Opthea (ASX:OPT) has announced that enrollment in its pivotal Phase 3 clinical program of OPT-302 for the treatment of wet (neovascular) age-related macular degeneration (AMD) is now open in Europe.
The clinical-stage biopharmaceutical company is developing novel therapies to treat highly prevalent and progressive retinal diseases.
The two Phase 3 registrational clinical trials, ShORe (Study of OPT-302 in combination with Ranibizumab) and COAST (Combination OPT-302 with Aflibercept Study), will be conducted in up to 20 countries across Europe.
The company said the ShORe and COAST registrational studies are expected to each enrol approximately 990 treatment naïve patients. They are evaluating OPT-302 combination therapy as a potential treatment for wet AMD.
“We are excited to expand the ShORe and COAST trials outside North America to European investigative sites which is an important step in our continued commitment to improve the lives of patients around the world suffering from retinal diseases,” said Dr Megan Baldwin, CEO and managing director of Opthea.
“Europe represents another key market, given the large population of patients that reside there, and establishing a presence will help support the development of OPT-302, as well as future regulatory submissions and commercialization plans.”
Opthea is conducting ShORe and COAST as two concurrent global, multi-centre, double-masked, sham-controlled Phase 3 trials to assess the efficacy and safety of intravitreal 2.0 mg OPT-302 in combination with either 0.5 mg ranibizumab (Lucentis), or 2.0 mg aflibercept (Eylea) respectively.
The primary endpoint of both studies is the mean change in best-corrected visual acuity from baseline to week 52 for OPT-302 combination therapy compared to anti-VEGF-A monotherapy. The top-line 52-week data from the ShORe and COAST Phase 3 studies is anticipated in the second half of 2023.