and CEO Dr Megan Baldwin.
“We believe that OPT-302, if successful in Phase 3 and approved, has the potential to improve the trajectory of wet AMD disease progression. Therefore, we are working with regulatory authorities worldwide to initiate the Phase 3 registrational clinical trials as quickly as possible in other countries.”
The US FDA recently granted OPT-302 Fast Track designation based on positive safety and efficacy results from Opthea’s previous Phase 1/2 and Phase 2b clinical studies in wet AMD.