Outlook Therapeutics has concluded the enrolment of patients in a Phase III clinical trial of ONS-5010 for the treatment of patients with wet age-related macular degeneration (wet AMD).
An ophthalmic formulation, ONS-5010 is a bevacizumab product candidate developed to treat retinal diseases, including wet AMD.
Bevacizumab is a humanised antibody that blocks the vascular endothelial growth factor (VEGF) and related angiogenic activity.
ONS-5010 has been formulated as an anti-VEGF recombinant humanised monoclonal antibody for intravitreal administration.
Called NORSE 1, the Phase III trial is designed to compare ONS-5010 with ranibizumab (Lucentis). The study recruited 61 patients at nine clinical sites across Australia.
The trial’s endpoint is a mean change in baseline visual acuity at 11 months with a once-monthly dose of ONS-5010 compared to ranibizumab given as three monthly doses followed by quarterly dosing.
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Top-line data from the Phase III NORSE 1 study is expected to be reported next year.
Outlook Therapeutics president, CEO and chief financial officer Lawrence Kenyon said: “We are pleased with the building momentum in our two ongoing Phase III clinical trials for ONS-5010, including completing enrollment in NORSE 1.
“Achieving this milestone keeps us on track for our goal to submit ONS-5010 for regulatory approval in the United States in 2020, pending the successful outcome of our trials.”
NORSE 1 is the first of two ongoing adequate Phase III studies comparing ONS-5010 to ranibizumab in wet AMD patients.
Data from the ONS-5010 clinical programme is expected to support the company’s application seeking regulatory approval for the compound in various markets.
If approved, the therapeutic could help address risks that come with off-label use of other wet AMD medicines.