Outlook Therapeutics Inc (OTLK)

[H2R]

Sept 13th, positive signals

Outlook Therapeutics’ wet AMD ONS-5010 clinical program for the planned BLA submission consists of three clinical trials, NORSE ONE, NORSE TWO, and NORSE THREE, all of which have now been completed. Most recently, Outlook Therapeutics reported positive topline data from its NORSE TWO pivotal Phase 3 clinical trial. In NORSE TWO, ONS-5010 achieved statistically significant and clinically relevant primary (p = 0.0052) and key secondary (p = 0.0043) efficacy endpoints with 41% of subjects gaining at least 15 letters of BVCA. ONS-5010 was also found to be safe and well tolerated in the NORSE TWO trial.

With the registration clinical trials now completed, Outlook Therapeutics plans to submit a new BLA under the Public Health Service Act (PHSA) 351(a) regulatory pathway in the first quarter of calendar 2022. If the BLA is approved, it is expected to result in 12 years of marketing exclusivity for ONS-5010 as the first and only ophthalmic formulation of bevacizumab approved by the FDA to treat wet AMD.

https://ir.outlooktherapeutics.com/news-releases/news-release-details/outlook-therapeutics-presents-positive-norse-three-safety-data

Looking good!