Benzinga | Mar 31, 2021 08:11AM EDT

Outlook Therapeutics Reports Safety Profile From NORSE THREE Open-Label Safety Study For ONS-5010 / LYTENAVA; 10% Of PAtients Experienced Adverse Event

Outlook Therapeutics, Inc. (NASDAQ:OTLK), alate clinical-stagebiopharmaceutical companydeveloping the first FDA-approved ophthalmic formulation of bevacizumab-vikgfor use in retinalindications, today announced positive topline results from its NORSE THREE open-label safety study evaluating ONS-5010 / LYTENAVA(tm) (bevacizumab-vikg) to treat retinal diseases.

Topline results from the open-label safety study demonstrated that ONS-5010 showed no unexpected safety trends and had a safety profile consistent with that of prior published data on the use of bevacizumab for ophthalmic conditions, such as the 2011 CATT study undertaken by the National Eye Institute. The safety endpoints for NORSE THREE were the frequency and incidence of treatment-emergent adverse events and an evaluation of changes in safety parameters. In the study, 20 out of 197 patients (10%) experienced an adverse event in the study eye that were most commonly associated with the injection procedure and not ONS-5010. There were no serious adverse events associated with treatment. Notably, there were zero cases of ocular inflammation, a concern that has emerged for other anti-VEGF (Vascular Endothelial Growth Factor) therapies to treat retinal conditions.