Outlook Therapeutics' Bevacizumab-vikg Shows Favorable Safety Profile In Retinal Disease Study

Outlook Therapeutics Inc OTLK has announced positive topline results from its NORSE THREE open-label safety study evaluating ONS-5010 / LYTENAVA (bevacizumab-vikg) to treat retinal diseases.

• Data demonstrated that ONS-5010 showed no unexpected safety trends and had a safety profile consistent with prior published data on the use of bevacizumab for ophthalmic conditions.
• In the study, 20 out of 197 patients (10%) experienced an adverse event in the study eye that was most commonly associated with the injection procedure and not ONS-5010.
• Zero cases of ocular inflammation were reported, a concern that has emerged for other anti-VEGF (Vascular Endothelial Growth Factor) therapies to treat retinal conditions.
• Following the data readout of the pivotal safety and efficacy study (NORSE TWO) later this year, the company plans to submit a new marketing application under the PHSA 351(a) regulatory pathway in Q4.
• It expects to initiate registration clinical trials for ONS-5010 for diabetic macular edema and branch retinal vein occlusion later in 2021.
• ONS-5010 is a full-length, humanized anti-VEGF recombinant monoclonal antibody administered as an intravitreal injection.
• It inhibits VEGF and associated angiogenic activity that is responsible promote the growth of new abnormal blood vessels.
• With wet AMD, abnormally high VEGF levels are secreted in the eye and can lead to vision loss.
• Price Action: OTLK shares down 0.9% at $2.18 in premarket trading on the last check Wednesday.