Outlook Therapeutics Inc (OTLK)

[H2R]

Q1 2022 BLA planned: Consistent Timelines

The company keeps to its timeline announced earlier in October.

Based on the strong data from this clinical program, 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 in the US for ONS-5010 as the first and only ophthalmic formulation of bevacizumab approved by the FDA to treat wet AMD.

The NORSE TWO pivotal data met both primary and secondary endpoints with statistically significant and clinically relevant results:

* 41.7% (p = 0.0052) ONS-5010 subjects gained ≥ 15 letters of vision
* 56.5% (p = 0.0016) ONS-5010 subjects gained ≥ 10 letters of vision
* 68.5% (p = 0.0116) ONS-5010 subjects gained ≥ 5 letters of vision
* ONS-5010 subjects gained 11.2 letters (p = 0.0043) in BCVA

https://ir.outlooktherapeutics.com/news-releases/news-release-details/outlook-therapeutics-presents-norse-two-phase-3-pivotal-safety

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