Positive Safety Profile Reported for ONS-5010 / LYTENAVA for Wet AMD

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

ONS-5010 is a full-length, humanized anti-VEGF (Vascular Endothelial Growth Factor) recombinant monoclonal antibody (mAb) that inhibits VEGF and associated angiogenic activity. VEGF is a protein that promotes the growth of new abnormal blood vessels. With wet AMD, abnormally high levels of VEGF are secreted in the eye and can lead to vision loss. Anti-VEGF injection therapy blocks this growth. Since the advent of anti-VEGF therapy, it has become the standard-of-care treatment option within the retina community globally.

If approved, ONS-5010 will be the first and only FDA-approved ophthalmic formulation of bevacizumab-vikg to treat retinal diseases. Outlook Therapeutics currently intends to initiate registration trials for diabetic macular edema (DME) and branch retinal vein occlusion (BRVO) and to commercialize ONS-5010 in both vials and single-use pre-filled syringes.

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.

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™.

“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.