Outlook Therapeutics completes enrollment in Phase 3 wet AMD trial

Outlook Therapeutics (NASDAQ:OTLK) completed patient enrollment in its Phase 3 clinical trial comparing ONS-5010 to ranibizumab for the treatment of wet age-related macular degeneration (AMD).

Administered via intravitreal injection, ONS-5010 is an ophthalmic formulation of bevacizumab, a humanized anti-VEGF antibody that is designed to inhibit angiogenesis.

The trial enrolled 61 patients at nine Australian sites and is the first of two ongoing Phase 3 clinical trials evaluating ONS-5010 against ranibizumab for wet AMD. The study’s endpoint is mean change in baseline visual acuity at 11 months.

“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,” Lawrence Kenyon, Outlook’s president, CEO and CFO, said in a statement.

Outlook expects topline data from the trial in the third quarter of 2020.


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