Outlook Therapeutics Finishes Patient Enrollment for NOrse 1 Phase 3 Clinical Trial

Outlook Therapeutics (NASDAQ:OTLK) has announced it has finished enrolling patients in its NORSE i Phase 3 clinical trial evaluating ONS-5010 compared to ranibizumab in patients with wet AMD.

As quoted in the press release:

“We are pleased with the building momentum in our two ongoing Phase 3 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. I am very proud of our clinical development team’s work as we move this program forward in an effort to provide an approved bevacizumab treatment option for wet AMD patients around the world,” said Lawrence A. Kenyon, President, Chief Executive Officer and Chief Financial Officer.

NORSE 1 has enrolled a total of 61 patients at 9 sites in Australia. The study is the first of two ongoing, adequate and well controlled Phase 3 clinical trials evaluating ONS-5010 against ranibizumab for wet AMD. The endpoint for the study is a mean change in baseline visual acuity at 11 months for ONS-5010 dosed on a monthly basis compared to ranibizumab dosed using the PIER alternative dosing regimen of three monthly doses followed by quarterly dosing. The Company expects to announce a readout of the topline results from NORSE 1 in the third quarter of calendar 2020.

“The NORSE 1 study design was confirmed in our April 2018 FDA meeting to be one of our two adequate and well controlled clinical trials required to support approval of ONS-5010 to treat wet AMD. We are excited to complete each milestone in our effort to bring an approved anti-VEGF therapy to market for potential benefit to patients, payors, and physicians,” added Terry J. Dagnon Chief Operating Officer and a principal of MTTR LLC, the Company’s strategic partner for the ONS-5010 program.

Click here to read the full press release.