- Clinical stage biopharmaceutical company Opthea (OPT) has finalised the design of two pivotal phase three trials of OPT-302
- In separate trials, the company will assess the drug candidate in combination with Lucentis and Eylea standard of care treatments in patients with wet age-related macular degeneration (AMD)
- The trial design was finalised in consultation with the FDA as well as the EMA and has been submitted to the relevant regulatory authorities
- Opthea maintains it’s on track to initiate the trials in the first quarter of the 2021 calendar
- Shares closed 5.3 per cent lower at $1.60
Opthea (OPT) has finalised the design of two pivotal phase three trials of OPT-302 in patients with wet age-related macular degeneration (AMD).
In separate trials, the company will assess the drug candidate in combination with Lucentis and Eylea standard of care treatments in study’s called ShORe and COAST, respectively.
Each trial will be rolled out at multiple centres globally and enrol approximately 990 patients each to test the efficacy and safety of the combinations.
The clinical stage biopharmaceutical company finalised the trial design in consultation with the FDA, the EMA and thought leaders in the field.
“With the achievement of other key start-up milestones, including successful scale-up of manufacturing and fill-finish of OPT-302 drug product for use in the trials, we now excitedly look forward to initiating the pivotal Phase 3 studies that are designed to support potential marketing approval of OPT-302 for the treatment of wet AMD,” added CEO Dr Megan Baldwin.
The trial protocols are now been submitted to relevant regulatory agencies, institutional review boards and human research ethics committees for consideration.
Opthea maintains it’s on track to initiate the trials in the first quarter of the 2021 calendar.
Shares closed 5.3 per cent lower at $1.60.