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Outlook Therapeutics Reports Positive Safety Profile from NORSE THREE Open-Label Safety Study for ONS-5010 / LYTENAVA™ (bevacizumab-vikg)
Positive safety profile in NORSE THREE open-label safety study reinforces previously reported safety data for ONS-5010 / LYTENAVA™, an investigational
About this update from Outlook Therapeutics, Inc.
[{"type":"text","content":"Positive safety profile in NORSE THREE open-label safety study reinforces previously reported safety data for ONS-5010 / LYTENAVA™, an investigational ophthalmic formulation of bevacizumab-vikg for the treatment of wet AMDTopline efficacy and safety data from pivotal Phase 3 NORSE TWO study on target to report in calendar Q3 2021, followed by BLA submission by end of 2021 MONMOUTH JUNCTION, N.J., March 31, 2021 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a late clinical-stage biopharmaceutical company developing the first FDA-approved ophthalmic formulation of bevacizumab-vikg for use in retinal indications, today announced positive topline results from its NORSE THREE open-label safety study evaluating ONS-5010 / LYTENAVA™ (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. “The additional validation of the ONS-5010 safety profile seen in the results of this study, which match up favorably with historical data from prior studies of bevacizumab in ophthalmology, is very encouraging. ONS-5010 has the potential to be a valuable therapeutic addition to the clinical practice of retina physicians. I look forward to the topline data readout from the pivotal safety and efficacy study later this year,” said Mark Humayun, MD, PhD, Medical Advisor to Outlook Therapeutics. NORSE THREE was conducted to ensure that an adequate number of patient exposures to ONS-5010 / LYTENAVA™ are available for Outlook Therapeutics’ data package for its planned biologics license applica...