Outlook Therapeutics Completes Patient Enrollment for NORSE 2 Study of ONS-5010 / LYTENAVA™ (bevacizumab-vikg)
- Pivotal NORSE 2 safety and efficacy data expected to be reported in the third calendar quarter of 2021
- ONS-5010 / LYTENAVA™ (bevacizumab-vikg) has the potential to be the first FDA-approved ophthalmic formulation of bevacizumab for use in multiple retinal indications
“We are extremely grateful to the patients and medical staff who continue to take part in this study, even amidst the effects of the COVID-19 pandemic. The hard work and dedication shown by these individuals have made it possible for us to achieve this important milestone, which now starts the clock to the completion of the study and to our reporting of pivotal data, expected in the third calendar quarter of 2021,” commented
The NORSE 2 clinical trial commenced patient enrollment in
“Within the retina community, the use of anti-VEGF therapy continues to be the standard of care for many ophthalmic diseases. Given the high cost of the present FDA-approved anti-VEGF therapies, many physicians have turned to off-label repackaged bevacizumab supplied by compounding pharmacists. There is significant unmet patient need for an FDA-approved bevacizumab for use in treating retinal diseases. I believe that LYTENAVA™, if approved, will offer clinicians an important new safe and effective, on-label anti-VEGF therapy option across the spectrum of retinal care,” commented
If approved, ONS-5010 will be the first and only on-label ophthalmic formulation of bevacizumab for treating retinal diseases and has the potential to address a
About ONS-5010 / LYTENAVA™ (bevacizumab-vikg)
ONS-5010 / LYTENAVA™ (bevacizumab-vikg) is an investigational ophthalmic formulation of bevacizumab under development to be administered as an intravitreal injection for the treatment of wet AMD and other retinal diseases. ONS-5010 is currently being evaluated in two adequate and well-controlled registration clinical trials for wet AMD (NORSE 1 and NORSE 2) and, if successful, is expected to be submitted to the FDA as a new BLA for this ophthalmic indication under the 351(a) regulatory pathway. If approved, ONS-5010 will be the first and only FDA-approved ophthalmic formulation of bevacizumab to treat retinal diseases.
ONS-5010 is a full-length, humanized anti-VEGF (Vascular Endothelial Growth Factor) recombinant monoclonal antibody (mAb) that inhibits VEGF and associated angiogenic activity. With wet AMD, abnormally high levels of VEGF are secreted in the eye. VEGF is a protein that promotes the growth of new abnormal blood vessels. 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.
This press release contains forward-looking statements. All statements other than statements of historical facts are “forward-looking statements,” including those relating to future events. In some cases, you can identify forward-looking statements by terminology such as “may,” “might,” “will,” “should,” “expect,” “plan,” “anticipate,” “project,” “believe,” “estimate,” “predict,” “potential,” “intend” or “continue,” the negative of terms like these or other comparable terminology, and other words or terms of similar meaning. These include statements about the timing of completion of, and pivotal safety and efficacy data from, NORSE 2, ONS-5010’s potential as the first FDA-approved ophthalmic formulation of bevacizumab, including benefits therefrom to patients, payors and physicians, the timing of BLA submission and commercial launch of ONS-5010, and plans for regulatory approvals in other markets. Although
For additional details on Outlook Therapeutics’ financial performance during the quarter, please see the
Chief Executive Officer
LaVoie Health Science
Source: Outlook Therapeutics, Inc.