Outlook Therapeutics Inc. (NASDAQ:OTLK) provided a clinical update for its investigational ophthalmic bevacizumab formulation, ONS-5010/LYTENAVA.
NORSE 1 and 2 studies to support BLA submission for ONS-5010
Currently, the company is conducting two ONS-5010 registration clinical studies. In 2018 at the end of the second phase meeting, the FDA approved the study design and size for the NORSE 1 & 2 trials, confirming that each of the two was acceptable. It indicated that the studies could support a Biologics License Application as per the 351(a) regulatory pathway for approval in treating wet age-related macular degeneration.
Lawrence Kenyon, the CEO, Outlook Therapeutics, indicated that the rest of this year will be an exciting period for the company with significant milestones for ONS-5010 expected in the next quarter. The CEO added that the agreed-upon FDA regulatory strategy, which includes the two registration ONS-5010 trials, offers a clear and important de-risked approval pathway. Kenyon added that the first major milestone for filing the new BLA will commence with the release of topline efficacy and safety data from the NORSE 1 study.
Outlook to release NORSE 1 results in August
The company expects to release the results from the NORSE 1 trial in August this year. These results will offer significant insight regarding ONS-5010’s safety administered monthly relative to the PIER dosing ranibizumab regimen that is administered quarterly. Kenyon also confirmed that the trial will enable the company to assess efficacy results for ONS-5010 in the treatment of wet-AMD. Despite these not being pivotal results, they will nevertheless set the stage for the company to proceed to NORSE 2 study.
Outlook Therapeutics completed enrolment in the NORSE 1 study in august last year and will report topline data this august. A total of 61 patients who had previously been treated or were treatment naïve were enrolled in nine study sites across Australia. The CEO affirmed that the company’s next step in the regulatory pathway for ONS-5010 is the current pivotal NORSE 2 clinical study that is on track to finalize enrolment in the next two months.