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Replies to post #258 on Outlook Therapeutics Inc (OTLK)
Outlook Therapeutics Reports Positive Safety Profile from NORSE THREE Open-Label Safety Study for ONS-5010 / LYTENAVA™ (bevacizumab-vikg)
March 31, 2021
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 AMD
Topline 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 application (BLA) submission in the United States and for other global regulatory filings. The open-label study met its goal of ensuring that a sufficient number of individuals have now been treated with ONS-5010 by enrolling 197 treatment-naïve and previously treated subjects with a range of retinal diseases for which an anti-VEGF drug is a therapeutic option, including wet age-related macular degeneration (wet AMD), diabetic macular edema (DME) and branch retinal vein occlusion (BRVO). Subjects enrolled in the study received three monthly intravitreal doses of ONS-5010 / LYTENAVA™.
Following the data readout of the pivotal safety and efficacy study (NORSE TWO) later this year, Outlook Therapeutics plans to submit a new BLA filing under the PHSA 351(a) regulatory pathway in the fourth quarter of calendar 2021. If the BLA is 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.
Commercial launch planning for ONS-5010 has begun, including manufacturing, distribution, physician and patient outreach, and engagement with key opinion leaders and the payor community. With potential for an enhanced safety and cost-effectiveness profile, ONS-5010, if approved, is well positioned to become the first-line drug of choice in the United States for retinal indications and to be widely adopted by payors and clinicians worldwide in the $13.1 billion global anti-VEGF market.
“We are very pleased with the positive safety profile demonstrated by ONS-5010 in this open-label safety study. This study provided us with the necessary number of patient exposures to ONS-5010 to complete our planned BLA submission for wet AMD later this year,” said Lawrence A. Kenyon, President, CEO and CFO of Outlook Therapeutics. “These results reinforce the positive safety profile seen in our earlier clinical experience trial. Moving forward, our team is now laser-focused on successfully completing our pivotal trial, NORSE TWO, and preparing the BLA after the data readout expected in the third quarter of this calendar year. On behalf of the Outlook Therapeutics team, we would like to thank the clinicians and patients who participated in this study, despite the disruptions of the pandemic.”
In addition to the clinical development plan evaluating ONS-5010 for wet AMD, Outlook Therapeutics has received agreements from the FDA on three Special Protocol Assessments (SPAs) for three additional registration clinical trials. These SPAs cover the protocols for a planned registration clinical trial evaluating ONS-5010 to treat BRVO (NORSE FOUR), and two planned registration clinical trials evaluating ONS-5010 for the treatment of DME (NORSE FIVE and NORSE SIX). Outlook Therapeutics expects to initiate registration clinical trials for ONS-5010 for DME and BRVO later in 2021.
