Outlook Therapeutics Inc (OTLK)

[H2R]

Positive results from NORSE THREE study in retinal disease

Mar. 31, 2021 8:20 AM ET

Outlook Therapeutics (NASDAQ:OTLK) announces positive topline results from its NORSE THREE study evaluating ONS-5010/LYTENAVA (bevacizumab-vikg) to treat retinal diseases. ONS-5010 showed no unexpected safety trends and had a safety profile consistent with that of prior data on the use of bevacizumab for ophthalmic conditions.

The safety endpoints for NORSE THREE were the frequency and incidence of treatment-emergent adverse events and changes in safety parameters.

In the study, 20 out of 197 patients (10%) experienced an adverse event most commonly associated with the injection procedure and not ONS-5010. There were zero cases of ocular inflammation.

Following the data readout of NORSE TWO later this year, Outlook plans to submit a new BLA filing in Q4.

If approved, it will result in 12 years of marketing exclusivity for ONS-5010/LYTENAVA as the first and only FDA-approved ophthalmic formulation of bevacizumab-vikg to treat wet AMD.

OTLK shares up 2.8% premarket trading at $2.24.

https://seekingalpha.com/news/3678013-outlook-therapeutics-reports-positive-results-from-norse-three-study-in-retinal-disease


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